AUGUST 2008
WEEK ENDING AUGUST 2
PRODUCT
a)
Levitronix CentriMag Primary System, Article Number:
201-30100; extracorporeal blood circulation system,
b) Levitronix CentriMag Back-Up Console Article Number:
201-30200; extracorporeal blood circulation system,
CODE
All serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Levitronix, Llc, Waltham, MA,
Manufacturer:
Levitronix, GmbH, Zurich, Switzerland.
REASON Stops pumping:
Interruption of CentriMag System support may occur when using a ValleyLab Force
FX-C Electrocautery Unit.
VOLUME OF PRODUCT IN
COMMERCE 630 primary units/237 units back
up
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Biomet
Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile; Part 183448,
b) Biomet
Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile; Part 183464,
CODE
a) Lot 743430;
b) Lot
743470
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw,
IN,
REASON Mislabeled: The packaging of the two
products was mixed up, resulting in the products being labeled with an incorrect
size. If implanted, the product may not fit properly, which could require repeat
surgery. The problem could also result in a delay in the
procedure.
VOLUME OF PRODUCT IN COMMERCE 12
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Medline EndurO2 Oxygen Concentrator with Oxygen Monitor;
Portable oxygen generator; Reorder Number: HCS02;
Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been
prescribed oxygen therapy by a physician,
b) Medline EndurO2 Oxygen Concentrator without Oxygen Monitor;
Portable oxygen generator; Reorder Number: HCS021;
Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed
oxygen therapy by a physician,
CODE All units produced since July
2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline
Industries Inc, Mundelein IL,
Manufacturer: EMG Technology Co., Ltd, Taya Hsiang,
Taichung Hsien, Taiwan.
REASON Overheating of Components: There is the potential
for an electrical component in the oxygen concentrator to overheat, causing
damage to the unit and making it nonfunctional.
VOLUME OF PRODUCT IN
COMMERCE 6,453
units
DISTRIBUTION Nationwide
PRODUCT AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle
Enzyme Immunoassay that determines amount of human thyroid stimulating hormone
in human serum and plasma,
CODE Lot
50082Q100 Exp Date 02/23/2008, Lot 52369Q100 Exp Date 04/20/2008, Lot #
53620Q100 Exp Date 06/26/2008 and Lot # 57518Q100 Exp Date
09/07/2008
RECALLING FIRM/MANUFACTURER Abbott Diagnostic
International, Ltd., Barceloneta, PR,
REASON High Control value
out of range after calibration. An increased Frequency of High Control Values
Beyond the Upper Limit of the Range Specified by the Package
Insert.
VOLUME OF PRODUCT IN COMMERCE 882
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Triathlon TS Femoral Trial; Size 1 Left Non-Sterile Catalog
Number 5512-T-101, Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
b) Triathlon TS Femoral Trial; Size 1 Right Non-Sterile Catalog
Number: 5512-T-102; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
c) Triathlon TS Femoral Trial; Size 2 Left Non-Sterile Catalog
Number 5512-T-201; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
d) Triathlon TS Femoral Trial; Size 2 Right Non-Sterile Catalog
Number: 5512-T-202; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
e) Triathlon TS Femoral Trial; Size 3 Left Non-Sterile Catalog
Number: 5512-T-301; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
f) Triathlon TS Femoral Trial Size 3 Right Non-Sterile Catalog
Number : 5512-T-302; Orthopedic Manual Surgical
Instrument indicated for use in revision Total Knee Arthroplasty,
g) Triathlon TS Femoral Trial; Size 4 Left Non-Sterile Catalog
Number: 5512-T-401; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
h) Triathlon TS Femoral Trial; Size 4 Right
Non-Sterile Catalog Number: 5512-T-402; Orthopedic Manual
Surgical Instrument indicated for use in revision Total Knee Arthroplasty,
i) Triathlon TS Femoral Trial; Size 5 Left Non-Sterile
Catalog Number: 5512-T-501; Orthopedic Manual Surgical
Instrument indicated for use in revision Total Knee Arthroplasty,
j) Triathlon TS Femoral Trial; Size 5 Right Non-Sterile Catalog
Number: 5512-T-502; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
k) Triathlon TS Femoral Trial; Size 6 Left Non-Sterile Catalog
Number: 5512-T-601; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
l) Triathlon TS Femoral Trial; Size 6 Right Non-Sterile Catalog
Number: 5512-T-602; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
m) Triathlon TS Femoral Trial; Size 7 Left Non-Sterile Catalog
Number: 5512-T-701; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
n) Triathlon TS Femoral Trial; Size 7 Right Non-Sterile Catalog
Number: 5512-T-702; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
o) Triathlon TS Femoral Trial; Size 8 Left Non-Sterile Catalog
Number: 5512-T-801; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
p) Triathlon TS Femoral Trial; Size 8 Right Non-Sterile Catalog
Number: 5512-T-802; Orthopedic Manual Surgical Instrument
indicated for use in revision Total Knee Arthroplasty,
CODE
a) Lot Code:
WFLD;
b) Lot Code: WFLI;
c) Lot Code: WFLV;
d) Lot Codes: TYHMPD, WFCP;
e) Lot Codes:
N4TMPD, PDAMPD, WEWC;
f) Lot Code: WFIC;
g) Lot Codes: N4WMPD, PDVMPD,
WFCY;
h) Lot Codes:N4XMPD,WFDC;
i) Lot Code: WFCC;
j) Lot codes:N50MPD,
WFKF;
k) Lot code: WFFB;
l) Lot Code: WFIZ;
m) Lot Code: WFIP,
1TXMRD;
n) Lot Codes: V04MPD, WEVN;
o) Lot Code: WFJY;
p) Lot code:
WFIT
RECALLING FIRM/MANUFACTURER Stryker Howmedica
Osteonics Corp., Mahwah, NJ,
REASON Sharp edges will cause a
glove to tear
and cut someone. Sharp edges on the slots machines in select lots of the
Triathlon TS Femoral Trials, sizes 1-8, have been discovered.
VOLUME
OF PRODUCT IN COMMERCE 106
units
DISTRIBUTION Nationwide
PRODUCT
a) Medtronic Affinity NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Resistant Fiber.
Single Use gas exchange device for Cardiopulmonary
Bypass. Catalog Number: 71166,
b) Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass
Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB1Z69R12, CB1Z69R12, CB1Z85R16, CB2503R1, CB2K59R8, CB2K59R8,
CB2S52R4, CB2U05R1, CB2W86R2, CB3E29R5, CB3L87R4, CB3U53R7, CB3X44R4, CB4741R15, CB4E05R6, CB4F32R3, CB4F32R3, CB4F32R3, CB4G10R5, CB4Q81R, CB4S04R2,
CB4T12R2,
CB4W67R3, CB5N65R2, HY1709R34, HY3B29R13,
HY4X31R7, HY5C74R15, HY5H32R5, HY5L38R1, HY5L72R1,
HY5R03R, and TL2L66R5,
c)
Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Catalog Number: CB4014,
d) Medtronic Affinity NT Hollow Fiber Oxygenator with Plasma
Resistant with Carmeda BioActive Surface, Catalog
Number: CB511, CB5201R14, and CB5227R4,
e) Medtronic Venous Cannula with bent tip wire, for vascular
cardiopulmonary bypass. Catalog Number: CB67532,
f) Medtronic Malleable Single Stage Venous Cannula with Carmeda
BioActive Surface, for Vascular Cardiopulmonary Bypass.
Catalog Number: CB68122,
g)
Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbers: CB71424, CB77008, and CB77010,
h) Medtronic Select 3D and Select CAP Aterial
Cannulae with flexible, thin wall wire-wound PVC bodies
with angled, beveled tips. Catalog Number: CB78722,
i) Medtronic Arterial Cannula Curved Beveled Tip, for
Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022,
j) Medtronic
Bio-Medicus Femoral Cannula/Introducer,
for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023,
CB96345-023, and CB96345-029,
k) Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015,
l)
Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only available
OUS. Catalog
number: M470450E,
CODE
a) Lot numbers: 9821992, 9826735;
b)
Lot numbers: 9871463, 9904942, 9818263, 9887322, 9872639, 9568381, 9805685, 9819156, 9816273, 9879856, 9816253, 9819175,
9882568, 9834608, 9812228, 9819173, 9839338, 9894969,
9837298, 9823284, 9892093, 9819157, 9819650, 9867648,
9885608, 9866753, 9841997, 9861563, 9837302, 9904072,
9818265, 9895128, 9864540, 9838652, 9879895, 9859513,
9882604, 9861103, 9859465;
c) Lot numbers: CB4014 / 9827678;
d) Lot
numbers: 9816345, 9828465, 9879857;
e) Lot number: 9816217;
f) Lot number:
9816218;
g) Lot numbers: 9816219, 9816221, 9816222;
h) Lot number:
9807485;
i) Lot numbers: 9890943, 9816224;
j) Lot numbers: 9890956,
CB96345-023 / 9890955, CB96345-029 / 9866550;
k) Lot number: 9890940;
l)
Lot number: 200968580
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medtronic
International Trade Inc, Brooklyn Park, MN,
Manufacturer: Medtronic Mexico, S. De R. L. De
C.V, Tijuana, Baja California, Mexico.
REASON Products were manufactured with heparin that were
contaminated with oversulfated chondroitin sulfate (OSCS).
VOLUME OF
PRODUCT IN COMMERCE 844
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with
Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215,
95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 1702R51,
1A11R16, 1A19R26, 1B22R5, 1F66R12, 1G47R4, 1K86R3, 1K93R5, 1L71R20, 1M05R12,
1P07R6, 1X24R, 2892R18, 2D64R12, 2E55R9, 2N90R8, 2V85R4, 3B89R12, 3C98R7,
3P11R4, 3R39R2, 3R42R14, 4B46R16, 4E58R16, 4F13R2, 4J01R7, 4Q39R1, 4R68R5,
4R68R6, 4W65R, 4X44R7, 5633R30, 5C89R2, 5D83R, 5R69R1, 5U35R, 9059R20, 9243R19,
CB0A12R15, CB2T58R4, CB3L15R5, CB4D99R4, CB4E05R6, CB4J24R2, CB4J67R1, CB4K47R1,
CB4K64R5, CB5B53R, CB5C01R2, CB5C82R9, CB5P29R4, CB5Q88R, CB5S97R2, DP38T,
HY0W55R17, HY0Y86R17, HY1709R34, HY1C73R16, HY2F13R22, HY2F13R23, HY2J04R2,
HY2K12R5, HY2K16R5, HY2K51R14, HY2K60R3, HY2Q31R1, HY2Q32R2, HY2T49R3, HY2U43R5,
HY2U98R5, HY2W85R9, HY3B29R13, HY3C53R1, HY3E77R13, HY3H52R13, HY3L42R12,
HY3L78R1, HY3M41R4, HY3M43R1, HY3M45R1, HY3Q11R14, HY3T77R2, HY3U59R4, HY4A96R3,
HY4B44R, HY4B50R, HY4E05R8, HY4E66R5, HY4V82R2, HY4X31R7, HY4Y15R11, HY4Z59R7,
HY4Z62R5, HY5C74R15, HY5D07R, HY5D70R1, HY5L38R1, HY5N41R2, HY5N42R3, HY5P52R,
HY5Q00R, HY5S13R, HY5S33R2, JP1Z53R11, M310113Q, M310319A, M310523D, M310525C,
M310531G, M310538A, M310543F, M310824V, M310852C, M310854A, M311028K, M311224A,
M311818C, M320234E, M320410V, M320608K, M321014K, M321505L, M322318C, M330112G,
M330344D, M330607H, M332108C, M332607G, M333405W, M333809B, M334007C, M334007C,
M334008D, M334209A, M335615B, M336202V, M337412A, M337414A, M337415A, M337417A,
M337418B, M338001P, M340305C, M340615E, M343105G, M380324D, M390206E, M390322C,
M390508D, M390824C, M391817L, M391817M, M391908B, M392814A, M392815A, M395216B,
M395217B, M395319B, M396010D, M397013G, M397912B, M398309C, M399510A, M399511A,
M410811K, M430737A, M443307B, M443822B, M443823B, M447005R, M460524D, M460530B,
M460531B, M460532B, M462007B, M470233C, M470237C, M470945S, M470945T, M490750B,
M495512K, M580211B, M580416B, M580418E, M720407F, M720409F, M720714C, M720718D,
M720720B, M930401B, M930402B, M960116A, M960119A, M973502E, M973901C, M999308D,
P391401B, TL0A42R21, TL0W56R7, TL1E95R12, TL1J50R3, TL2C82R4, TL2H89R7, TL2J77R,
TL2K45R6, TL2L66R5 TL2L67R, TL2M25R6, TL2P63R1, TL2P93R5, TL2P94R9, TL2R00R3,
TL2R66R, TL2S03R4, TL2S21R1, TL2S24R3, TL2S80R24, TL2S80R30, TL2S80R30,
TL2T46R7, TL2U42R13, TL2U59R, TL2W21R, TL2W22R5, TL2W90R11, TL2Z00R4, TL2Z34R,
TL2Z35R, TL3A08R16, TL3B47R8, TL3C66R4, TL3C69R16, TL3E97R5, TL3E98R7, TL3E99R2,
TL3F17R2, TL3F33R1, TL3G03R2, TL3G89R1, TL3H76R12, TL3H85R1, TL3H86R6, TL3K26R8,
TL3L73R5, TL3M00R7, TL3M35R14, TL3M92R1, TL3N21R3, TL3N58R1, TL3P08R4, TL3P79R8,
TL3R32R4, TL3R79R4, TL3R82R6, TL3R95R3, TL3S25R, TL3S39R3, TL3S63R, TL3T02R2,
TL3T11R11, TL3V10R11, TL3V42R6, TL3X14R3, TL3X14R4, TL3X86R5, TL3Y45R1,
TL3Y70R1, TL3Y77R, TL3Z02R4, TL3Z07R, TL3Z67R4, TL4A55R19, TL4A76R, TL4A98R1,
TL4B15R2, TL4B16R5, TL4C84R, TL4D71R1, TL4E06R1, TL4E30R11, TL4F57R2, TL4F60R,
TL4F71R1, TL4F88R6, TL4F97R7, TL4H65R, TL4H98R1, TL4J16R, TL4J32R10, TL4J96R7,
TL4K33R3, TL4K78R, TL4K84R8, TL4K88R, TL4K93R, TL4K95R3, TL4L34R4, TL4M16R2,
TL4M22R10, TL4M94R5, TL4N20R10, TL4N27R3, TL4N84R, TL4P48R2, TL4P64R4, TL4Q43R3,
TL4Q43R4, TL4R10R2, TL4R21R, TL4S97R8, TL4T06R3, TL4U93R7, TL4V76R1, TL4V77R,
TL4W07R4, TL4W22R, TL4W94R1, TL4X63R1, TL4X99R8, TL4Y20R2, TL4Z28R2, TL5054R11,
TL5263R2, TL5398R19, TL5398R20, TL5A39R3, TL5B82R1, TL5B83R1, TL5C29R2,
TL5C35R6, TL5C63R2, TL5C64R3, TL5C97R6, TL5D45R4, TL5D65R, TL5D66R3, TL5E04R,
TL5E11R1, TL5F48R, TL5F62R5, TL5F64R4, TL5F96R, TL5G03R2, TL5G04R2, TL5G26R1,
TL5G27R, TL5G27R1, TL5G41R2, TL5H55R1, TL5J24R6, TL5J74R2, TL5L27R1, TL5N42R2,
TL5N43R3, TL5N53R1, TL5N59R, TL5N60R, TL5N62R4, TL5N79R, TL5N94R, TL5P14R,
TL5P59R2, TL5P73R2, TL5P76R2, TL5Q40R1, TL5Q76R3, TL5Q85R2, TL5Q89R1, TL5R08R,
TL5R15R2, TL5R18R1, TL5R52R, TL5R57R1, TL5R91R5, TL5S53R, TL5T73R, TL5U33R,
TS1259R14, TS1259R15, TS1366R3, TS1366R4, TS1366R5, TS1404R1, TS1414R3, TS1420R,
TS1423R3, TS1434R, TS1434R1, TS1434R2, TS1441R1, TS1442R1, TS1464R1, TS1470R,
TS1476R, TS1477R3, TS1480R3, TS1480R5, TS1487R, TS1487R1, TS1487R2, TS1489R,
TS1491R, TS8008R26, TS8024R18, TS8040R28, TS8040R29, TS8041R20, TS8041R21,
TS8093R12, TS8148R15, TS8148R16, TS8151R9, TS8163R10, TS8163R11, TS8163R12,
TS8178R8, TS8182R15, TS8183R10, TS8183R9, TS8184R15, TS8184R16, TS8212R5,
TS8212R6, TS8258R2, TS8258R3, TS8267R3, TS8287R3, TS8287R4, TS8296R9, TS8309R4,
TS8309R5, TS8311R1, TS8323R6, TS8328R8, TS8328R9, TS8329R6, TS8339R3, TS8340R6,
TS8345R1, TS8345R2, TS8348R5, TS8348R6, TS8349R7, TS8350R4, TS8350R6, TS8357R2,
TS8357R4, TS8363R3, TS8363R5, TS8376R3, TS8376R4, TS8380R4, TS8380R5, TS8380R6,
TS8381R6, TS8382R5, TS8382R6, TS8387R5, TS8388R3, TS8388R4, TS8390R3, TS8390R4,
TS8390R5, TS9412R4, TS9416R1, TS9416R2, TS9420R4, TS9422R35, TS9423R2, TS9423R3,
TS9425R38, TS9749R27, TS9781R11, TS9781R12, TS9800R30, TS9806R11, TS9807R23,
TS9818R23, TS9818R24, TS9824R16, TS9917R27, TS9950R21, TS9959R12, TS9959R13,
XP41BT, and XP41T,
CODE
MODEL # /
LOT #: 95215/ 9834158, 9836054, 9840678, 9841550, 9841559, 9845071, 9847467,
9850444, 9855692, 9856192, 9862423, 9864967, 9866563, 9868270, 9871572, 9874613,
9875139, 9882831, 9884748, 9889245, 9891467, 9892254, 9918684;
95216/
9842281, 9846078, 9849122, 9851739, 9858463, 9864836, 9870318, 9870329, 9881577,
9885872, 9890513, 9892011, 9895530, 9896568, 9904481, 9905578, 9905755, 9907437,
9911601, 9912191;
95217/ 9837473 9837609, 9837669, 9838938, 9839026,
9842333, 9842382, 9842493, 9844162, 9845850, 9846383, 9847644, 9848942, 9849195,
9849848, 9850346, 9851508, 9852863, 9853060, 9854098, 9856703, 9856833, 9857062,
9858085, 9858293, 9860038, 9861271, 9861502, 9862976, 9863247, 9864837, 9865234,
9865893, 9866024, 9866164, 9868050, 9868760, 9870331, 9870409, 9870650, 9871483,
9872441, 9874427, 9875822, 9877281, 9877367, 9877440, 9877762, 9879316, 9880467,
9880641, 9881610, 9881925, 9881981, 9882840, 9883447, 9883450, 9884377, 9884881,
9886033, 9888892, 9888949, 9888952, 9889923, 9890206, 9891481, 9891930, 9892779,
9894202, 9894438, 9895542, 9895563, 9895750, 9897223, 9897279, 9897429, 9897698,
9898810, 9898944, 9898999, 9900403, 9900493, 9900526, 9900613, 9900980, 9901023,
9901088, 9901471, 9901630, 9901950, 9902927, 9903604, 9904240, 9904417, 9905391,
9905487, 9907004, 9907578, 9907584, 9908483, 9910191, 9910776, 9911401, 9911717,
9912960, 9913072, 9913268, 9920082; 95249/9844242, 9866206, 9875679, 9879355,
9884526, 9899196, 9900455, 9901014, 9901467, 9904646, 9910460, 9918448;
95250/9838923, 9839181, 9845804, 9860022, 9864835, 9868938, 9875809, 9877559,
9880811, 9880821, 9881576, 9889922, 9894165, 9901002, 9903602, 9905673, 9907549,
9907592, 9908172, 9908874, 9913036, 9919854; 95252/9845799, 9907597;
0H46R28/9801904, 9849211, 9874833, 9904051, 9904052; 0M81R41/9856457;
0R35R13/9856482, 9915510; 0Y95R22/9801921; 1702R51/9871082;1A11R16/9864529,
9898363, 9900836; 1A19R26/9871079; 1B22R5/9852609, 9852610, 9876095;
1F66R12/9852612, 9906222; 1G47R4/9859472; 1K86R3/9812743, 9845548;
1K93R5/9823298, 9898343; 1L71R20/9904065; 1M05R12/9882585; 1P07R6/9849635,
9906224, 9909834; 1X24R/9828429, 9882586; 2892R18/9823305;
2D64R12/9849668, 9849669, 9898367; 2E55R9/9842027, 9895126, 9895127;
2N90R8/9898372; 2V85R4/9898358;
3B89R12/9859504; 3C98R7/9849639;
3C98R7/9849640; 3P11R4/9818271, 9894029; 3R39R2/9848260,
9876345, 9911074; 3R42R14/9900843, 9900844; 4B46R16/9849670;
4E58R16/9856481; 4F13R2/9856483; 4J01R7/9891239;
4Q39R1/9864519, 9906234; 4R68R5/9836720; 4R68R6/9906246;
4W65R/9842003; 4X44R7/9866759, 5633R30/9842026, 5C89R2/9845566,
5D83R/9866760, 5R69R1/9875367, 5R69R1/9895326, 5U35R/9929024, 9059R20/9842010,
9059R20/9900837, 9243R19/9845568, 9243R19/9895319, 9243R19/9909937,
CB0A12R15/9818152, CB2T58R4/9869742, CB3L15R5/9853896, CB3L15R5/9904049,
CB4D99R4/9915505, CB4E05R6/9828459, CB4E05R6/9874930, CB4J24R2/9906207,
CB4J67R1/9895280, CB4K47R1/9909756, CB4K64R5/9856461, CB5B53R/9882599,
CB5B53R/9915507, CB5C01R2/9864545, CB5C82R9/9864546, CB5C82R9/9864653,
CB5P29R4/9871450, CB5P29R4/9914212, CB5Q88R/9861123, CB5S97R2/9921078,
DP38T/9874904, DP38T/9904640, HY0W55R17/9808971, HY0W55R17/9910794,
HY0Y86R17/9895142, HY0Y86R17/9895324, HY1709R34/9914044, HY1C73R16/9856469,
HY2F13R22/9836729, HY2F13R23/9916965, HY2J04R2/9856414, HY2K12R5/9900680,
HY2K16R5/9861559, HY2K16R5/9897791, HY2K51R14/9853921, HY2K51R14/9871066,
HY2K51R14/9897797, HY2K60R3/9828457, HY2Q31R1/9856468, HY2Q32R2/9909790,
HY2T49R3/9898330, HY2U43R5/9895125, HY2U98R5/9909926, HY2W85R9/9849675,
HY2W85R9/9849676, HY2W85R9/9849677, HY3B29R13/9895322, HY3C53R1/9871041,
HY3E77R13/9849120, HY3H52R13/9895169, HY3L42R12/9866761, HY3L42R12/9886081,
HY3L78R1/9923377, HY3M41R4/9849658, HY3M43R1/9828413, HY3M45R1/9864484,
HY3Q11R14/9895138, HY3Q11R14/9895139, HY3T77R2/9896464, HY3T77R2/9898435,
HY3U59R4/9865471, HY3U59R4/9923417, HY4A96R3/9828227, HY4B44R/9874912,
HY4B50R/9864521, HY4E05R8/9909957, HY4E66R5/9855421, HY4V82R2/9882601,
HY4X31R7/9914047, HY4Y15R11/9897011, HY4Y15R11/9907958, HY4Z59R7/9902612,
HY4Z62R5/9882303, HY5C74R15/9871083, HY5D07R/9864530, HY5D70R1/9853933,
HY5D70R1/9909930, HY5L38R1/9904073, HY5L38R1/9918472, HY5N41R2/9869677,
HY5N42R3/9900846, HY5P52R/9877621, HY5P52R/9902248, HY5Q00R/9857173,
HY5S13R/9911027, HY5S33R2/9922456, JP1Z53R11/9860355, M310113Q/200986523,
M310113Q/201017351, M310319A/201004514, M310523D/200960594, M310523D/200983800,
M310523D/201014186, M310525C/200776830, M310525C/200914593, M310525C/200999719,
M310531G/200951787, M310538A/200767906, M310538A/200998230, M310543F/200933365,
M310543F/200968691, M310543F/200996499, M310824V/200986605, M310824V/201017488,
M310852C/200946515, M310854A/200946514, M311028K/200937915, M311028K/200971865,
M311028K/201025580, M311224A/200970165, M311224A/200996653, M311818C/200979740,
M320234E/200951680, M320410V/201011466, M320608K/200991864, M320608K/201021498,
M321014K/200995749, M321505L/200973472, M322318C/200945750, M322318C/200973463,
M330112G/200983044, M330344D/200973338, M330607H/200978376, M332108C/201004516,
M332108C/201029676, M332607G/200996493, M333405W/200986410, M333809B/200972405,
M334007C/200926570, M334007C/200974974, M334007C/201033042, M334008D/200962670,
M334008D/200978372, M334209A/200974961, M334209A/200984671, M334209A/201016613,
M335615B/200995752, M336202V/200978364, M336202V/201011474, M337412A/200962585,
M337412A/201017359, M337414A/200962660, M337414A/201020119, M337414A/201029347,
M337415A/200950040, M337415A/200977462, M337417A/200984626, M337418B/200984630,
M337418B/201016607, M338001P/200981099, M338001P/201024768, M340305C/200936579,
M340615E/200972408, M343105G/200979741, M380324D/200978556, M380324D/201012978,
M390206E/200948497, M390206E/200973465, M390322C/200957117, M390508D/200971872,
M390824C/200933406, M390824C/201017510, M391817L/200948854, M391817M/200974967,
M391908B/200945741, M391908B/200990138, M392814A/200977455, M392814A/201001630,
M392814A/201034510, M392815A/200950055, M395216B/200962721, M395216B/200985176,
M395217B/200933306, M395217B/200971868, M395319B/200973265, M396010D/200970167,
M397013G/200950190, M397013G/201001823, M397912B/200935634, M397912B/201049318,
M398309C/200984061, M398309C/201014558, M399510A/200975056, M399511A/200964869,
M399511A/201017354, M410811K/200935071, M410811L/200977489, M430737A/200973327,
M430737A/201054543, M443307B/201039509, M443822B/200976415, M443822B/201054699,
M443823B/200976416, M443823B/201054695, M447005R/200978551, M460524D/200949744,
M460530B/200949742, M460530B/200966981, M460531B/200999992, M460532B/200926957,
M460532B/200966932, M460532B/200999981, M462007B/200991873, M462007B/201021499,
M470233C/200974975, M470233C/201029764, M470237C/200975131, M470945S/200933318,
M470945S/200971849, M470945T/201001926, M490750B/200938518, M495512K/200987075,
M495512K/201004645, M580211B/200957101, M580211B/201036281, M580416B/200945726,
M580416B/201024718, M580418E/200983048, M720407F/200968561, M720409F/200938479,
M720409F/200974976, M720714C/200938466, M720714C/200973329, M720714C/201001639,
M720718D/200968698, M720718D/200973667, M720720B/200964933, M930401B/200922137,
M930402B/200922135, M960116A/200979559, M960119A/200979558, M973502E/200984001,
M973502E/201013844, M973901C/200813720, M999308D/200948517, M999308D/200974969,
P391401B/200953133, P391401B/201054693, TL0A42R21/9882593, TL0W56R7/9868069,
TL1E95R12/9909898, TL1J50R3/9658714, TL2C82R4/9923403, TL2H89R7/9898365,
TL2J77R/9841963, TL2K45R6/9845562, TL2K45R6/9900831, TL2L66R5/9895285,
TL2L66R5/9909791, TL2L67R/9898332, TL2M25R6/9854038, TL2P63R1/9856415,
TL2P93R5/9904074, TL2P94R9/9906240, TL2R00R3/9856416, TL2R00R3/9909792,
TL2R66R/9874913, TL2S03R4/9906233, TL2S03R4/9909890, TL2S21R1/9836684,
TL2S24R3/9874935, TL2S80R24/9853927, TL2S80R30/9868071, TL2S80R30/9885490,
TL2S80R30/9897798, TL2T46R7/9915448, TL2U42R13/9849687, TL2U42R13/9898371,
TL2U59R/9895286, TL2W21R/9849620, TL2W22R5/9923378, TL2W90R11/9879897,
TL2Z00R4/9895111, TL2Z34R/9909795, TL2Z35R/9915484, TL3A08R16/9891237,
TL3B47R8/9841965, TL3C66R4/9864486, TL3C66R4/9864487, TL3C69R16/9828450,
TL3E97R5/9845541, TL3E98R7/9921079, TL3E99R2/9885607, TL3F17R2/9898451,
TL3F33R1/9919253, TL3G03R2/9871067, TL3G89R1/9593332, TL3G89R1/9898334,
TL3H76R12/9846723, TL3H85R1/9891217, TL3H86R6/9911088, TL3K26R8/9809022,
TL3L73R5/9895287, TL3L73R5/9923379, TL3M00R7/9879882, TL3M35R14/9863156,
TL3M35R14/9868110, TL3M92R1/9911060, TL3N21R3/9864488, TL3N58R1/9926687,
TL3P08R4/9849753, TL3P08R4/9923415, TL3P79R8/9875092, TL3P79R8/9910788,
TL3R32R4/9808976, TL3R32R4/9871042, TL3R79R4/9887326, TL3R82R6/9856417,
TL3R82R6/9856418, TL3R95R3/9915500, TL3S25R/9887067, TL3S39R3/9925910,
TL3S63R/9898336, TL3T02R2/9812851, TL3T11R11/9900024, TL3T11R11/9900024,
TL3V10R11/9874853, TL3V42R6/9904031, TL3V42R6/9914075, TL3V42R6/9919254,
TL3X14R3/9856420, TL3X14R4/9909961, TL3X86R5/9906215, TL3Y45R1/9881136,
TL3Y45R1/9891218, TL3Y70R1/9924750, TL3Y77R/9864490, TL3Y77R/9898337,
TL3Y77R/9900811, TL3Z02R4/9887333, TL3Z07R/9852606, TL3Z07R/9895270,
TL3Z67R4/9845542, TL4A55R19/9874941, TL4A76R/9866737, TL4A98R1/9856421,
TL4A98R1/9856422, TL4A98R1/9909804, TL4B15R2/9818238, TL4B16R5/9859493,
TL4C84R/9859466, TL4D71R1/9895289, TL4E06R1/9904071, TL4E30R11/9879885,
TL4F57R2/9919260, TL4F60R/9834322, TL4F71R1/9859497, TL4F71R1/9891235,
TL4F88R6/9871078, TL4F97R7/9864517, TL4H65R/9885464, TL4H65R/9909805,
TL4H98R1/9909892, TL4J16R/9909806, TL4J32R10/9845571, TL4J32R10/9906244,
TL4J32R10/9909956, TL4J96R7/9895309, TL4J96R7/9906235, TL4J96R7/9909902,
TL4K33R3/9864974, TL4K33R3/9883915, TL4K33R3/9895124, TL4K33R3/9929052,
TL4K78R/9914187, TL4K84R8/9911087, TL4K88R/9856456, TL4K93R/9895307,
TL4K93R/9909889, TL4K95R3/9874933, TL4L34R4/9930801, TL4M16R2/9841994,
TL4M16R2/9841995, TL4M16R2/9911076, TL4M22R10/9859501, TL4M94R5/9854039,
TL4N20R10/9896593, TL4N27R3/9871071, TL4N84R/9849655, TL4N84R/9909908,
TL4P48R2/9895320, TL4P64R4/9849671, TL4P64R4/9907954, TL4Q43R3/9852368,
TL4Q43R4/9898373, TL4R10R2/9845570, TL4R10R2/9879894, TL4R21R/9914198,
TL4R21R/9931609, TL4S97R8/9859509, TL4T06R3/9871074, TL4U93R7/9911026,
TL4V76R1/9923408, TL4V77R/9903794, TL4W07R4/9913292, TL4W22R/9871068,
TL4W22R/9895313, TL4W94R1/9900834, TL4X63R1/9882598, TL4X99R8/9852634,
TL4Y20R2/9895131, TL4Z28R2/9885485, TL4Z28R2/9887337, TL4Z28R2/9909940,
TL5054R11/9856424, TL5263R2/9909906, TL5398R19/9843924, TL5398R20/9895328,
TL5A39R3/9864541, TL5B82R1/9849665, TL5B82R1/9859499, TL5B82R1/9879887,
TL5B83R1/9859500, TL5B83R1/9879888, TL5C29R2/9866092, TL5C29R2/9916514,
TL5C35R6/9900842, TL5C63R2/9841958, TL5C63R2/9859389, TL5C63R2/9862430,
TL5C63R2/9915511, TL5C64R3/9904062, TL5C97R6/9895137, TL5D45R4/9871075,
TL5D65R/9890576, TL5D66R3/9834377, TL5D66R3/9859510, TL5D66R3/9859511,
TL5D66R3/9927936, TL5E04R/9911079, TL5E04R/9929680, TL5E11R1/9921081,
TL5F48R/9836721, TL5F48R/9900839, TL5F62R5/9896938, TL5F64R4/9896939,
TL5F96R/9896940, TL5G03R2/9896941, TL5G04R2/9896942, TL5G26R1/9931614,
TL5G27R/9893749, TL5G27R1/9910921, TL5G41R2/9879902, TL5H55R1/9858542,
TL5H55R1/9885489, TL5J24R6/9868594, TL5J24R6/9870786, TL5J74R2/9891246,
TL5J74R2/9904064, TL5L27R1/9828462, TL5N42R2/9869678, TL5N43R3/9865432,
TL5N43R3/9914137, TL5N53R1/9921857, TL5N59R/9869738, TL5N60R/9869785,
TL5N60R/9926703, TL5N62R4/9864809, TL5N62R4/9887341, TL5N62R4/9894785,
TL5N79R/9911085, TL5N94R/9874148, TL5P14R/9883936, TL5P59R2/9896929;
TL5P73R2/9925064; TL5P76R2/9932315, TL5Q40R1/9879468; TL5Q76R3/9930859, 9932577;
TL5Q85R2/9913293, TL5Q89R1/9892383, 9926708; TL5R08R/9875101; TL5R15R2/9878911;
TL5R18R1/9923206; TL5R52R/9894022; TL5R57R1/9918893; TL5R91R5/9918898, 9931616;
TL5S53R/9892387, 9910061, 9918921; TL5U33R/9932314; TS1259R14/0000678918,
0000680574, 0000698748; TS1259R15/0000717577; TS1366R3/0000666582, 0000666584;
TS1366R4/0000674278, 0000674279, 0000676748, 0000690365, 0000690367, 000711275,
0000711278, 0000711281, 0000714758, 0000714759; TS1366R5/0000679864, 0000679865,
0000679877, 0000679878, 0000680617, 0000683344, 0000683365, 0000685091,
0000685092, 0000687732, 0000687733, 0000693076, 0000693081, 0000694811,
0000697858, 0000697859, 0000699550, 0000699552, 0000703198, 0000704023,
0000705433, 0000705434, 0000709159, 0000709160, 0000717459, 0000717579,
0000721710, 0000721714, 0000724038, 0000724040, 0000727453; TS1404R1/0000702270,
0000706954, 0000713786, 0000714751, 0000717143, 0000717431, 0000720102,
0000721485; TS1405R1/0000725135, 0000727254; TS1406R1/0000708248;
TS1414R3/0000694899; TS1420R/0000671368, 0000676756, 0000679997, 0000680698,
0000686918, 0000689296, 0000689303, 0000690357, 0000700945, 0000704416,
0000704575, 0000707196, 0000708343, 0000712408, 0000716405, 0000720477,
0000724108, 0000727448; TS1423R3/0000672120, 0000674975, 0000676009, 0000683458,
0000692018, 0000697723, 0000697734, 0000700801, 0000704367, 0000707214,
0000720398, 0000727391; TS1434R/0000687709, 0000692805, 0000699993, 0000712504,
0000725183; TS1434R1/0000717260, 0000717582, 0000718578, 0000721812;
TS1434R2/0000678999, 0000681548, 0000687716, 0000712336, 0000714756, 0000723102,
0000723732, 0000725187, 0000727458, TS1436R2/0000677992; TS1436R2/0000698843,
0000720585; TS1441R1/0000679020, 0000693083, 0000701007, 0000714931, 0000725137;
TS1442R1/0000703329, 0000704007; TS1464R1/0000674905, 0000700813;
TS1470R/0000664062, 0000676148, 0000676810, 0000678000, 0000689134, /0000692914,
0000692981, 0000694076, 0000710419, 0000691107; TS1476R/0000705312, 0000711280,
0000721321; TS1477R3/0000664920; TS1480R3/0000682643; TS1480R5/0000682651,
0000685096, 0000689355, 0000698716, 0000704319, 0000710146, 0000716164;
TS1487R/0000663088, 0000666583, 0000666630, 0000678776, 0000678783, 0000678801;
TS1487R1/0000687729, 0000687731, 0000690238, 0000691281, 0000692990, 0000697608,
0000717379; TS1487R2/0000699592, 0000706950, 0000708267, 0000712299, 0000713681,
0000721526; TS1489R/0000718453; TS1491R/0000685752, 0000685754;
TS8008R26/0000675071, 0000708169, 0000714871; TS8024R18/0000705493;
TS8040R28/0000666588, 0000674368, 0000676750; TS8040R29/0000672038, 0000679875,
0000683433, 0000685093, 0000690113, 0000690366, 0000693079, 0000694813,
0000697860, 0000699551, 0000703230, 0000705431, 0000709006, 0000711274,
0000714757, 0000717461, 0000721712, 0000724041; TS8041R20/0000678901,
0000680561; TS8041R21/0000689220; TS8093R12/0000713994; TS8148R15/0000687704;
TS8148R16/0000689307, 0000695319, 0000711323, 0000712300, 0000713895,
0000718475, 0000722562; TS8151R9/0000673946, 0000677841, 0000685846, 0000690190,
0000692240, 0000696181, 0000705370, 0000711440, /0000718570, 0000722592;
TS8163R10/0000665624, 0000666650; TS8163R11/0000672251, 0000672834, 0000676653,
0000679964, 0000682493, 0000685839; TS8163R12/0000689004, 0000689978,
0000690490, 0000692238, 0000696205, 0000697740, 0000702224, 0000707102,
0000708272, 0000709201, 0000711251, 0000717014, 0000717015, 0000722920,
0000724873; TS8178R8/0000676646, 0000684077, /0000686010, 0000689240;
TS8182R15/0000685793, 0000686030, 0000704422; TS8183R10/0000676650, 0000681387,
0000686020, 0000693138, 0000697660, 0000703123, 0000707104, 0000709012,
0000712314, 0000718376, 0000722940, 0000725096, 0000726183; TS8183R9/0000672138,
0000673930; TS8184R15/0000672061, TS8184R15/0000673924; TS8184R16/0000684081,
0000684083, 0000685763, 0000687711, 0000690156, 0000692966, 0000696108,
0000700721, 0000707030, 0000708997, 0000712312, 0000718372, 0000724871;
TS8212R5/0000667107, 0000672190, 0000673921, 0000675074, 0000677755, 0000679826,
0000680582, 0000683308, 0000684936; TS8212R6/0000687727, 0000689379, 0000691242,
0000692012, 0000693784, 0000699591, 0000700636, 0000704357, 0000705311,
0000707975, 0000711462, 0000714659, 0000717141, 0000720220, 0000722455,
0000726154, 0000727385; TS8258R2/0000686006; TS8258R3/0000675072, 0000696184,
0000702234; TS8267R3/0000690451; TS8267R4/0000711409; TS8287R3/0000665661,
0000673927; TS8287R4/0000686951, 0000692017, 0000703002, 0000713560, 0000720183;
TS8296R9/0000689212, 0000694040, 0000700867, 0000712412, 0000713824;
TS8309R4/0000667327, TS8309R5/0000676110, 0000684159, 0000691354, 0000699633,
0000709010, 0000715985, 0000721464; TS8311R1/0000685019, 0000721524, 0000722574;
TS8323R6/0000686933, 0000708172; TS8328R8/0000675082, 0000676691, 0000677937,
0000681483, 0000681485, 0000684167, 0000685857, 0000686930, 0000704402,
0000708271; TS8328R9/0000716362, 0000718476; TS8329R6/0000675972,
0000678643, 0000682496, 0000690153, 0000694609, 0000698829, 0000713937,
0000720242, 0000727366; TS8339R3/0000685016, 0000709246, 0000714930, 0000720450;
TS8340R6/0000678804, 0000691166, 0000718471, 0000726245,
TS8345R1/0000665622; TS8345R2/0000682432, 0000697658, 0000713763;
TS8348R5/0000672917; TS8348R6/0000679862, 0000692188, 0000693951, 0000700637,
0000702900, 0000708230, 0000711369, 0000714782, 0000720328, 0000726226,
0000727365; TS8349R7/0000685097, 0000713789; TS8350R4/0000666627,
0000674282; TS8350R6/0000678857, 0000685025, 0000707078, 0000711382, 0000718473,
0000725003; TS8357R2/0000674242; TS8357R4/0000677770, 0000679825, 0000693921,
0000714008, 0000723733, 0000724050; TS8363R3/0000685840, 0000716000;
TS8363R5/0000689009, 0000694043, 0000722560, 0000723918; TS8365R5/0000681505,
0000689964, 0000712247, 0000713977; TS8376R3/0000685786, 0000685788, 0000690097;
TS8376R4/0000695350, 0000695356, 0000698742, 0000708404, 0000708405, 0000716494,
0000716498, 0000721487, 0000724870; TS8380R4/0000672239, 0000675975, 0000680565,
0000684934, 0000685790; TS8380R5/0000687712, 0000688054, 0000688084, 0000693074,
0000694815, 0000696107, 0000700717, 0000703228; TS8380R6/0000704550, 0000708944,
0000712517, 0000718406, 0000721782, 0000683469, 0000683470, 0000687082,
0000691322, 0000692011, 0000701974, 0000720415, 0000723734, 000725138;
TS8382R5/0000674951, 0000685844; TS8382R6/0000691102, 0000699992,
0000704356, 0000710029, 0000716017; TS8387R5/0000672198, 0000678739, 0000682603,
0000687077, 0000687868, 0000693054, 0000694123, 0000708408, 0000714897,
0000720194, 0000727368; TS8388R3/0000662094, 0000662908, 0000663937, 0000664737,
0000665616, 0000666464, 0000667103, 0000670937, 0000672282, 0000672916,
0000675107, 0000675976, 0000677752, 0000677759, 0000683314; TS8388R4/0000679863,
0000680660, 0000680793, 0000681468, 0000682586, 0000685070, 0000685755,
0000685761, 0000687710, 0000688985, 0000689006, 0000690154, 0000691109,
0000692110, 0000692964, 0000694600, 0000694812, 0000696192, 0000698353,
0000699548, 0000700720, 0000701976, 0000703005, 0000704024, 0000705314,
0000707032, 0000708114, 0000709031, 0000710369, 0000711245, 0000712246,
0000713766, 0000714784, 0000716292, 0000718393, 0000720218, 0000721463,
0000724872, 0000727255; TS8390R3/0000667287, 0000671481; TS8390R4/0000693263;
TS8390R5/0000702343, 0000725136; TS8397R5/0000725229; TS9412R4/0000680661,
0000686889, 0000700908, 0000700973, 0000704567, 0000715042, 0000721788;
TS9416R1/0000666539; TS9416R2/0000676111, 0000689000, 0000696021, 0000709244,
0000711304, 0000721652, 0000723021; TS9420R4/0000724092; TS9422R35/0000673932,
0000677981, 0000683408, 0000688056, 0000690443, 0000698349, 0000699661,
0000702214, 0000709158, 0000713968, 0000726432, 0000727315; TS9423R2/0000666496,
0000686906; TS9423R3/0000674357, 0000682606, 0000693024, 0000696183, 0000703124,
0000724042; TS9425R38/0000675106, 0000687713, 0000687714, 0000696016,
0000705319, 0000707057, 0000716291, 0000726244; TS9749R27/0000680595,
0000683301, 0000690189, 0000695318, 0000699634, 0000712301, 0000713764,
0000716440, 0000720350, 0000724869, 0000726185; TS9781R11/0000665814;
TS9781R12/0000676648, 0000681386, 0000691170, 0000700771, 0000711279,
0000725107; TS9800R30/0000674358, 0000674384, 0000675218, 0000681373,
0000685110, 0000690494, 0000701004, 0000711333, 0000721759;
TS9806R11/0000665848, 0000667330, 0000673003; TS9807R23/0000683377, 0000685753,
0000692010, 0000700929, 0000712471, 0000725186; TS9818R23/000066738;
TS9818R24/0000680577, 0000684938, 0000692020, 0000712468, 0000725015;
TS9824R16/0000712413, 0000723728, 0000725097; TS9917R27/0000662927;
TS9950R21/0000675998, 0000685758, 0000698361, 0000717504; TS9959R12/0000662196,
0000673917, 0000683368, 0000689970; TS9959R13/0000693279, 0000697811,
0000707165, 0000710353, 0000723942; XP41BT/9904032; XP41T/9866739,
9874914
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Medtronic International Trade Inc, Brooklyn Park, MN,
Manufacturer: Medtronic Mexico, S.
De R. L. De C.V, Tijuana, Baja California, Mexico.
REASON
Medtronic is advising that certain
Trillium-coated Medtronic cardiopulmonary bypass (CBP) products (e.g.,
oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin
batches contaminated with oversulfated chondroitin sulfate (OSCS). Based upon
currently available information, Medtronic has determined that Medtronic
Trillium-coated products can continue to be used in cardiopulmonary bypass
procedures. Medtronic's heparin supplier recently reported that it had provided
some batches of heparin to Medtronic which were contaminated with OSCS.
Medtronic has no evidence linking the use of Trillium-coated CPB products to
OSCS related adverse events. Customers were informed of this because OSCS is not
intended to be a component material of Trillium Coating and because OSCS has
been reported to cause patient adverse events when injectable formulations of
contaminated heparin are given in sufficient doses.
VOLUME OF PRODUCT
IN COMMERCE 59,500
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Cytomics FC 500 Flow Cytometry System with CXP Software Version
2.1 and 2.2 - FC 500 with UPS, Automated differential
cell counter; Part Number: 626553;
b) Cytomics FC 500 Flow Cytometry System with CXP Software
Version 2.1 and 2.2 - FC 500 120V, Automated differential
cell counter; Part Number 6605628;
c) Cytomics FC 500 Flow Cytometry System with CXP Software
Version 2.1 and 2.2 - CXP analysis SW V2.1 single user,
Automated differential cell counter; Part Number 722396; d) Cytomics FC 500 Flow Cytometry System with CXP
Software Version 2.1 and 2.2 - CXP analysis SW V2.1
single user upgrade, Automated differential cell counter;
Part Number 722395; R
e) Cytomics FC 500 Flow Cytometry
System with CXP Software Version 2.1 and 2.2 - CXP
analysis SW V2.1, 3 User Pack, Automated differential cell counter; Part Number 722397;
f)
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 5 User Pack, Automated
differential cell counter; Part Number 722398;
g) Cytomics FC 500 Flow Cytometry System with CXP Software
Version 2.1 and 2.2 - CXP analysis SW V2.1, 15 User Pack,
Automated differential cell counter; Part Number 722399;
h) Cytomics FC 500 Flow Cytometry System with CXP
Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 5
network user with Romlock, Automated differential cell
counter; Part Number 722593;
i) Cytomics FC 500 Flow
Cytometry System with CXP Software Version 2.1 and 2.2 -
CXP analysis SW V2.1, 10 network user with Romlock, Automated differential cell counter; Part Number 722594;
j) Cytomics FC 500 Flow Cytometry System with CXP Software
Version 2.1 and 2.2 - CXP analysis SW V2.1, 15 network
user with Romlock, Automated differential cell counter;
Part Number 722595;
k) Cytomics FC 500 Flow Cytometry
System with CXP Software Version 2.1 and 2.2 - SW Kit,
CXP Analyis SW V2.2 Single User, Automated differential
cell counter; Part Number 774197;
l) Cytomics FC 500
Flow Cytometry System with CXP Software Version 2.1 and
2.2 - SW Kit, CXP Analyis SW V2.2 Single User Upgrade, Automated differential cell counter; Part Number 774198;
m) Cytomics FC 500 Flow Cytometry System with CXP Software
Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 3
User, Automated differential cell counter; Part Number
774199;
n) Cytomics FC 500 Flow Cytometry System with
CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW
V2.2, 5 User, Automated differential cell counter; Part
Number 774200;
o) Cytomics FC 500 Flow Cytometry System
with CXP Software Version 2.1 and 2.2 - SW Kit, CXP
Analyis SW V2.2, 15 User, Automated differential cell
counter; Part Number 774201;
p) Cytomics FC 500 Flow
Cytometry System with CXP Software Version 2.1 and 2.2 -
SW Kit, CXP Analyis SW V2.2, 5 User Network, Automated
differential cell counter; Part Number 774178;
q)
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 10 User Network,
Automated differential cell counter; Part Number 774179;
r) Cytomics FC 500 Flow Cytometry System with CXP
Software Version 2.1 and 2.2 - SW Kit, CXP Analyis
SW V2.2, 15 User Network, Automated differential cell
counter; Part Number 774180;
CODE Version 2.1 and 2.2
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: Applied
Cytometry, Sheffield,
United Kingdom.
REASON Incorrect Display: In certain modes, the protocol
will not initially display the correct data in some plots. In addition, when
running EWL files, any edited SampleID1 is not automatically updated in all
tubes in the panel.
VOLUME OF PRODUCT IN COMMERCE 501
units
DISTRIBUTION Nationwide and Canada
PRODUCT EUB-5500
VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging
device intended to provide the physician with physiological and clinical
information,
CODE
Serial Numbers:
11743701 to 11743705 11837701 to 11837705 11906701 to 11906705 12006701 to
12006710 12124701 to 12124710 12315701 to 12315705 12427801 to
12427805
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Hitachi Medical Systems America Inc, Twinsburg, OH,
Manufacturer: Hitachi Medical Corporation,
Chiyoda-Ku, Tokyo, Japan.
REASON Miscalculation reading. A software error in the
firm's EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of
the left ICA/CCA ratio when using the Carotid Calculation package for patient
scans.
VOLUME OF PRODUCT IN COMMERCE 20
units
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 9
PRODUCT Precision
500D Classical R&F System with control room PC; Image-intensified
fluoroscopic x-ray system; Model Number: 5117866-27,
CODE
Code Numbers: 00000003712M37
00000004383M36 00000004912M32 00000004207M37 00000003989M31 00000004669M38
00000004911M34 00000003192M32 00000003711M39 00000004391M39 00000003988M33
00000003101M33 00000003986M37 00000003899M32 00000003916M34 00000003991M37
00000003893M35 00000004385M31 00000003190M36 00000004208M35 00000003716M38
00000003918M30 00000003922M32 00000004577M33 00000004572M34 00000003792M39
00000004392M37 00000004388M35 00000004659M39 00000003407M34 00000004209M33
00000003992M35 00000004575M37 00000004579M39 00000003897M36 00000003913M31
00000004782M39 00000003404M31 00000003915M36 00000004389M33 00000003719M32
00000004660M37 00000004780M33 00000004212M37 00000004384M34 00000003896M38
00000003921M34 00000004386M39 00000003226M38 00000003224M33 00000003412M34
00000003386M30 00000004206M39 00000004215M30 00000003189M38 00000004781M31
00000003892M37 00000003713M35 00000004663M31 00000003715M30 00000003227M36
00000004665M36 00000003409M30 00000004787M38 00000003229M32 00000004416M34
00000003403M33 00000004786M30 00000003191M34 00000004578M31 00000004390M31
00000004785M32 00000003408M32 00000003987M35 00000004661M35 00000003894M33
00000003900M38 00000003383M37 00000004662M33 00000003793M37 00000004664M39
00000004909M38 00000003406M36 00000003901M36 00000003405M38 00000003895M30
00000003710M31 00000003717M36 00000004913M30 00000003898M34 00000004170M37
00000003718M34 00000003411M36 00000003919M38 00000003102M31 00000003225M30
00000003384M35 00000003387M38 00000003794M35 00000003917M32 00000003920M36
00000004213M35 00000004415M36 00000004417M32 00000004581M35 00000004666M34
00000004789M34 00000004916M33 00000004999M39 00000005000M35 00000005063M33
00000005064M31 00001009888WK7 00000003990M39 00000004210M31 00000004214M33
00000003993M33 00000004181M34 00000004414M39 00000004418M30 00000004574M30
00000004667M32 00000004668M30 00000004670M36 00000004784M35 00000004788M36
00000004910M36 00000005001M33 and 00000005070M38.
RECALLING
FIRM/MANUFACTURER GE Healthcare, Waukesha, WI,
REASON
Inaccurate cassette size display
reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger
film cassette is inserted into the table Bucky (replacing a smaller cassette)
after a protocol is selected on the console, the collimator will not adjust to
the larger cassette size. The collimator stays at the original smaller cassette
size and allows the operator to take an exposure. 2. The light X-ray film may
report higher than actual mAs readings, than what was actually exposed to the
patient.
VOLUME OF PRODUCT IN COMMERCE 101
systems
DISTRIBUTION Nationwide and
Internationally
PRODUCT Steris C1160 Universal Flexible Processing Tray, for use with
STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes,
CODE
All codes
RECALLING
FIRM/MANUFACTURER Steris Corp., Mentor, OH,
REASON Failure
to effectively sterilize: Under certain conditions, the design/operation of the
C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly
assess the state of the high pressure pump during the Sterile Cycle. The L6
sensor fails to alarm when the high pressure pump is not working
properly.
VOLUME OF PRODUCT IN COMMERCE 28,766
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood
Flow and Intracranial Pressure Monitoring Kit,
CODE Lot: 100063, all serial
numbers
RECALLING FIRM/MANUFACTURER Integra Neuro
Sciences, San Diego, CA,
REASON Incorrect pressure reading: Due to a
manufacturing error, the ICP reading could be inaccurate to the extent that they
exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg
could be exceeded by up to -3mmHg, that could result in a maximum Insertion
Error of +/- 6mmHg.
VOLUME OF PRODUCT IN COMMERCE 43
units
DISTRIBUTION CA, GA, NM, TX, NE, WA,
NY
PRODUCT
a)
International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220. Note:w The AVOXimeter
1000 was discontinued in 1996 by the company which which
ITC acquired the product line from (AVOX Systems in Texas). Today, only service is offered on this mode,
b) International Technidyne Corp. (ITC) AVOXimeter 1000E
Oximeter, Catalog Numbers: AVOX1000E-110 and
AVOX1000E-220,
c) International Technidyne Corp. (ITC)
AVOXimeter 4000 Co-oximeter, Catalog Numbers:
AVOX4000-110 and AVOX4000-220,
CODE
a) Serial Numbers: 1073, 1085, 1197,
1245, 1321, 1383, 1162;
b) Serial Numbers: 1482 1531 1627 1633 1635
1707 1708 1716 1740 1804 1864 1961 1968 1991 1997 2002
2082 2094 2109 2148 2157 2164 2212 2238 2271 2282 2315 2319
2331 2384 2388 2394 2395 2449 2585 2596 2598 2633 2657
2669 2686 2689 2775 2776 2777 2725 2728 2732 2741 2742
2743 2744 2746 2747 2748 2749 2750 2751 2752 2753 2754
2755 2756 2757 2758 2759 2760 2761 2762 2763 2764 2765 2766 2767 2769 2771 2772
2773 2774 2778 2779 2780 2794 2806 2807 2808 2810 2812
2813 2814 2815 2816 2817 2818 2819 2820 2821 2822 2823
2824 2825 2826 2827 2828 2831 2832 2833 2834 2835 2836
2837 2839 2843 2844 2845 2846 2848 2849 2850 2851 2852 2853 2854 2855 2856 2857 2858 2859 2860 2861 2863
2864 2865 2866 2867 2868 2869 2870 2871 2872 2873 2874
2875 2876 2877 2878 2879 2880 2881 2882 2883 2884 2885 2887 2888 2889 2890
2891 2892 2894 2895 2896 2898 2899 2900 2901 2902 2903
2904 2905 2906 2907 2908 2909 2910 2912 2913 2914 2915
2917 2918 2921 2922 2924 2925 2926 2927 2928 2929 2932
2933 2934 2935 2936 2937 2938 2939 2940 2942 2943 2944 2945 2946 2947 2948
2950;
c) Serial Numbers: 41018 41068 41096 41124 41146 41175 41280 41323
41325 41384 41423 41430 41453 41480 41484 41489 41505
41506 41532 41533 41555 41560 41566 41570 41571 41572
41573 41574 41575 41576 41577 41578 41579 41580 41581 41582 41583 41584 41585 41586 41588 41589 41592 41593 41594 41595
41601 41605 41607 41608 41609 41610 41611 41612 41613
41614 41615 41616 41617 41618 41619 41620 41632 41633
41634 41635 41636 41637 41638 41639 Q-1034
RECALLING
FIRM/MANUFACTURER International Technidyne Corp., Edison, NJ,
REASON Incorrect reading: ITC discovered that
instruments built or repaired since approximately April 2007 were inadvertently
left with the diagnostic mode enabled when shipped to
customers.
VOLUME OF PRODUCT IN COMMERCE 273
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Da Vinci S 8mm Instrument Cannula with outlet for use with the Da
Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in
endoscopic surgery to establish a port of entry for Intuitive Surgical's
EndoWrist Instruments,
CODE Lot Numbers: 13730-01-70807,
13793-71106, 13730-02-70807, WI073202, WI074501, WI073201
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Intuitive
Surgical, Inc., Sunnyvale, CA,
Manufacturer: Wightman Engineering Services, Santa
Clara, CA.
REASON
(1) Incorrect dimension on Luer on smoke
evacuation cannulae not allowing for secure attachment function. (2) Incorrect
labeling. External labeling lot number differs from lot number etched on the
cannula.
VOLUME OF PRODUCT IN COMMERCE 39
units
DISTRIBUTION Nationwide
PRODUCT High-Definition 120 MultiLeaf Collimator, Medical charged-particle
radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to
Medical Linear Accelerator,
CODE Serial number: 1009
RECALLING
FIRM/MANUFACTURER Varian Medical Systems Oncology Systems, Palo
Alto, CA,
REASON Dose Calculation Error: Software anomaly
may result in failure of a MLC leaf to reach planned position, potentially
resulting in misadministration of dose to a patient.
VOLUME OF
PRODUCT IN COMMERCE 3
systems
DISTRIBUTION Nationwide
PRODUCT Acuity with Conebeam Computed
Tomography; Radiation therapy
simulation system; Model Number: H77, CODE Serial Numbers: H770002-H780001,
H770012-H780058, H770030-H780034, H770055-H780046, H770068-H780010,
H770107-H780050, H770113-H780060, H770119-H780035, H770134-H780026,
H770143-H780039, H770159-H780062, H770170-H780056, H770184-H780061,
H770212-H780074, H770245-H780086 and H770279-H780105
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems Oncology
Systems, Palo Alto, CA,
Manufacturer: Varian
Medical Systems U.K. Ltd., Crawley, UK.
REASON Incorrect Image Orientation: The image
orientation tag may not be set correctly if the patient has been scanned with an
orientation other than Head First Spine. When such images are imported to a
treatment planning system, they may appear with either a mirrored or a rotated
view.
VOLUME OF PRODUCT IN COMMERCE 16
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Stryker Peek Intraline Anchor, 5.5 mm, Model number
3910-400-010, Used for tissue fixation to bone in certain
areas,
b) Stryker Peek Intraline Anchor, 5.5 mm with
Needles, Model number 3910-400-015, Used for tissue
fixation to bone in certain areas,
c) Stryker Peek
Intraline Anchor, 6.5 mm, Model number 3910-400-020, Used
for tissue fixation to bone in certain areas,
d)
Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025, Used for tissue fixation to bone in certain areas,
e) Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm,
Model number 3910-100-135. Intended for use in securing
soft tissue to bone in certain procedures in specific areas,
f) Stryker Wedge HS Suture
Anchor II with Needles, 6.5 mm, Model number 3910-100-145. Intended for use in securing soft tissue to bone in
certain procedures in specific areas,
CODE
a) Lot numbers 07276AE2, 07295AE2,
07296AE2, 07299AE2, 07312AE2;
b) Lot numbers 07277AE2, 07292AE2, 07295AE2,
07337AE2;
c) Lot numbers 07276AE2, 07299AE2, 07311AE2;
d) Lot numbers
07277AE2, 07292AE2;
e) Lot number 07298AE2, 07299AE2;
f) Lot Numbers
07299AE2
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Stryker Endoscopy, San Jose, CA,
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR.
REASON
Product package may crack and
cause loss of sterility.
VOLUME OF PRODUCT IN
COMMERCE 927 units
DISTRIBUTION CA, OH, PA,
CO, MA, and NJ
PRODUCT
a) Zimmer Dermacarriers II skin graft carriers, 1.5 to 1
dermacarrier, Rx, latex free, sterile, REF
00-2195-012-00. Single use device for use during skin grafting procedures,
b) Zimmer Dermacarriers II skin
graft carriers, 3 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, REF 00-2195-013-00. Single use device for use
during skin grafting procedures,
c) Zimmer Dermacarriers II skin graft carriers, 6 to 1
dermacarrier, Rx, latex free, sterile, Qty 1, REF
00-2195-014-00. Single use device for use during skin grafting procedures,
d) Zimmer Dermacarriers II skin
graft carriers, 9 to 1 dermacarrier, Rx, latex free, sterile, Qty 1; REF 00-2195-015-00. Single use device for use during skin
grafting procedures,
e) Zimmer
Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free,
sterile; REF 00-7708-000-10. Single use device for use
during skin grafting procedures,
f) Zimmer Dermacarriers Skin
Graft Carriers, S.G. Carrier 16IN length, Rx, latex free, sterile; REF 00-7716-000-10. Single use device for use during skin
grafting procedures, CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer,
Inc., Warsaw, IN,
Manufacturer: Zimmer
Orthopedic Surgical Products, Dover, OH.
REASON Sterility compromised. Lack of assurance
of sterility, as the packages may not have been sealed on the manufacturer’s
end.
VOLUME OF PRODUCT IN COMMERCE 99,345
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT CORDIS
S.M.A.R.T.® Control" Nitinol Stent System Model Number(s):
C10040SL, Manufactured in Mexico. Indicated for improving luminal diameter in
patients with symptomatic atherosclerotic disease,
CODE
10 lots. Lot #s: 13326414*, 13326415*,
133 27582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244,
13343464. (*These six lots have U.S. distribution.)
RECALLING
FIRM/MANUFACTURER Cordis Corporation, Miami Lakes, FL,
REASON
Data transcription error. The 10 affected
lots of Catalog Number C10040SL were manufactured with a prior version of the
guidewire lumen material, which is not validated with the current manufacturing
process. This condition may result in a separation of the device. If a
separation was to occur, and the separated fragment of lumen material was not
retrieved on the guidewire, blockage of the vessel could occur. If attempts to
capture the fragment are unsuccessful, surgical removal may be
required.
VOLUME OF PRODUCT IN COMMERCE 398
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Medi-Lifter III Plus Total Lift, Model 7000-2000 and b) Summit
Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity);
Mast scale is Intended to be used for weighing patients while in the lifter,
CODE
a) Serial numbers: 76001/1013,
76003/1015, 76004/1014, 76005/1017, 76027/1019, 76028/1012, 76058/1024,
76128/1034, 76129/1025, 76132/1031, 76133/1039, 76162/1033, 76164/1035,
76221/1069, 76247/1065, 76251/1070, 77091/1079, 77092/1088, 77093/1083,
77126/1084, 77127/1085, 77295/1091, 77342/1096, 77343/1093, 77406/1099,
77407/1098, 77408/1092, 78035/1134, 78036/1132, 78037/1133, 78038/1128,
78039/1103, 78040/1130, 78041/1104;
b) Serial numbers: 4800157/1020,
4800166/1077, 4800173/1086
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL,
Manufacturer:
B.H.M. Medical, Inc., Magog,
Canada.
REASON Scale
could break and fall potentially causing injuries to someone who is on it. There
is a potential for the mast scale load cell ssembly to fracture and allow the
mast/boom to fall. Should a patient be in the lift at the time, the patient
could fall and sustain injuries.
VOLUME OF PRODUCT IN
COMMERCE 37
units
DISTRIBUTION Nationwide
PRODUCT GE Healthcare Centricity Perinatal (formerly QS) System - PFILS
(Patient File Server) software; automatic patient data management providing
clinical information at the bedside in Labor & Delivery, Mother-Baby and the
Neonatal Intensive Care Unit,
CODE All CPN versions up to 6.70.6 P02 with
PFILS versions below 2.0
RECALLING FIRM/MANUFACTURER GE
Healthcare Integrated IT Solutions, Barrington, IL,
REASON Patient information mix-up: When the
PFILS application, configured with a backup server has experienced a network
interruption, PFILS verify could result in the Centricity Perinatal application
recording non-identifiable patient information to the incorrect patient
file.
VOLUME OF PRODUCT IN COMMERCE 1,031
CD-ROMs
DISTRIBUTION Nationwide and
Internationally
PRODUCT GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I,
P/N 5111-00250-010, Rx only, Irradiation Sterilized This is a microsurgical
coupler used in the anastomosis of veins and arteries normally encountered in
microsurgical vascular reconstructive procedures,
CODE
Lot numbers: 1808, 1894, 1907, 1923,
1953, 1954, 7139, 7211, 7354, 8998, 8999, 11591, 12364, 15244, 15280, 15281,
18824, 18912, 19294, 19413, 19954, 20263, 20689, 21345, 21515, 21560, 21977,
22556, and 23047
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Synovis Micro Companies Alliance Inc., Birmingham, AL,
Manufacturer: Midwest Plastics,
Saint Paul, MN.
REASON Coupler rings may slip out of the
delivery tool caused by jaws larger than specification.
VOLUME OF
PRODUCT IN COMMERCE 19,663
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Lumax
Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable,
dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software
Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three
Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the
component which is loaded/updated with software,
CODE Software version
603.U
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biotronik, Inc., Lake Oswego, OR,
Manufacturer: Biotronik Gmbh & Co, Berlin, Germany.
REASON
Timing Feature Error: An
implementation error allows the usage of the V-V timing feature, which is not
approved for use in the U.S.
VOLUME OF PRODUCT IN
COMMERCE 53
units
DISTRIBUTION Nationwide
PRODUCT Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip,
Sterile Single Use, Latex Free device packaged 25 units per case. Used to
administer fluids,
CODE Lot #
1217947
RECALLING FIRM/MANUFACTURER Smiths Medical Asd,
Inc, Dublin, OH,
REASON Misbranded/mispackaged device was
distributed. Product labeled to contain 72 inch Standard Drip ( IV)
Administration Sets, actually contained 60 inch (IV) administration sets with a'
Y' site.
VOLUME OF PRODUCT IN COMMERCE 350
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and
unassayed); list 6C50-05. Intended for use in the
verification of sensitivity, calibration linearity, and
reportable range on the Abbott ARCHITECT i System,
b)
Architect Total T4 MasterCheck; a single (specified) analyte control (assayed
and unassayed); list 6C49-05 Intended for use in the
verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System,
CODE
a) Lots: 82130M, Exp 06/30/2008; 82140M,
Exp 10/31/2008; and 82150M, Exp 12/31/2008;
b) Lots: 84110M, Exp 06/30/2008;
84120M, Exp 11/30/2008
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park,
IL,
Manufacturer: Bio-Rad Diagnostics
Group, Irvin, CA.
REASON Testing material becomes unstable at the
recommended storage temperature. Some of the Architect Free T4 MasterCheck and
Total T4 MasterCheck lots are not stable at the recommended storage condition of
2 to 8 degrees Celsius through expiration dating. These lots may exceed the
suggested tolerance limits listed in the Reportable Range/Calibration
Verification section in Appendix B of the Architect i Systems Operations
Manual.
VOLUME OF PRODUCT IN COMMERCE 325
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Flat Drain -10mm, Chariker-Jeter Dressing Kits (Large and Small)
-Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for
patients who would benefit from a suction device particularly as the device may
promote wound healing,
CODE Lot
numbers: 517141, 517269, 517143, and 517108
RECALLING
FIRM/MANUFACTURER Smith And Nephew, Inc. Wound Management Division,
Largo, FL,
REASON Incorrect labeling. Kit labels may incorrectly
state that a flat drain is contained as a kit component while some kits may
contain a round drain.
VOLUME OF PRODUCT IN
COMMERCE 4,796
kits
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 16
PRODUCT Hospira
LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is
entitled "LifeCare PCA Barcode Label Utility Program." This software program is
designed to allow entry of each drug concentration into a formulation library on
a pharmacy computer for standardized printing of barcode labels for compounded
drug product vials, CODE Version
1.0, all CDs
RECALLING FIRM/MANUFACTURER Hospira, Inc.,
Lake Forest, IL,
REASON Incorrect dosage labels created:
Customers have experienced independent changes in drug concentration (mg/mL to
mcg/mL and vice versa) and expiration dates, and the addition of trailing zeros
to the barcodes.
VOLUME OF PRODUCT IN COMMERCE 127
CDs
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for
use with high level disinfectant CIDEX OPA Concentrate
and an enzymatic detergent,
CIDEZYME GI, to achieve
cleaning and high level disinfection of heat sensitive
semi-critical endoscopes,
b) EvoTech Endoscope Cleaner
and Reprocessor, Product Code 50004-002 Indicated for use
with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent,
CIDEZYME GI, to achieve cleaning and high level
disinfection of heat sensitive semi-critical endoscopes,
CODE
a) Serial Numbers:
50004001070080, 50004001070082, 50004001070083, 50004001070043, 50004001070044, 50004001070046, 50004001070048,
50004001070023, 50004001070024, 50004001070021,
50004001070075, 50004001070045, 50004001070078, 50004001070079,
50004001070107, 50004001070110, 50004001070081,
50004001070062, 50004001070064, 50004001070063,
50004001070034, 50004001070025, 50004001070029, 50004001070047, 50004001070049, 50004001070061, 50004001070087,
50004001070088, 50004001070084,
50004001070077,
50004001070076, 50004001070085, 50004001070086, 50004001070090, 50004001070091, 50004001070094, 50004001070089,
50004001070092, 50004001070098, 50004001070097,
50004001070099, 50004001070100, 50004001070101, 50004001070105,
50004001070106, 50004001070108, 50004001070109,
50004001070102, 50004001070103, 50004001070104,
50004001070020, 50004001070031, 50004001070035, 50004001070036, 50004001070039, 50004001070042, 50004001070059,
50004001070065, 50004001070071,
50004001070072,
50004001070073, 50004001070074, 50004001070114;
b) Serial Numbers
50004002070001 and 50004002070004
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Advanced Sterilization Products,
Irvine, CA, Manufacturer:
Jabil Circuit, Inc., Auburn Hills, MI.
REASON Cleaning cycles are being cancelled.
Specific issues are: a) Water heater tank is rusting resulting in the in-line
0.2 micron filter prematurely clogging, b) Interface board malfunction resulting
in a premature lid opening, and c) Minor fluid leaks within the system (commonly
at the 0.2 micron filter attachment points).
VOLUME OF PRODUCT IN
COMMERCE 66 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
Cytomics FC 500 Flow Cytometry System with Data Innovations
Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative
and quantitative measurement of biological and physical properties of cells and
other particles,
CODE All Software
Versions
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: Beckman Coulter, Inc., Miami, FL.
REASON
Labeling
provided by two integrated software systems are not clear enough to avoid
potential demographic and sample type mismatches under certain
conditions.
VOLUME OF PRODUCT IN COMMERCE 141
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer
System Model/Catalog number 642685 Software is used to simplify acquisition of
flow cytometry data,
CODE Material
numbers 338960, 338962, and 339473
RECALLING
FIRM/MANUFACTURER BD Biosciences, San Jose, CA,
REASON
Values might not update in statistics
views after certain functions are performed in a worksheet.
VOLUME OF
PRODUCT IN COMMERCE 74 units
DISTRIBUTION Nationwide
PRODUCT 3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply
1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625
inches wide by 8 inches long) printed with a chemical indicator ink that turns
from red to green when exposed to ethylene oxide (EO) sterilization process. It
is designed to indicate whether EO has penetrated to the point of placement of
the strip, usually the center of the pack. Each strip is perforated at the
center if a shorter internal chemical indicator is preferred. An internal
chemical indicator should be used inside each pack to be sterilized,
CODE
2008-02AA, 2008-03AA, 2008-04AA,
2008-05AA, 2008-08AA, 2008-10AA, 2008-10AB, 2008-12AA, 2009-02AA, 2009-02AB,
2009-04AA, 2009-05AA, 2009-08AA, 2009-09AA,
RECALLING
FIRM/MANUFACTURER
Recalling Firm: 3M Company/Medical Division, South
St Paul, MN,
Manufacturer: Propper
Manufacturing Company, Inc., Long Island City, NY.
REASON
A production specification discrepancy
may cause the indicators to show an inaccurate result, which could incorrectly
lead customers to conclude the sterilization cycle was
adequate.
VOLUME OF PRODUCT IN COMMERCE 12,988 cases (4
boxes per case and 480 strips per box)
DISTRIBUTION Nationwide
PRODUCT
a) STERRAD 100S Sterilization System, Product Code 10101 Used to
sterilize heat and moisture sensitive reusable medical
devices,
b) STERRAD 50 Sterilization System, Product
Code 10050 Used to sterilize heat and moisture sensitive
reusable medical devices,
c) STERRAD 200 Sterilization
System, Product Code 10201 Used to sterilize heat and
moisture sensitive reusable medical devices,
d)
STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable medical devices,
e) STERRAD 100NX Sterilizer, Product Code 10104 Used to
sterilize heat and moisture sensitive reusable medical
devices, CODE All serial
numbers
RECALLING FIRM/MANUFACTURER Advanced
Sterilization Products, Irvine, CA,
REASON Oil mist filter fails
allowing oil mist to be emitted into the vicinity of the sterilizer, which may
result in the release of a mist, "haze," or "smoke."
VOLUME OF
PRODUCT IN COMMERCE 9,950 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) VECTRA GENISYS, electromechanical therapeutic ultrasound device,
Model No. 2759, Chattanooga Group, b) INTELECT LEGEND XT, electromechanical therapeutic ultrasound
and powered muscle stimulation device, Model No. 2760,
Chattanooga Group,
c) VECTRA GENISYS, electromechanical
therapeutic ultrasound and powered muscle stimulation
device, Model No. 2761, Chattanooga Group,
d) INTELECT
TRANSPORT ULTRASOUND, electromechanical therapeutic
ultrasound device, Model No. 2782, Chattanooga Group,
CODE
a) Serial numbers: 1000, 1002, 1003,
1004, 1005, 1007, 1008, 1010, 1011, 1012, 1013, 1014,
1015, 1016, 1017, 1018, 1019, 1021, 1025, 1026, 1028, 1029, 1030, 1031, 1032, 1034, 1035, 1036, 1037, 1039, 1040, 1042, 1043, 1044,
1045, 1046, 1047, 1050, 1051, 1054, 1056, 1058, 1059,
1060, 1061, 1062, 1064, 1066, 1067, 1069, 1071, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1081, 1082, 1083, 1085,
1086, 1087, 1088, 1089, 1091, 1095, 1096, 1097, 1100,
1102, 1103, 1112, 1114, 1120, 1121, 1122, 1123, 1124, 1125, 1130, 1135, 1137, 1138, 1141, 1142, 1143, 1145, 1146,
1147, 1148, 1149, 1150, 1153, 1157, 1158, 1162, 1163,
1168, 1169, 1171, 1176, 1177, 1178, 1180, 1181, 1186, 1191, 1193, 1194, 1195, 1196, 1197, 1198, 1200, 1201, 1203,
1206, 1207, 1208, 1209, 1210,
1211, 1213, 1215, 1216,
1217, 1220, 1221, 1222, 1225, 1226, 1227, 1228, 1229, 1231, 1232, 1233, 1235, 1236, 1237, 1238, 1239, 1240, 1241,
1247, 1248, 1249, 1254, 1255, 1256, 1259, 1261, 1262,
1266, 1269, 1273, 1275, 1277, 1278, 1279, 1280, 1281, 1282, 1283, 1285, 1286, 1289, 1291, 1293, 1294, 1295, 1296,
1300, 1301, 1302, 1303, 1304, 1305, 1307, 1308, 1309,
1310, 1313, 1314, 1319, 1320, 1329, 1330, 1333, 1339, 1341, 1344, 1346, 1348, 1349, 1351, 1359, 1360, 1361, 1362,
1363, 1364, 1369, 1370, and 1373;
b) Serial numbers: 1017, 1022, 1028, 1031,
1035, 1040, 1041, 1043, 1046, 1048, 1049, 1050, 1053,
1055, 1056, 1058, 1059, 1061, 1062, 1065, 1066, 1067, 1071, 1072, 1074, 1076, 1080, 1081, 1085, 1086, 1087, 1088, 1089, 1091,
1092, 1093, 1094, 1095, 1098, 1100, 1101, 1104, 1105,
1107, 1108, 1111, 1114, 1135, 1136, 1138, 1139, 1157, 1158,
1160, 1162, 1163, 1164, 1167, 1168, 1169, 1171,
1172, 1174, 1177, 1201, 1202, 1203, 1206, 1207, 1212,
1213, 1214, 1220, 1224, 1225, 1238, 1243, 1245, 1252, 1253, 1254, 1255, 1256, 1257, 1258, 1259, 1260, 1262, 1264, 1265,
1266, 1269, 1271, 1272, 1273, 1274, 1275, 1278, 1279,
1285, 1288, 1289, 1290, 1311, 1313, 1314, 1316, 1317, 1321, 1322, 1324, 1326, 1327, 1328, 1329, 1330, 1331, 1333,
1334, 1338, 1340, 1341, 1342,
1344, 1349, 1350, 1351,
1353, 1354, 1359, 1361, 1362, 1364, 1367, 1368, 1389, 1390, 1392, 1393, 1394, 1395, 1397, 1400, 1401, 1403, 1404,
1405, 1406, 1411, 1413, 1422, 1424, 1432, 1439, 1440,
1447, 1448, 1450, 1454, 1460, 1461, 1463, 1465, 1467, 1469, 1542, 1550, 1556, 1558, 1560, 1566, 1568, 1570, 1571,
1573, 1574, 1576, 1589, 1602, 1604, 1605, 1606, 1607,
1610, 1611, 1613, 1614, 1616, 1618, 1619, 1621, 1622, 1623, 1625, 1626, 1628, 1629, 1632, 1633, 1635, 1641, 1643,
1644, 1646, 1647, 1651, 1654, 1655, 1657, 1659, 1660,
1662, 1663, 1665, 1691, 1697, 1699, 1701, 1703, 1704, 1705, 1706, 1712, 1713, 1719, 1720, 1727, 1729, 1730, 1754,
1759, 1760, 1763, 1766, 1773, 1775, 1776, 1777, 1780,
1781, 1782, 1784, 1785, 1786, 1792, 1793, 1798, 1799, 1802,
1809, 1813, 1819, 1820, 1821, 1825, 1830, 1832, 1834,
1835, 1842, 1846, 1850, 1852, 1855, 1859, 1861, 1865,
1907, 1909, 1910, 1911, 1914, 1918, 1921, 1925, 1926, 1927, 1928, 1929, 1933, 1934, 1938, 1940, 1974, 1978, 1979,
1983, 1984, 1985, 1988, 1990, 1995, 1996, 1998, 2000,
2008, 2010, 2011, 2012, 2021, 2022, 2024, 2032, 2035, 2036, 2037, 2038, 2040, 2041, 2045, 2046, 2049, 2050, 2052,
2056, 2057, 2058, 2059, 2063, 2064, 2067, 2074, 2075,
2076, 2078, 2079, 2082, 2083, 2089, 2090, 2092, 2093, 2094, 2097, 2099, 2100, 2104, 2172, 2173, 2174, 2181, 2185,
2189, 2190, 2191, 2194, 2196, 2199, 2202, 2204, 2205,
2209, 2212, 2213, 2214, 2216, 2218, 2219, 2221, 2223, 2224, 2225, 2230, 2235, 2238, 2243, 2247, 2248, and 2282;
c)
Serial numbers: 1037, 1038, 1041, 1042, 1045, 1049, 1050, 1055, 1056, 1061,
1062, 1063, 1064, 1066, 1067, 1068, 1071, 1073, 1074,
1075, 1076, 1117, 1119, 1122, 1123, 1124, 1128, 1129,
1130, 1131, 1132, 1133, 1135, 1137, 1138, 1139, 1140, 1141, 1143, 1144, 1145, 1146, 1148, 1149, 1150, 1153, 1155, 1156,
1207, 1208, 1209, 1212, 1215, 1222, 1223, 1224, 1226,
1228, 1229, 1230, 1231, 1232, 1233, 1234, 1235, 1236, 1238, 1240, 1242, 1244, 1245, 1247, 1248, 1250, 1251, 1253,
1254, 1256, 1257, 1258, 1260, 1262, 1265, 1266, 1362,
1364, 1365, 1366, 1370, 1372, 1374, 1375, 1377, 1378, 1381, 1382, 1383, 1384, 1413, 1414, 1415, 1416, 1417, 1421,
1422, 1424, 1425, 1427, 1428, 1429, 1430, 1433, 1434,
1435, 1436, 1464, 1467, 1468, 1470, 1472, 1473, 1474, 1480,
1481, 1485, 1486, 1487, 1489, 1491, 1492, 1493, 1494,
1495, 1497, 1499, 1500, 1502, 1503, 1504, 1505, 1507,
1508, 1509, 1510, 1563, 1565, 1570, 1573, 1574, 1578, 1579, 1586, 1612, 1613, 1615, 1616, 1616, 1617, 1618, 1619,
1620, 1625, 1626, 1627, 1630, 1632, 1634, 1635, 1636,
1638, 1639, 1642, 1643, 1644, 1645, 1667, 1668, 1669, 1670, 1672, 1673, 1675, 1677, 1679, 1680, 1683, 1685, 1737,
1738, 1741, 1742, 1743, 1744, 1745, 1746, 1747, 1748,
1749, 1753, 1754, 1755, 1756, 1757, 1759, 1761, 1762, 1763, 1764, 1765, 1767, 1775, 1776, 1777, 1779, 1780, 1784,
1785, 1787, 1788, 1789, 1790, 1791, 1818, 1819, 1820,
1821, 1822, 1826, 1828, 1830, 1832, 1834, 1835, 1836, 1838, 1840, 1846, 1847, 1848, 1852, 1853, 1855, 1857, 1858,
1861, 1862, 1864, 1865, 1867,
1868, 1869, 1870, 1872,
1874, 1876, 1878, 1881, 1882, 1887, 1889, 1891, 1892, 1894, 1898, 1900, 1902, 1954, 1956, 1957, 1961, 1964, 1965,
1967, 1972, 1975, 1976, 1977, 1979, 1980, 1983, 1985,
1989, 1990, 1992, 1995, 1996, 1997, 1998, 2000, 2001, 2005, 2007, 2008, 2011, 2012, 2013, 2014, 2017, 2018, 2019,
2020, 2025, 2028, 2036, 2037, 2039, 2041, 2118, 2128,
2129, 2131, 2133, 2136, 2139, 2141, 2144, 2145, 2146, 2148,
2150, 2152, 2156, 2158, 2160, 2162, 2163, 2164, 2166, 2168, 2170, 2172,
2175, 2177, 2181, 2186, 2187, 2197, 2198, 2199, 2201,
2203, 2205, 2207, 2211, 2214, 2217, 2222, 2223, 2224,
2227, 2230, 2237, 2239, 2240, 2241, 2246, 2248, 2253, 2254, 2256, 2259, 2260, 2290, 2293, 2295, 2296, 2298, 2303, 2376, 2378,
2381, 2383, 2384, 2391, 2392,
2393, 2394, 2396, 2397,
2398, 2399, 2401, 2402, 2404, 2407, 2411, 2412, 2414, 2417, 2419, 2425, 2432, 2435, 2436, 2439, 2445, 2446, 2448,
2453, 2457, 2458, 2461, 2464, 2469, 2475, 2478, 2481,
2482, 2490, 2494, 2498, 2505, 2575, 2727, 2731, 2735, 2740, 2747, 2750, 2756, 2763, 2776, 2778, 2779, 2784, 2792,
2793, 2796, 2814, 2815, 2816, 2819, 2867, 2889, 2892,
2898, 2982, 2988, 2989, 2990, 2994, 2995, 2999, 3000, 3003, 3005, 3006, 3008, 3009, 3011, 3013, 3014, 3015, 3018,
3021, 3083, 3092, and 3102;
d) Serial numbers: 1000, 1001, 1004, 1005, 1008,
1009, 1010, 1011, 1014, 1016, 1017, 1019, 1021, 1022,
1023, 1028, 1029, 1032, 1033, 1034, 1037, 1039, 1041, 1042, 1043, 1044, 1045, 1046, 1049, 1050, 1053, 1054, 1057, 1059,
1061, 1062, 1064, 1065, 1066, 1067, 1068, 1069, 1070,
1073, 1076, 1077, 1078, 1079, 1080, 1081, 1085, 1086, 1087, 1088, 1089, 1090, 1092, 1093, 1094, 1096, 1097, 1099,
1100, 1101, 1103, 1105, 1107, 1113, 1114, 1115, 1116,
1117, 1120, 1122, 1124, 1126, 1130, 1131, 1132, 1133, 1134, 1135, 1137, 1138, 1141, 1143, 1145, 1146, 1147, 1149,
1150, 1152, 1153, 1155, 1157, 1158, 1161, 1163, 1164,
1165, 1166, 1167, 1168, 1171, 1172, 1173, 1174, 1175, 1176, 1177, 1182, 1184, 1186, 1189, 1190, 1191, 1192, 1194,
1195, 1196, 1198, 1199, 1203,
1204, 1207, 1208, 1209,
1212, 1213, 1214, 1216, 1218, 1220, 1221, 1222, 1223, 1224, 1225, 1226, 1229, 1230, 1232, 1233, 1235, 1236, 1237,
1240, 1242, 1243, 1244, 1245, 1246, 1247, 1248, 1249,
1250, 1251, 1252, 1253, 1254, 1255, 1256, 1257, 1258, 1260, 1261, 1263, 1264, 1265, 1267, 1268, 1270, 1271, 1273,
1276, 1278, 1279, 1282, 1284, 1287, 1288, 1294, 1300,
1301, 1303, 1306, 1307, 1308, 1309, 1310, 1311, 1313, 1314, 1315, 1316, 1318, 1321, 1323, 1325, 1326, 1327, 1328,
1329, 1330, 1331, 1332, 1334, 1336, 1337, 1338, 1339,
1340, 1341, 1343, 1344, 1346, 1347, 1350, 1351, 1353, 1354, 1357, 1358, 1362, 1365, 1367, 1368, 1369, 1371, 1372,
1376, 1377, 1382, 1384, 1386, 1387, 1389, 1390, 1391,
1392, 1394, 1396, 1398, 1399, 1400, 1401, 1403, 1404, 1405,
1406, 1407, 1408, 1409, 1411, 1412, 1413, 1414, 1415,
1417, 1418, 1419, 1421, 1422, 1425, 1426, 1427, 1428,
1431, 1432, 1433, 1434, 1436, 1437, 1439, 1440, 1441, 1443, 1444, 1445, 1446, 1448, 1449, 1450, 1453, 1455, 1458,
1459, 1460, 1462, 1463, 1464, 1473, 1474, 1475, 1476,
1477, 1478, 1479, 1480, 1483, 1484, 1485, 1488, 1489, 1490, 1491, 1492, 1493, 1495, 1496, 1497, 1498, 1499, 1500,
1504, 1506, 1513, 1518, 1522, 1524, 1525, 1526, 1529,
1533, 1534, 1535, 1536, 1537, 1540, 1541, 1542, 1544, 1546, 1548, 1551, 1552, 1554, 1555, 1557, 1558, 1559, 1560,
1562, 1563, 1564, 1565, 1570, 1572, 1573, 1575, 1577,
1578, 1579, 1581, 1582, 1587, 1588, 1591, 1593, 1594, 1595, 1597, 1600, 1602, 1606, 1607, 1608, 1610, 1611, 1612,
1613, 1614, 1615, 1616, 1617,
1618, 1623, 1624, 1626,
1628, 1629, 1630, 1634, 1635, 1637, 1638, 1639, 1641, 1643, 1645, 1647, 1648, 1649, 1650, 1651, 1652, 1653, 1655,
1656, 1657, 1658, 1659, 1660, 1661, 1664, 1665, 1667,
1668, 1671, 1672, 1675, 1676, 1677, 1678, 1679, 1683, 1684, 1687, 1688, 1689, 1690, 1695, 1697, 1699, 1700, 1701,
1702, 1705, 1706, 1707, 1710, 1711, 1713, 1714, 1717,
1720, 1721, 1722, 1724, 1725, 1726, 1729, 1730, 1731, 1732, 1733, 1737, 1738, 1743, 1744, 1746, 1747, 1749, 1750,
1752, 1753, 1754, 1756, 1758, 1761, 1767, 1768, 1770,
1772, 1776, 1778, 1779, 1780, 1782, 1785, 1786, 1788, 1789, 1790, 1792, 1798, 1799, 1802, 1804, 1810, 1813, 1815,
1819, 1821, 1822, 1823, 1826, 1827, 1829, 1833, 1836,
1837, 1841, 1843, 1844, 1845, 1847, 1848, 1850, 1852, 1876,
1878, 1879, 1880, 1884, 1887, 1888, 1889, 1892, and
1893
RECALLING FIRM/MANUFACTURER Chattanooga Corporation,
Inc., Hixson, TN,
REASON Device may fail to
administer therapy during use.
VOLUME OF PRODUCT IN
COMMERCE 1,565 units
DISTRIBUTION Nationwide
PRODUCT
a) BD
DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y
UNLABELED LYOPH,
The product is packaged in 1 vial units.
For use in slide agglutination tests for serotyping
Neisseria Meningitidis,
b) BD DifcoTM
Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were
labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH. The product is
packaged in 1 vial units. For use in slide agglutination tests for serotyping
Neisseria Meningitidis,
c) BD DifcoTM Neisseria
Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y
UNLABELED LYOPH. The product is packaged in 100 vial
units For use in slide agglutination tests for serotyping
Neisseria Meningitidis,
d) BD DifcoTM Neisseria
Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y
UNLABELED LYOPH. The product is packaged in 100 vial
units For use in slide agglutination tests for serotyping
Neisseria Meningitidis,
CODE
a) Lot
#6311396, EXP 2009-09-19;
b) Lot #6250885, EXP 2009-02-26;
c) Lot
#6104713, EXP 2009-02-26;
d) Lot #7136172, EXP
2009-09-19
RECALLING FIRM/MANUFACTURER
Recalling Firm:
BD
Diagnostic Systems / Lee Laboratories, Grayson, GA,
Manufacturer:
Becton Dickinson, Sparks, MD.
REASON Exhibits cross reactivity with
Neisseria meningitides Group W135
VOLUME OF PRODUCT IN
COMMERCE 1,440 units
DISTRIBUTION Nationwide
and Internationally
WEEK ENDING AUGUST 23
PRODUCT
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. US - Material Number
(UPN) M001553030, Catalog Number 55-303;
OUS - Material Number (UPN) M001553000, Catalog Number 55-300;
CODE
US Lot/Batch #: C71403, C71404, C71405, C71406, C71501, C71502, C71601, C71602, C72302, C72303, C72401, C72402, C72403, C72404, C72701, C72801, C72802, C72803, C72901, C72902, C72903, C72904, C73002, C73003, C73103, C73104, C73105, C73201, C73202, C73203, C73204, C73205, C73301, C73302, C73401, C73402, C73601, C73602, C73801, C74301, C74302, C74401, C74502, C74601, C74701, C80201, C80202, C80203, C80301, C80401, C80402, C80403, C80501, C80801, C80802, C81001, C81002, C81102, C81201, C81202, and C81203;
OUS Lot/Batch #: C72501, C72502, C72601, C72602, C72905, C73001, C73004, C73101, C73102, C73901, C73902, C73903, C74001, C74002, C74003, and C74101
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Maple Grove, MN,
Manufacturer: Boston Scientific Cupertino, Corporation, Cupertino, CA.
REASON
Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Since the potential for the tip to detach occurs during delivery of the
stent, this recall does not affect stents that have already been implanted. Patients who have already received a NexStent Carotid Stent are at no additional risk with respect to this product issue.
VOLUME OF PRODUCT IN COMMERCE
1,946 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical
chemistry analyzer; Catalog number 04998618001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests;
b) Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical
chemistry analyzer; Catalog number 04998669001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests;
c) Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay
analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative
and quantitative in vitro determinations using a wide variety of tests;
d) Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical
chemistry analyzer; Catalog number 03284522001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests;
e) Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay
analyzer; Catalog number 03284549001. Intended for qualitative and quantitative in
vitro determinations using a wide variety of tests;
CODE
All units with software version 08-02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN,
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan.
REASON
Possible mismatch between patient and result.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide
PRODUCT
Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks,
CODE
All serial numbers between H080002 to H080006, H080008 to H080014, H080016 to H080022, H080024 to H080050, H080052 to H080057, H080059 to H080066, H080068 to H080070, H080072 to H080075, H080077, H080078, H080080 to H080089, H080091, H080092, H080094 to H080105, H080107 to H080117, H080119 to H080134, H080136, H080137, H080139 to H080145, H080147 to H080158, H080160 to H080163, H080166, H080168 to H080200, H080202 to H080222, H080224 to H080228, H080230 to H080232, H080235, H080236, H080239, H080240, H080244, H080246 to H080248, H080251, H080254, H080256 to H080258, H080260 to H080263, H080265 to H080268, H080271 to H080282, H080286 to H080288, H080290 to H080292, H080294, H080296, H080301, H080303, H080304, H080306, H080307, H080309, H080311, H080312, H080314, H080318, H080320, H080321, H080324, H080325, H080328, H080329, H080335, H080348, H080351, H082000 to H082002, H082007, H082009 to H082012, H082020 to H082023, H082026, H082034, H082036, H082038, H082043, H082044, H082048, H082070, H082073, H082088, H082204
RECALLING FIRM/MANUFACTURER Varian Medical Systems Oncology Systems, Palo Alto, CA,
REASON
If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
VOLUME OF PRODUCT IN COMMERCE
291 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) Philips Medical Systems iSite PACS (Picture Archiving and Communications
Systems) version 3.6.28.0 - Radiology Image management system;
b) Philips Medical Systems iSite PACS (Picture Archiving and Communications
Systems) version 4.1.17.0 - Radiology Image management system;
CODE
a) Version number 3.6.28.0;
b) Version 4.1.17.0
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA,
REASON
When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a discrepancy exists in the measurement provided by the tool.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for
fixation of bone fractures or for bone reconstruction. Catalog number: 111426S;
b) QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for
fixation of bone fractures or for bone reconstruction. Catalog Number 222428S;
CODE
a) Lot E54Q;
b) Lot E54R
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ,
Manufacturer: NewDeal SA, Lyon, France.
REASON
Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labeled with an incorrect length.
VOLUME OF PRODUCT IN COMMERCE
a) 42; b) 20
DISTRIBUTION
Nationwide
PRODUCT
a) Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator The ventilator is
suitable for use in institutional, home or transport settings. Fully self-contained
ventilator in a compact and lightweight design. It can operate from an internal
battery, external battery or AC power. Applications include long term acute care or
short term / recovery room;
b) Viasys healthcare, Pulmonetic Systems LTV 950 Ventilator The ventilator is
suitable for use in institutional, home or transport settings. Fully self-contained
ventilator in a compact and lightweight design. It can operate from an internal battery,
external battery or AC power. Applications include long term acute care or short term /
recovery room.
c) Viasys healthcare, Pulmonetic Systems LTV 900 Ventilator The ventilator is
suitable for use in institutional, home or transport settings. Fully self-contained
ventilator in a compact and lightweight design. It can operate from an internal battery,
external battery or AC power. Applications include long term acute care or short term /
recovery room;
d) Viasys healthcare, Pulmonetic Systems LTV 800 Ventilator The ventilator is
suitable for use in institutional, home or transport settings. Fully self-contained
ventilator in a compact and lightweight design. It can operate from an internal battery,
external battery or AC power. Applications include long term acute care or short term /
recovery room;
e) Replacement Kit, Power PCBA with DC power cord. REF 11590;
f) Replacement Kit, Power PCBA without Memory Board. REF 14157;
g) Replacement Kit, Power PCBA with Memory PCBA. REF 14425;
h) Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US;
CODE
a) Serial numbers: A01014, A01016, A01020, A01021, A01023, A01024, A01025, A01026, A01027, A01028, A01029, A01030, A01033, A01038, A01039, A01040, A01043, A01045, A01048, A01049, A01050, A01051, A01052, A01053, A01054, A01055, A01056, A01059, A01062, A01063, A01064, A01067, A01068, A01069, A01070, A01073, A01075, A01076, A01077, A01079, A01082, A01083, A01086, A01087, A01088, A01089, A01090, A01096, A01106, A01109, A01112, A01117, A01118, A01119, A01121, A01123, A01125, A01126, A01127, A01128, A01131, A01132, A01134, A01135, A01140, A01142, A01150, A01162, A01171, A01172, A01175, A01177, A01178, A01179, A01181, A01183, A01184, A01188, A01190, A01192, A01193, A01197, A01199, A01201, A01204, A01205, A01206, A01210, A01212, A01213, A01219, A01220, A01221, A01223, A01224, A01228, A01230, A01238, A01239, A01240, A01241, A01243, A01244, A01245, A01246, A01247, A01248, A01251, A01253, A01255, A01256, A01257, A01263, A01264, A01266, A01268, A01270, A01272, A01274, A01282, A01285, A01286, A01292, A01296, A01297, A01298, A01299, A01301, A01302, A01303, A01304, A01305, A01307, A01310, A01312, A01314, A01315, A01316, A01318, A01319, A01321, A01323, A01324, A01327, A01328, A01331, A01335, A01337, A01338, A01344, A01346, A01347, A01349, A01350, A01352, A01353, A01354, A01355, A01356, A01357, A01358, A01359, A01360, A01361, A01363, A01364, A01366, A01367, A01368, A01370, A01375, A01376, A01379, A01383, A01387, A01389, A01391, A01392, A01393, A01394, A01395, A01397, A01399, A01401, A01403, A01405, A01406, A01409, A01410, A01415, A01416, A01418, A01420, A01422, A01423, A01427, A01428, A01429, A01430, A01431, A01432, A01433, A01434, A01435, A01437, A01438, A01440, A01441, A01443, A01444, A01445, A01446, A01447, A01448, A01449, A01450, A01453, A01454, A01455, A01456, A01459, A01460, A01461, A01462, A01463, A01464, A01465, A01466, A01468, A01473, A01476, A01479, A01480, A01482, A01484, A01486, A01487, A01488, A01489, A01490, A01493, A01494, A01495, A01496, A01497, A01499, A01500, A01503, A01505, A01508, A01509, A01512, A01515, A01516, A01518, A01519, A01521, A01523, A01526, A01532, A01534, A01538, A01539, A01540, A01541, A01542, A01544, A01545, A01551, A01553, A01556, A01559, A01561, A01572, A01574, A01576, A01577, A01578, A01583, A01587, A01588, A01593, A01594, A01596, A01597, A01599, A01600, A01601, A01603, A01604, A01607, A01608, A01618, A01620, A01631, A01633, A01634, A01635, A01636, A01637, A01638, A01639, A01640, A01641, A01642, A01645, A01646, A01649, A01651, A01652, A01654, A01659, A01662, A01665, A01666, A01668, A01675, A01676, A01681, A01683, A01684, A01685, A01686, A01687, A01688, A01690, A01691, A01694, A01697, A01698, A01699, A01700, A01701, A01709, A01712, A01714, A01715, A01717, A01719, A01721, A01723, A01724, A01725, A01729, A01734, A01735, A01736, A01741, A01745, A01747, A01748, A01749, A01751, A01752, A01753, A01754, A01756, A01758, A01760, A01762, A01763, A01766, A01767, A01768, A01769, A01770, A01771, A01772, A01773, A01774, A01776, A01778, A01783, A01791, A01792, A01793, A01795, A01800, A01802, A01803, A01804, A01807, A01810, A01811, A01813, A01814, A01815, A01816, A01817, A01823, A01827, A01835, A01836, A01838, A01844, A01846, A01847, A01850, A01851, A01852, A01857, A01860, A01862, A01863, A01865, A01873, A01876, A01878, A01880, A01881, A01886, A01887, A01888, A01890, A01891, A01892, A01893, A01894, A01897, A01898, A01899, A01901, A01902, A01903, A01904, A01905, A01907, A01908, A01909, A01911, A01913, A01914, A01917, A01920, A01925, A01926, A01927, A01929, A01931, A01932, A01935, A01940, A01944, A01947, A01950, A01951, A01954, A01957, A01959, A01960, A01963, A01964, A01965, A01966, A01971, A01973, A01974, A01978, A01979, A01981, A01982, A01986, A01987, A01988, A01991, A01993, A01996, A01997, A02009, A02014, A02015, A02017, A02019, A02020, A02022, A02023, A02024, A02025, A02027, A02028, A02029, A02030, A02031, A02032, A02035, A02036, A02037, A02038, A02040, A02048, A02050, A02052, A02054, A02055, A02056, A02063, A02065, A02069, A02071, A02072, A02073, A02075, A02078, A02080, A02086, A02092, A02095, A02096, A02097, A02103, A02105, A02107, A02108, A02114, A02117, A02120, A02121, A02123, A02124, A02126, A02128, A02129, A02133, A02135, A02138, A02139, A02140, A02143, A02144, A02145, A02147, A02148, A02149, A02150, A02152, A02154, A02155, A02156, A02157, A02158, A02159, A02163, A02167, A02170, A02177, A02182, A02188, A02189, A02190, A02191, A02192, A02193, A02194, A02197, A02198, A02199, A02200, A02206, A02210, A02213, A02215, A02216, A02217, A02218, A02219, A02220, A02221, A02225, A02227, A02228, A02230, A02231, A02232, A02233, A02234, A02235, A02239, A02242, A02249, A02250, A02253, A02257, A02259, A02262, A02267, A02268, A02274, A02276, A02279, A02281, A02289, A02290, A02291, A02295, A02303, A02304, A02321, A02322, A02343, A02344, A02345, A02347, A02349, A02351, A02352, A02353, A02355, A02356, A02357, A02358, A02360, A02361, A02363, A02366, A02369, A02370, A02403, A02404, A02405, A02406, A02407, A02408, A02409, A02410, A02411, A02412, A02413, A02414, A02416, A02417, A02418, A02419, A02420, A02422, A02424, A02425, A02426, A02430, A02432, A02433, A02434, A02437, A02440, A02451, A02457, A02459, A02463, A02465, A02466, A02468, A02473, A02474, A02476, A02477, A02484, A02488, A02489, A02490, A02496, A02499, A02503, A02506, A02508, A02509, A02510, A02512, A02513, A02515, A02516, A02518, A02519, A02523, A02524, A02525, A02526, A02527, A02528, A02529, A02531, A02538, A02539, A02541, A02542, A02544, A02546, A02547, A02548, A02550, A02557, A02558, A02559, A02562, A02565, A02566, A02568, A02578, A02580, A02581, A02582, A02583, A02584, A02587, A02590, A02592, A02595, A02606, A02609, A02611, A02612, A02613, A02621, A02628, A02630, A02633, A02634, A02635, A02636, A02637, A02638, A02641, A02642, A02644, A02645, A02647, A02650, A02653, A02654, A02657, A02658, A02660, A02665, A02666, A02667, A02670, A02672, A02686, A02688, A02689, A02692, A02714, A02715, A02718, A02722, A02723, A02727, A02729, A02732, A02736, A02739, A02747, A02748, A02749, A02752, A02753, A02756, A02757, A02758, A02761, A02762, A02764, A02765, A02766, A02768, A02769, A02770, A02772, A02774, A02775, A02778, A02779, A02780, A02781, A02782, A02783, A02784, A02786, A02787, A02788, A02789, A02790, A02793, A02798, A02799, A02802, A02803, A02805, A02806, A02808, A02814, A02816, A02821, A02822, A02823, A02825, A02826, A02827, A02831, A02834, A02835, A02838, A02841, A02842, A02847, A02850, A02852, A02853, A02855, A02857, A02859, A02861, A02864, A02865, A02867, A02868, A02869, A02871, A02875, A02879, A02881, A02883, A02884, A02885, A02886, A02888, A02891, A02895, A02903, A02904, A02907, A02909, A02910, A02911, A02913, A02914, A02915, A02916, A02918, A02919, A02920, A02921, A02922, A02923, A02924, A02925, A02926, A02927, A02930, A02932, A02935, A02937, A02943, A02944, A02951, A02954, A02961, A02965, A02966, A02972, A02973, A02976, A02977, A02978, A02979, A02980, A02981, A02982, A02983, A02984, A02987, A02988, A02990, A02991, A02992, A02993, A02998, A03000, A03003, A03004, A03005, A03007, A03008, A03009, A03011, A03012, A03014, A03015, A03017, A03018, A03021, A03026, A03027, A03031, A03034, A03040, A03042, A03044, A03045, A03046, A03047, A03052, A03054, A03058, A03059, A03060, A03063, A03064, A03065, A03066, A03067, A03072, A03076, A03082, A03083, A03085, A03087, A03090, A03091, A03092, A03097, A03098, A03101, A03103, A03107, A03108, A03110, A03116, A03122, A03123, A03127, A03128, A03137, A03139, A03140, A03142, A03147, A03150, A03156, A03158, A03161, A03162, A03163, A03167, A03168, A03169, A03170, A03172, A03174, A03175, A03176, A03177, A03178, A03179, A03180, A03183, A03184, A03186, A03192, A03199, A03214, A03215, A03216, A03217, A03218, A03219, A03220, A03221, A03227, A03228, A03229, A03230, A03231, A03232, A03233, A03234, A03235, A03236, A03237, A03238, A03239, A03245, A03246, A03247, A03248, A03253, A03254, A03255, A03256, A03257, A03258, A03259, A03260, A03261, A03262, A03263, A03264, A03265, A03266, A03267, A03268, A03269, A03271, A03272, A03275, A03278, A03281, A03285, A03286, A03289, A03290, A03291, A03292, A03294, A03296, A03298, A03299, A03300, A03301, A03303, A03304, A03305, A03308, A03310, A03311, A03312, A03313, A03315, A03323, A03327, A03328, A03330, A03332, A03339, A03343, A03355, A03357, A03358, A03360, A03362, A03365, A03366, A03367, A03372, A03375, A03377, A03381, A03386, A03388, A03389, A03391, A03392, A03393, A03394, A03395, A03398, A03399, A03400, A03402, A03403, A03404, A03405, A03406, A03407, A03408, A03409, A03429, A03434, A03442, A03444, A03447, A03450, A03454, A03456, A03457, A03459, A03460, A03465, A03466, A03467, A03468, A03470, A03472, A03485, A03490, A03496, A03498, A03508, A03511, A03514, A03519, A03520, A03522, A03525, A03526, A03531, A03533, A03534, A03535, A03539, A03540, A03541, A03542, A03543, A03544, A03545, A03546, A03547, A03549, A03550, A03551, A03553, A03555, A03556, A03557, A03558, A03559, A03560, A03561, A03562, A03563, A03564, A03565, A03566, A03567, A03568, A03569, A03570, A03572, A03573, A03574, A03575, A03576, A03577, A03578, A03579, A03580, A03581, A03582, A03584, A03585, A03586, A03587, A03590, A03593, A03595, A03599, A03600, A03601, A03606, A03607, A03608, A03610, A03611, A03614, A03617, A03619, A03622, A03623, A03626, A03633, A03637, A03638, A03640, A03649, A03650, A03652, A03653, A03655, A03659, A03660, A03661, A03665, A03666, A03667, A03671, A03673, A03674, A03676, A03677, A03678, A03680, A03681, A03682, A03684, A03685, A03686, A03687, A03688, A03691, A03692, A03693, A03697, A03698, A03701, A03704, A03705, A03707, A03709, A03710, A03711, A03712, A03715, A03718, A03719, A03720, A03721, A03722, A03724, A03725, A03726, A03729, A03731, A03732, A03733, A03735, A03736, A03737, A03739, A03742, A03743, A03745, A03747, A03749, A03750, A03753, A03755, A03756, A03764, A03765, A03766, A03767, A03768, A03770, A03772, A03775, A03777, A03778, A03780, A03781, A03783, A03784, A03785, A03788, A03792, A03796, A03797, A03798, A03799, 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A09244, A09246, A09247, A09248, A09249, A09250, A09251, A09253, A09254, A09255, A09256, A09257, A09259, A09260, A09261, A09262, A09263, A09264, A09265, A09265, A09266, A09267, A09268, A09269, A09270, A09271, A09272, A09273, A09274, A09275, A09276, A09278, A09279, A09280, A09281, A09282, A09283, A09284, A09285, A09286, A09287, A09288, A09290, A09291, A09292, A09293, A09294, A09295, A09296, A09297, A09299, A09300, A09302, A09303, A09304, A09305, A09306, A09307, A09308, A09309, A09310, A09311, A09312, A09313, A09314, A09315, A09316, A09317, A09318, A09319, A09320, A09321, A09322, A09323, A09324, A09325, A09326, A09327, A09328, A09329, A09330, A09331, A09332, A09333, A09334, A09335, A09336, A09338, A09340, A09341, A09342, A09344, A09345, A09346, A09347, A09348, A09349, A09350, A09351, A09352, A09353, A09354, A09355, A09356, A09357, A09358, A09359, A09360, A09361, A09362, A09363, A09364, A09365, A09366, A09367, A09368, A09369, A09370, A09371, A09372, A09373, A09374, A09375, A09376, A09377, A09379, A09380, A09381, A09382, A09383, A09384, A09385, A09386, A09387, A09388, A09389, A09390, A09391, A09392, A09393, A09394, A09395, A09396, A09397, A09398, A09399, A09400, A09401, A09402, A09403, A09404, A09405, A09406, A09407, A09408, A09409, A09410, A09411, A09412, A09413, A09414, A09415, A09416, A09418, A09419, A09420, A09421, A09422, A09423, A09424, A09425, A09426, A09427, A09428, A09429, A09430, A09431, A09432, A09433, A09434, A09435, A09436, A09437, A09438, A09439, A09440, A09441, A09442, A09443, A09444, A09445, A09446, A09447, A09448, A09449, A09450, A09451, A09452, A09453, A09454, A09455, A09457, A09458, A09459, A09460, A09461, A09462, A09463, A09464, A09465, A09466, A09467, A09468, A09469, A09470, A09471, A09472, A09473, A09474, A09475, A09476, A09477, A09478, A09479, A09480, A09481, A09482, A09483, A09484, A09485, A09486, A09487, A09488, A09489, A09490, A09491, A09492, A09493, A09494, A09495, A09496, A09497, A09499, A09500, A09501, A09502, A09503, A09504, A09505, A09506, A09507, A09508, A09510, A09511, A09513, A09514, A09515, A09516, A09517, A09518, A09519, A09520, A09521, A09522, A09523, A09524, A09525, A09526, A09527, A09528, A09529, A09530, A09531, A09532, A09533, A09534, A09535, A09536, A09537, A09538, A09539, A09540, A09541, A09542, A09543, A09544, A09545, A09546, A09547, A09548, A09550, A09551, A09552, A09553, A09554, A09555, A09557, A09558, A09559, A09560, A09561, A09562, A09567, A09580, A09588, A09640, A09645, A09647, A09648, A09862, A09866, A10461;
b) Serial numbers: C01001, C01002, C01003, C01022, C01026, C01027, C01029, C01030, C01031, C01032, C01033, C01034, C01039, C01045, C01054, C01055, C01060, C01061, C01062, C01064, C01066, C01067, C01068, C01069, C01070, C01072, C01074, C01076, C01077, C01078, C01079, C01080, C01081, C01082, C01084, C01085, C01086, C01087, C01089, C01090, C01092, C01093, C01094, C01095, C01096, C01097, C01098, C01099, C01100, C01101, C01102, C01103, C01104, C01105, C01106, C01107, C01108, C01110, C01111, C01113, C01114, C01115, C01116, C01117, C01118, C01119, C01122, C01123, C01124, C01126, C01130, C01131, C01132, C01133, C01134, C01138, C01139, C01140, C01141, C01142, C01144, C01147, C01148, C01149, C01151, C01153, C01154, C01163, C01166, C01167, C01173, C01177, C01179, C01180, C01182, C01183, C01185, C01186, C01187, C01188, C01189, C01192, C01193, C01194, C01195, C01196, C01198, C01199, C01200, C01201, C01203, C01204, C01205, C01206, C01207, C01208, C01209, C01210, C01211, C01212, C01213, C01214, C01228, C01231, C01232, C01237, C01240, C01250, C01251, C01252, C01255, C01256, C01257, C01259, C01261, C01262, C01264, C01265, C01267, C01268, C01269, C01270, C01271, C01273, C01274, C01283, C01284, C01286, C01292, C01302, C01303, C01304, C01305, C01307, C01309, C01310, C01311, C01312, C01313, C01314, C01315, C01319, C01320, C01321, C01322, C01323, C01326, C01327, C01328, C01329, C01333, C01339, C01340, C01343, C01344, C01345, C01346, C01348, C01350, C01351, C01353, C01354, C01355, C01356, C01357, C01358, C01359, C01363, C01364, C01374, C01385, C01386, C01388, C01389, C01390, C01391, C01392, C01393, C01394, C01395, C01398, C01401, C01402, C01403, C01405, C01406, C01407, C01408, C01413, C01420, C01429, C01430, C01431, C01432, C01433, C01435, C01437, C01438, C01439, C01441, C01443, C01444, C01445, C01446, C01448, C01452, C01453, C01454, C01461, C01475, C01476, C01477, C01478, C01479, C01480, C01481, C01482, C01483, C01484, C01485, C01486, C01488, C01489, C01492, C01494, C01496, C01497, C01499, C01505, C01506, C01514, C01519, C01520, C01521, C01522, C01523, C01524, C01525, C01526, C01527, C01529, C01530, C01531, C01532, C01533, C01534, C01536, C01537, C01539, C01540, C01541, C01553, C01557, C01559, C01560, C01561, C01562, C01563, C01564, C01565, C01567, C01570, C01571, C01572, C01573, C01574, C01576, C01577, C01578, C01579, C01580, C01581, C01582, C01583, C01585, C01586, C01589, C01591, C01592, C01594, C01595, C01596, C01597, C01598, C01600, C01601, C01603, C01604, C01611, C01612, C01613, C01615, C01616, C01624, C01625, C01632, C01635, C01638, C01639, C01640, C01641, C01642, C01644, C01645, C01646, C01647, C01648, C01650, C01651, C01652, C01654, C01656, C01657, C01658, C01659, C01660, C01662, C01670, C01681, C01694, C01695, C01697, C01699, C01700, C01701, C01703, C01705, C01707, C01708, C01710, C01711, C01712, C01713, C01714, C01716, C01717, C01725, C01743, C01744, C01746, C01747, C01749, C01750, C01752, C01753, C01754, C01757, C01762, C01764, C01768, C01769, C01770, C01771, C01772, C01777, C01778, C01779, C01780, C01781, C01783, C01784, C01785, C01786, C01789, C01790, C01791, C01792, C01794, C01795, C01796, C01797, C01824, C01829, C01831, C01832, C01834, C01836, C01837, C01838, C01840, C01841, C01842, C01843, C01844, C01845, C01845, C01848, C01849, C01850, C01852, C01853, C01854, C01855, C01858, C01861, C01862, C01863, C01864, C01865, C01866, C01867, C01868, C01869, C01871, C01873, C01874, C01875, C01876, C01877, C01878, C01880, C01881, C01883, C01884, C01885, C01895, C01896, C01901, C01903, C01904, C01907, C01908, C01909, C01910, C01913, C01914, C01916, C01917, C01919, C01920, C01921, C01922, C01923, C01929, C01930, C01933, C01935, C01939, C01941, C01942, C01943, C01945, C01946, C01948, C01949, C01950, C01966, C01980, C01981, C01982, C01983, C01984, C01985, C01986, C01987, C01988, C01989, C01991, C01993, C01994, C01995, C01996, C01998, C01999, C02000, C02001, C02005, C02006, C02007, C02010, C02021, C02023, C02025, C02026, C02027, C02028, C02029, C02030, C02031, C02032, C02033, C02036, C02037, C02038, C02039, C02041, C02042, C02043, C02044, C02047, C02048, C02049, C02050, C02071, C02072, C02073, C02074, C02076, C02077, C02078, C02080, C02083, C02084, C02085, C02087, C02089, C02090, C02091, C02092, C02094, C02095, C02097, C02102, C02103, C02104, C02105, C02108, C02110, C02111, C02114, C02115, C02123, C02125, C02127, C02128, C02130, C02132, C02133, C02134, C02135, C02136, C02137, C02139, C02140, C02141, C02143, C02144, C02145, C02146, C02147, C02148, C02149, C02150, C02151, C02152, C02156, C02158, C02159, C02160, C02163, C02164, C02186, C02203, C02204, C02207, C02208, C02209, C02210, C02211, C02212, C02214, C02215, C02216, C02217, C02219, C02220, C02221, C02222, C02223, C02224, C02225, C02226, C02227, C02228, C02234, C02238, C02239, C02240, C02241, C02242, C02245, C02246, C02248, C02249, C02250, C02251, C02252, C02253, C02254, C02255, C02260, C02261, C02262, C02263, C02265, C02266, C02268, C02269, C02270, C02275, C02276, C02277, C02280, C02284, C02285, C02286, C02287, C02288, C02289, C02290, C02291, C02292, C02293, C02295, C02297, C02302, C02303, C02304, C02305, C02306, C02307, C02308, C02309, C02311, C02313, C02314, C02315, C02316, C02317, C02319, C02320, C02324, C02326, C02327, C02328, C02358, C02359, C02360, C02363, C02367, C02371, C02375, C02376, C02379, C02381, C02382, C02384, C02385, C02386, C02388, C02389, C02390, C02391, C02392, C02393, C02394, C02396, C02397, C02398, C02399, C02400, C02401, C02402, C02403, C02404, C02405, C02406, C02408, C02409, C02410, C02411, C02412, C02413, C02414, C02415, C02416, C02417, C02418, C02420, C02421, C02430, C02434, C02444, C02445, C02446, C02448, C02450, C02451, C02452, C02454, C02455, C02460, C02461, C02462, C02463, C02466, C02468, C02470, C02472, C02480, C02482, C02483, C02486, C02487, C02488, C02490, C02492, C02493, C02495, C02496, C02498, C02499, C02500, C02501, C02502, C02503, C02506, C02507, C02508, C02509, C02511, C02515, C02516, C02519, C02528, C02530, C02531, C02536, C02537, C02544, C02546, C02547, C02548, C02549, C02550, C02552, C02554, C02556, C02558, C02560, C02561, C02562, C02567, C02568, C02569, C02570, C02571, C02572, C02573, C02574, C02575, C02576, C02578, C02580, C02581, C02582, C02583, C02584, C02585, C02586, C02587, C02588, C02589, C02590, C02597, C02600, C02616, C02617, C02620, C02621, C02624, C02626, C02633, C02634, C02638, C02640, C02642, C02643, C02645, C02647, C02648, C02650, C02651, C02653, C02655, C02656, C02657, C02658, C02659, C02660, C02662, C02664, C02665, C02666, C02667, C02669, C02671, C02672, C02673, C02674, C02677, C02678, C02680, C02681, C02682, C02683, C02685, C02686, C02687, C02688, C02689, C02690, C02691, C02692, C02693, C02696, C02697, C02698, C02699, C02700, C02703, C02704, C02705, C02706, C02711, C02712, C02713, C02715, C02716, C02719, C02720, C02721, C02722, C02723, C02724, C02726, C02727, C02728, C02729, C02730, C02731, C02732, C02733, C02735, C02736, C02737, C02738, C02739, C02740, C02742, C02743, C02744, C02746, C02747, C02749, C02750, C02751, C02752, C02753, C02754, C02755, C02756, C02757, C02758, C02759, C02760, C02761, C02767, C02768, C02769, C02770, C02771, C02772, C02773, C02774, C02776, C02779, C02780, C02810, C02812, C02813, C02814, C02815, C02816, C02817, C02818, C02819, C02821, C02822, C02823, C02824, C02825, C02826, C02827, C02828, C02829, C02830, C02831, C02832, C02833, C02835, C02836, C02838, C02839, C02840, C02841, C02845, C02846, C02848, C02849, C02851, C02852, C02853, C02854, C02855, C02856, C02858, C02859, C02860, C02861, C02862, C02863, C02864, C02865, C02866, C02867, C02868, C02869, C02870, C02873, C02874, C02876, C02877, C02878, C02879, C02880, C02881, C02882, C02883, C02884, C02885, C02886, C02887, C02888, C02889, C02890, C02891, C02893, C02894, C02895, C02896, C02898, C02899, C02900, C02901, C02904, C02905, C02906, C02907, C02908, C02910, C02911, C02912, C02913, C02915, C02916, C02918, C02919, C02920, C02921, C02922, C02923, C02924, C02925, C02926, C02927, C02928, C02929, C02931, C02932, C02933, C02934, C02935, C02936, C02938, C02939, C02940, C02941, C02942, C02944, C02947, C02948, C02949, C02950, C02951, C02953, C02954, C02957, C02958, C02959, C02960, C02961, C02962, C02963, C02964, C02965, C02967, C02968, C02969, C02970, C02971, C02972, C02973, C02974, C02975, C02976, C02977, C02978, C02981, C02982, C02983, C02984, C02987, C02988, C02989, C02990, C02991, C02992, C02993, C02994, C02995, C02996, C02997, C02998, C02999, C03000, C03001, C03003, C03005, C03006, C03007, C03008, C03009, C03010, C03011, C03013, C03014, C03015, C03016, C03018, C03021, C03023, C03026, C03027, C03028, C03030, C03031, C03033, C03034, C03035, C03036, C03037, C03039, C03041, C03042, C03043, C03044, C03045, C03046, C03047, C03048, C03049, C03050, C03051, C03053, C03056, C03057, C03059, C03060, C03061, C03063, C03064, C03067, C03068, C03070, C03071, C03072, C03073, C03075, C03076, C03077, C03078, C03079, C03080, C03084, C03085, C03087, C03088, C03089, C03093, C03094, C03095, C03097, C03098, C03099, C03100, C03102, C03103, C03107, C03109, C03110, C03111, C03114, C03115, C03118, C03119, C03120, C03121, C03124, C03125, C03127, C03128, C03131, C03133, C03134, C03135, C03136, C03139, C03140, C03141, C03147, C03149, C03151, C03152, C03153, C03154, C03156, C03157, C03158, C03159, C03160, C03161, C03162, C03163, C03164, C03165, C03166, C03167, C03180, C03184, C03185, C03189, C03193, C03198, C03200, C03201, C03204, C03205, C03206, C03207, C03209, C03210, C03212, C03215, C03218, C03222, C03223, C03224, C03226, C03228, C03229, C03231, C03232, C03233, C03234, C03235, C03236, C03237, C03239, C03240, C03241, C03242, C03243, C03244, C03245, C03246, C03247, C03248, C03249, C03250, C03251, C03254, C03255, C03257, C03259, C03260, C03261, C03262, C03264, C03265, C03266, C03268, C03269, C03271, C03272, C03275, C03276, C03278, C03279, C03280, C03281, C03282, C03283, C03284, C03285, C03286, C03287, C03289, C03290, C03291, C03292, C03294, C03296, C03297, C03298, C03299, C03300, C03302, C03303, C03304, C03306, C03307, C03308, C03310, C03312, C03313, C03316, C03318, C03319, C03320, C03322, C03324, C03325, C03326, C03328, C03330, C03331, C03332, C03335, C03336, C03338, C03346, C03349, C03352, C03354, C03362, C03364, C03368, C03369, C03370, C03374, C03375, C03377, C03379, C03380, C03381, C03382, C03383, C03384, C03386, C03387, C03388, C03389, C03390, C03391, C03392, C03393, C03394, C03395, C03397, C03398, C03399, C03400, C03401, C03402, C03403, C03404, C03405, C03408, C03412, C03413, C03414, C03416, C03418, C03419, C03420, C03421, C03422, C03424, C03426, C03427, C03428, C03429, C03430, C03431, C03432, C03433, C03434, C03436, C03438, C03439, C03440, C03441, C03443, C03446, C03449, C03451, C03454, C03457, C03458, C03460, C03461, C03462, C03463, C03465, C03467, C03469, C03472, C03473, C03474, C03475, C03476, C03477, C03478, C03479, C03480, C03481, C03482, C03486, C03487, C03488, C03489, C03491, C03493, C03494, C03495, C03496, C03497, C03498, C03499, C03501, C03503, C03504, C03505, C03506, C03508, C03509, C03510, C03513, C03514, C03516, C03517, C03518, C03521, C03523, C03524, C03525, C03526, C03527, C03529, C03531, C03532, C03533, C03534, C03536, C03537, C03538, C03540, C03544, C03546, C03549, C03550, C03551, C03554, C03557, C03558, C03559, C03560, C03561, C03562, C03563, C03564, C03566, C03568, C03569, C03573, C03574, C03575, C03576, C03578, C03580, C03583, C03584, C03589, C03592, C03593, C03594, C03595, C03596, C03598, C03599, C03601, C03602, C03603, C03604, C03606, C03608, C03609, C03614, C03617, C03620, C03621, C03622, C03624, C03629, C03631, C03633, C03634, C03636, C03637, C03639, C03641, C03642, C03644, C03645, C03647, C03648, C03649, C03652, C03656, C03661, C03662, C03666, C03668, C03669, C03670, C03671, C03673, C03680, C03682, C03683, C03684, C03685, C03687, C03688, C03689, C03690, C03691, C03692, C03694, C03695, C03696, C03697, C03699, C03701, C03702, C03703, C03705, C03706, C03710, C03713, C03714, C03716, C03717, C03718, C03719, C03720, C03722, C03724, C03725, C03726, C03730, C03731, C03732, C03734, C03736, C03737, C03738, C03739, C03741, C03742, C03744, C03745, C03746, C03748, C03749, C03750, C03751, C03752, C03753, C03754, C03756, C03757, C03758, C03760, C03761, C03763, C03765, C03766, C03768, C03770, C03771, C03772, C03773, C03774, C03775, C03776, C03777, C03778, C03779, C03780, C03781, C03782, C03783, C03784, C03787, C03788, C03789, C03790, C03791, C03792, C03793, C03794, C03796, C03797, C03798, C03799, C03801, C03803, C03804, C03805, C03808, C03809, C03811, C03813, C03814, C03815, C03817, C03818, C03819, C03820, C03821, C03822, C03823, C03824, C03825, C03827, C03828, C03829, C03830, C03831, C03832, C03833, C03834, C03836, C03837, C03838, C03839, C03840, C03842, C03843, C03844, C03845, C03850, C03851, C03852, C03857, C03858, C03859, C03861, C03862, C03863, C03864, C03866, C03868, C03872, C03873, C03874, C03875, C03877, C03879, C03880, C03881, C03883, C03887, C03888, C03889, C03890, C03891, C03892, C03893, C03894, 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C07310, C07312, C07315, C07316, C07319, C07320, C07321, C07322, C07324, C07325, C07326, C07327, C07328, C07329, C07331, C07332, C07334, C07336, C07337, C07338, C07339, C07340, C07341, C07342, C07343, C07345, C07347, C07348, C07349, C07351, C07353, C07354, C07355, C07357, C07358, C07359, C07360, C07361, C07362, C07363, C07364, C07366, C07367, C07368, C07369, C07371, C07372, C07373, C07374, C07375, C07376, C07377, C07379, C07380, C07381, C07382, C07383, C07384, C07386, C07388, C07389, C07390, C07392, C07393, C07394, C07395, C07396, C07398, C07399, C07400, C07401, C07403, C07404, C07405, C07407, C07408, C07409, C07410, C07411, C07412, C07413, C07415, C07416, C07417, C07418, C07419, C07420, C07421, C07422, C07423, C07424, C07425, C07426, C07427, C07429, C07430, C07431, C07432, C07434, C07436, C07437, C07438, C07440, C07441, C07442, C07444, C07446, C07448, C07449, C07452, C07454, C07455, C07460, C07461, C07462, C07463, C07464, C07465, C07466, C07467, C07468, C07469, C07470, C07472, C07474, 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C07829, C07835, C07870, C07880, C07881, C07883, C07884, C07886, C07887, C07889, C07890, C07891, C07892, C07893, C07894, C07895, C07896, C07897, C07898, C07899, C07900, C07901, C07902, C07903, C07904, C07905, C07906, C07907, C07908, C07909, C07910, C07911, C07913, C07914, C07915, C07916, C07917, C07918, C07919, C07921, C07922, C07924, C07925, C07927, C07928, C07929, C07930, C07931, C07932, C07933, C07934, C07936, C07937, C07938, C07939, C07940, C07941, C07942, C07943, C07944, C07945, C07946, C07947, C07949, C07950, C07951, C07952, C07953, C07954, C07957, C07958, C07959, C07960, C07961, C07962, C07963, C07964, C07965, C07966, C07967, C07968, C07970, C07971, C07973, C07974, C07976, C07977, C07978, C07979, C07980, C07981, C07982, C07983, C07984, C07985, C07986, C07988, C07990, C07991, C07992, C07993, C07994, C07995, C07996, C07997, C07998, C07999, C08001, C08002, C08003, C08004, C08005, C08023, C08025, C08035, C08036, C08039, C08044, C08045, C08048, C08055, C08060, C08062, C08063, C08064, 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C08203, C08205, C08206, C08207, C08208, C08209, C08210, C08211, C08212, C08213, C08214, C08215, C08216, C08217, C08218, C08219, C08220, C08221, C08222, C08223, C08224, C08226, C08227, C08228, C08229, C08230, C08231, C08233, C08234, C08235, C08237, C08238, C08240, C08241, C08242, C08244, C08245, C08247, C08248, C08249, C08250, C08251, C08252, C08253, C08254, C08255, C08256, C08257, C08258, C08259, C08260, C08261, C08262, C08263, C08264, C08265, C08266, C08267, C08268, C08269, C08272, C08273, C08274, C08275, C08276, C08277, C08278, C08279, C08280, C08282, C08283, C08284, C08285, C08287, C08289, C08290, C08291, C08292, C08295, C08296, C08297, C08298, C08299, C08300, C08302, C08304, C08305, C08307, C08308, C08309, C08310, C08314, C08315, C08316, C08317, C08319, C08320, C08321, C08323, C08324, C08325, C08326, C08328, C08335, C08338, C08343, C08347, C08352, C08353, C08357, C08359, C08360, C08362, C08363, C08367, C08369, C08370, C08371, C08372, C08373, C08374, C08377, C08378, C08379, C08383, C08384, C08385, C08386, C08387, C08388, C08390, C08391, C08393, C08394, C08395, C08397, C08398, C08399, C08400, C08401, C08402, C08403, C08404, C08406, C08407, C08408, C08409, C08410, C08412, C08413, C08415, C08417, C08418, C08419, C08420, C08421, C08422, C08423, C08424, C08425, C08426, C08427, C08428, C08429, C08430, C08431, C08432, C08433, C08434, C08435, C08436, C08437, C08438, C08439, C08440, C08441, C08442, C08443, C08444, C08445, C08446, C08447, C08448, C08449, C08450, C08451, C08452, C08453, C08454, C08455, C08456, C08457, C08458, C08459, C08460, C08461, C08463, C08464, C08465, C08466, C08467, C08468, C08469, C08470, C08471, C08472, C08473, C08474, C08475, C08476, C08477, C08478, C08479, C08480, C08481, C08482, C08483, C08484, C08485, C08486, C08488, C08489, C08490, C08491, C08492, C08493, C08494, C08496, C08497, C08498, C08499, C08500, C08501, C08502, C08503, C08504, C08505, C08506, C08507, C08508, C08509, C08510, C08511, C08512, C08514, C08515, C08516, C08517, C08518, C08519, C08521, C08522, C08523, C08524, C08525, C08527, C08528, C08529, C08532, C08533, C08535, C08536, C08537, C08546, C08550, C08551, C08552, C08553, C08554, C08555, C08556, C08557, C08558, C08559, C08560, C08561, C08562, C08563, C08564, C08565, C08566, C08567, C08568, C08569, C08570, C08571, C08572, C08573, C08574, C08575, C08576, C08577, C08578, C08579, C08581, C08582, C08583, C08584, C08585, C08587, C08588, C08589, C08590, C08591, C08592, C08593, C08594, C08595, C08596, C08597, C08598, C08599, C08600, C08601, C08602, C08603, C08604, C08605, C08606, C08607, C08610, C08615, C08620, C08648, C08650, C08651, C08652, C08653, C08654, C08655, C08656, C08657, C08658, C08659, C08660, C08661, C08662, C08663, C08664, C08665, C08666, C08667, C08668, C08669, C08670, C08671, C08672, C08673, C08674, C08675, C08676, C08677, C08678, C08679, C08680, C08681, C08684, C08685, C08686, C08687, C08688, C08689, C08690, C08691, C08693, C08694, C08695, C08697, C08704, C08706, C08707, C08714, C08715, C08718, C08719, C08720, C08724, C08728, C08729, C08732, C08733, C08734, C08738, C08739, C08746, C08749, C08750, C08752, C08755, C08765, C08766, C08767, C08768, C08769, C08770, C08771, C08772, C08773, C08774, C08775, C08776, C08777, C08780, C08781, C08783, C08784, C08785, C08787, C08789, C08790, C08791, C08792, C08793, C08794, C08795, C08796, C08797, C08799, C08801, C08802, C08804, C08805, C08806, C08807, C08808, C08809, C08810, C08813, C08814, C08819, C08823, C08825, C08828, C08829, C08830, C08831, C08832, C08833, C08834, C08836, C08838, C08840, C08841, C08842, C08843, C08844, C08846, C08847, C08848, C08849, C08851, C08852, C08853, C08854, C08857, C08858, C08859, C08860, C08861, C08862, C08863, C08864, C08865, C08866, C08867, C08868, C08869, C08870, C08872, C08873, C08874, C08875, C08876, C08877, C08878, C08879, C08880, C08882, C08883, C08884, C08885, C08886, C08887, C08888, C08889, C08890, C08892, C08893, C08894, C08895, C08897, C08898, C08900, C08901, C08902, C08903, C08904, C08906, C08907, C08908, C08909, C08910, C08911, C08912, C08913, C08914, C08915, C08916, C08917, C08918, C08919, C08920, C08922, C08924, C08925, C08926, C08928, C08929, C08930, C08932, C08933, C08934, C08939, C08940, C08941, C08942, C08943, C08944, C08945, C08946, C08947, C08948, C08949, C08951, C08952, C08953, C08956, C08960, C08961, C08962, C08965, C08967, C08968, C08970, C08972, C08973, C08974, C08976, C08979, C08981, C08982, C08984, C08985, C08986, C08987, C08988, C08989, C08990, C08991, C08993, C08995, C08996, C08997, C08998, C08999, C09001, C09002, C09003, C09004, C09005, C09006, C09007, C09008, C09009, C09011, C09013, C09014, C09015, C09016, C09017, C09018, C09020, C09021, C09022, C09023, C09024, C09025, C09026, C09027, C09029, C09030, C09031, C09032, C09033, C09037, C09040, C09042, C09047, C09050, C09052, C09054, C09055, C09057, C09060, C09061, C09062, C09063, C09064, C09065, C09066, C09067, C09069, C09070, C09071, C09072, C09073, C09074, C09075, C09076, C09077, C09078, C09079, C09080, C09082, C09083, 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C10991, C10992, C10993, C10994, C10995, C10996, C10997, C10998, C10999, C11000, C11001, C11002, C11003, C11004, C11005, C11006, C11007, C11008, C11009, C11010, C11011, C11012, C11013, C11014, C11015, C11016, C11017, C11018, C11019, C11020, C11021, C11022, C11023, C11024, C11025, C11026, C11027, C11028, C11029, C11030, C11031, C11032, C11033, C11035, C11036, C11037, C11038, C11039, C11040, C11041, C11042, C11043, C11044, C11045, C11046, C11047, C11048, C11049, C11050, C11051, C11052, C11053, C11054, C11055, C11056, C11057, C11058, C11059, C11060, C11061, C11062, C11063, C11064, C11065, C11066, C11067, C11068, C11069, C11070, C11071, C11072, C11073, C11074, C11075, C11076, C11077, C11078, C11079, C11080, C11081, C11082, C11083, C11084, C11085, C11086, C11087, C11088, C11089, C11090, C11091, C11092, C11093, C11095, C11096, C11097, C11098, C11099, C11100, C11101, C11102, C11103, C11104, C11105, C11106, C11107, C11108, C11109, C11110, C11111, C11112, C11113, C11114, C11115, C11116, C11117, C11118, C11119, C11120, C11121, C11122, C11124, C11125, C11126, C11127, C11128, C11129, C11130, C11131, C11132, C11133, C11134, C11135, C11137, C11138, C11139, C11140, C11141, C11142, C11143, C11144, C11145, C11146, C11147, C11148, C11149, C11150, C11151, C11152, C11153, C11154, C11155, C11156, C11157, C11158, C11159, C11160, C11161, C11162, C11163, C11164, C11165, C11166, C11167, C11168, C11169, C11170, C11171, C11172, C11174, C11175, C11176, C11177, C11178, C11179, C11180, C11181, C11182, C11184, C11185, C11186, C11188, C11189, C11190, C11191, C11192, C11193, C11194, C11195, C11196, C11197, C11198, C11199, C11200, C11201, C11202, C11204, C11205, C11206, C11207, C11208, C11209, C11211, C11212, C11213, C11214, C11215, C11216, C11217, C11218, C11219, C11220, C11221, C11222, C11223, C11224, C11225, C11226, C11227, C11228, C11229, C11230, C11231, C11232, C11233, C11234, C11235, C11236, C11237, C11238, C11240, C11241, C11242, C11243, C11244, C11245, C11246, C11247, C11248, C11249, C11250, C11251, C11252, C11253, C11254, C11255, C11256, C11257, C11258, C11259, C11260, C11261, C11263, C11264, C11265, C11266, C11267, C11268, C11269, C11270, C11271, C11272, C11276, C11277, C11278, C11279, C11280, C11281, C11282, C11283, C11284, C11285, C11286, C11287, C11288, C11289, C11290, C11291, C11352, C11353, C11354, C11355, C11356, C11357, C11358, C11359, C11360, C11361, C11362, C11363, C11364, C11365, C11366, C11367, C11368, C11369, C11370, C11371, C11372, C11373, C11374, C11375, C11376, C11377, C11378, C11379, C11380, C11382, C11383, C11384, C11385, C11386, C11387, C11388, C11389, C11390, C11391, C11392, C11393, C11394, C11395, C11396, C11397, C11398, C11400, C11401, C11402, C11403, C11404, C11406, C11407, C11408, C11409, C11410, C11411, C11412, C11432, C11579, C11626, C11743, C11744, C11747, C11842, C12012, C14890, C15138, C15422, C15424, C15505, C15506
c) Serial numbers: B01012, B01052, B01053, B01056, B01060, B01062, B01064, B01066, B01068, B01074, B01075, B01076, B01077, B01079, B01080, B01082, B01083, B01084, B01085, B01086, B01087, B01089, B01091, B01092, B01093, B01094, B01095, B01096, B01099, B01100, B01101, B01102, B01103, B01104, B01105, B01106, B01107, B01108, B01109, B01112, B01114, B01115, B01118, B01121, B01123, B01125, B01129, B01130, B01131, B01132, B01134, B01137, B01140, B01144, B01147, B01148, B01149, B01151, B01152, B01156, B01159, B01161, B01162, B01163, B01165, B01167, B01169, B01171, B01172, B01174, B01175, B01176, B01177, B01180, B01184, B01185, B01186, B01187, B01188, B01189, B01190, B01191, B01193, B01195, B01198, B01200, B01201, B01202, B01203, B01205, B01206, B01207, B01210, B01216, B01223, B01230, B01232, B01236, B01238, B01239, B01240, B01243, B01244, B01251, B01252, B01256, B01259, B01260, B01262, B01263, B01265, B01266, B01267, B01268, B01269, B01270, B01271, B01272, B01273, B01276, B01277, B01278, B01280, B01283, B01284, B01285, B01287, B01288, B01289, B01290, B01292, B01294, B01295, B01296, B01297, B01298, B01299, B01301, B01302, B01303, B01304, B01305, B01307, B01309, B01312, B01314, B01316, B01317, B01318, B01320, B01321, B01322, B01324, B01327, B01329, B01330, B01331, B01334, B01335, B01336, B01339, B01341, B01342, B01343, B01344, B01345, B01346, B01347, B01348, B01349, B01350, B01354, B01357, B01358, B01359, B01364, B01365, B01367, B01368, B01369, B01370, B01375, B01376, B01377, B01383, B01388, B01389, B01390, B01391, B01393, B01394, B01395, B01396, B01397, B01399, B01401, B01403, B01404, B01406, B01409, B01410, B01414, B01416, B01417, B01418, B01422, B01423, B01425, B01426, B01428, B01430, B01431, B01432, B01433, B01434, B01436, B01437, B01438, B01442, B01443, B01444, B01445, B01449, B01450, B01454, B01455, B01457, B01458, B01459, B01461, B01463, B01464, B01465, B01466, B01467, B01468, B01469, B01470, B01474, B01475, B01476, B01477, B01478, B01480, B01481, B01485, B01487, B01488, B01491, B01492, B01493, B01494, B01495, B01496, B01500, B01501, B01505, B01507, B01508, B01512, B01514, B01515, B01518, B01520, B01523, B01525, B01526, B01527, B01528, B01529, B01531, B01533, B01534, B01536, B01537, B01539, B01540, B01542, B01544, B01545, B01546, B01550, B01552, B01553, B01554, B01555, B01556, B01558, B01563, B01564, B01567, B01569, B01570, B01572, B01573, B01574, B01575, B01579, B01585, B01586, B01587, B01588, B01589, B01590, B01591, B01592, B01594, B01598, B01599, B01600, B01601, B01604, B01607, B01610, B01611, B01612, B01613, B01616, B01617, B01619, B01620, B01621, B01623, B01625, B01625, B01629, B01633, B01636, B01637, B01638, B01639, B01641, B01643, B01646, B01649, B01651, B01652, B01655, B01656, B01659, B01661, B01663, B01664, B01666, B01667, B01668, B01669, B01671, B01672, B01673, B01674, B01675, B01676, B01679, B01680, B01682, B01686, B01687, B01689, B01691, B01692, B01693, B01694, B01699, B01700, B01702, B01703, B01704, B01705, B01706, B01707, B01708, B01709, B01711, B01712, B01715, B01716, B01718, B01721, B01722, B01723, B01724, B01728, B01730, B01731, B01732, B01733, B01742, B01744, B01745, B01747, B01748, B01749, B01750, B01751, B01753, B01754, B01755, B01758, B01760, B01762, B01763, B01767, B01769, B01770, B01774, B01777, B01779, B01781, B01783, B01784, B01785, B01786, B01787, B01788, B01789, B01790, B01791, B01793, B01794, B01796, B01797, B01798, B01799, B01800, B01801, B01803, B01805, B01806, B01807, B01808, B01810, B01811, B01812, B01814, B01815, B01829, B01831, B01832, B01833, B01836, B01837, B01838, B01840, B01841, B01843, B01844, B01845, B01846, B01847, B01848, B01849, B01850, B01851, B01852, B01855, B01873, B01875, B01876, B01877, B01878, B01879, B01880, B01883, B01885, B01886, B01888, B01889, B01890, B01892, B01893, B01894, B01895, B01896, B01898, B01899, B01900, B01903, B01905, B01906, B01907, B01908, B01909, B01911, B01914, B01916, B01917, B01918, B01919, B01921, B01924, B01925, B01926, B01928, B01930, B01933, B01934, B01936, B01938, B01940, B01941, B01943, B01945, B01946, B01949, B01950, B01955, B01958, B01959, B01960, B01961, B01962, B01964, B01965, B01966, B01967, B01968, B01971, B01972, B01973, B01975, B01976, B01977, B01979, B01982, B01983, B01984, B01986, B01988, B01989, B01990, B01991, B01992, B01993, B01994, B01995, B01998, B02000, B02002, B02003, B02005, B02007, B02008, B02009, B02011, B02012, B02013, B02014, B02016, B02017, B02018, B02019, B02020, B02021, B02022, B02023, B02024, B02025, B02027, B02029, B02030, B02031, B02032, B02034, B02036, B02039, B02040, B02044, B02045, B02046, B02047, B02049, B02050, B02051, B02052, B02054, B02056, B02057, B02061, B02062, B02063, B02064, B02067, B02068, B02071, B02074, B02075, B02076, B02077, B02078, B02079, B02081, B02082, B02084, B02085, B02086, B02090, B02091, B02092, B02097, B02098, B02099, B02101, B02102, B02103, B02106, B02110, B02111, B02112, B02113, B02115, B02116, B02117, B02118, B02119, B02120, B02121, B02122, B02123, B02124, B02125, B02126, B02127, B02128, B02129, B02130, B02131, B02132, B02133, B02134, B02135, B02136, B02137, B02142, B02145, B02148, B02149, B02150, B02151, B02152, B02153, B02156, B02157, B02159, B02160, B02162, B02163, B02164, B02165, B02166, B02167, B02168, B02169, B02170, B02171, B02172, B02173, B02174, B02175, B02176, B02177, B02178, B02179, B02180, B02182, B02183, B02184, B02185, B02186, B02188, B02189, B02191, B02193, B02195, B02197, B02198, B02199, B02200, B02201, B02202, B02203, B02205, B02206, B02209, B02210, B02211, B02213, B02214, B02216, B02217, B02222, B02223, B02227, B02228, B02229, B02230, B02231, B02235, B02238, B02241, B02242, B02243, B02244, B02245, B02246, B02248, B02249, B02250, B02253, B02260, B02262, B02263, B02266, B02267, B02268, B02269, B02270, B02271, B02274, B02275, B02276, B02277, B02278, B02279, B02280, B02281, B02282, B02283, B02284, B02286, B02287, B02288, B02292, B02293, B02294, B02296, B02297, B02298, B02300, B02301, B02303, B02305, B02307, B02308, B02313, B02315, B02316, B02317, B02319, B02320, B02321, B02323, B02324, B02327, B02328, B02330, B02333, B02334, B02335, B02336, B02337, B02339, B02342, B02344, B02346, B02348, B02349, B02350, B02351, B02352, B02353, B02354, B02355, B02356, B02357, B02358, B02359, B02360, B02361, B02363, B02365, B02366, B02367, B02369, B02370, B02371, B02374, B02376, B02378, B02379, B02380, B02382, B02388, B02392, B02393, B02394, B02395, B02396, B02397, B02398, B02399, B02402, B02405, B02406, B02409, B02410, B02411, B02412, B02414, B02416, B02420, B02421, B02423, B02425, B02427, B02428, B02429, B02431, B02436, B02438, B02439, B02444, B02445, B02446, B02449, B02450, B02451, B02453, B02455, B02456, B02457, B02458, B02459, B02460, B02461, B02462, B02465, B02466, B02467, B02469, B02470, B02471, B02472, B02473, B02474, B02475, B02476, B02477, B02478, B02479, B02480, B02481, B02482, B02483, B02485, B02486, B02490, B02491, B02492, B02493, B02496, B02497, B02498, B02499, B02500, B02501, B02502, B02503, B02505, B02506, B02507, B02508, B02509, B02510, B02512, B02513, B02514, B02515, B02517, B02518, B02519, B02520, B02521, B02522, B02525, B02526, B02527, B02528, B02530, B02531, B02532, B02533, B02534, B02535, B02536, B02537, B02538, B02539, B02541, B02542, B02543, B02544, B02545, B02546, B02548, B02550, B02551, B02552, B02553, B02554, B02559, B02560, B02561, B02562, B02563, B02564, B02565, B02567, B02568, B02569, B02571, B02580, B02581, B02582, B02583, B02586, B02587, B02589, B02593, B02595, B02597, B02598, B02599, B02600, B02601, B02602, B02603, B02605, B02606, B02607, B02608, B02609, B02611, B02612, B02613, B02614, B02616, B02617, B02619, B02620, B02621, B02622, B02623, B02625, B02628, B02629, B02630, B02631, B02632, B02633, B02634, B02635, B02636, B02637, B02639, B02640, B02641, B02642, B02644, B02645, B02646, B02648, B02649, B02651, B02652, B02654, B02655, B02656, B02657, B02658, B02659, B02660, B02661, B02662, B02663, B02664, B02665, B02666, B02668, B02669, B02671, B02672, B02673, B02675, B02676, B02678, B02680, B02682, B02685, B02686, B02687, B02689, B02690, B02691, B02694, B02695, B02696, B02699, B02704, B02705, B02706, B02707, B02709, B02713, B02715, B02716, B02717, B02718, B02720, B02721, B02722, B02723, B02725, B02726, B02727, B02728, B02732, B02733, B02735, B02738, B02742, B02746, B02748, B02749, B02750, B02752, B02753, B02756, B02758, B02759, B02760, B02761, B02762, B02764, B02768, B02772, B02775, B02776, B02777, B02778, B02780, B02781, B02782, B02783, B02784, B02786, B02787, B02788, B02789, B02790, B02791, B02792, B02793, B02795, B02797, B02798, B02799, B02801, B02802, B02803, B02805, B02807, B02808, B02809, B02810, B02811, B02814, B02815, B02816, B02818, B02820, B02821, B02822, B02823, B02824, B02825, B02826, B02827, B02829, B02831, B02832, B02833, B02837, B02839, B02840, B02841, B02843, B02844, B02847, B02850, B02851, B02852, B02853, B02856, B02857, B02858, B02859, B02861, B02862, B02863, B02866, B03000, B03001, B03003, B03004, B03005, B03006, B03007, B03010, B03012, B03013, B03014, B03015, B03016, B03017, B03018, B03021, B03023, B03024, B03030, B03031, B03035, B03037, B03038, B03039, B03040, B03041, B03042, B03043, B03044, B03045, B03046, B03048, B03052, B03053, B03055, B03058, B03063, B03064, B03065, B03066, B03067, B03068, B03070, B03071, B03072, B03073, B03077, B03078, B03079, B03081, B03083, B03086, B03088, B03090, B03091, B03092, B03093, B03094, B03097, B03098, B03099, B03101, B03103, B03104, B03105, B03106, B03108, B03109, B03111, B03112, B03114, B03115, B03116, B03118, B03119, B03121, B03123, B03124, B03127, B03129, B03130, B03131, B03133, B03134, B03135, B03137, B03138, B03141, B03142, B03143, B03144, B03145, B03146, B03147, B03149, B03150, B03151, B03152, B03157, B03159, B03160, B03163, B03164, B03165, B03166, B03167, B03168, B03169, B03170, B03171, B03172, B03173, B03174, B03175, B03503, B03508, B03521, B03525, B03526, B03529, B03530, B03536, B03537, B03538, B03540, B03541, B03542, B03543, B03544, B03545, B03546, B03548, B03549, B03550, B03551, B03552, B03553, B03554, B03555, B03556, B03557, B03558, B03559, B03560, B03561, B03562, B03564, B03566, B03568, B03572, B03574, B03575, B03577, B03578, B03579, B03580, B03581, B03582, B03583, B03584, B03585, B03586, B03587, B03588, B03589, B03590, B03591, B03593, B03594, B03595, B03596, B03599, B03600, B03601, B03602, B03603, B03604, B03605, B03606, B03607, B03608, B03609, B03611, B03612, B03613, B03614, B03615, B03616, B03618, B03619, B03620, B03621, B03622, B03623, B03625, B03626, B03627, B03628, B03629, B03630, B03631, B03632, B03633, B03634, B03635, B03636, B03637, B03638, B03639, B03640, B03641, B03643, B03644, B03645, B03646, B03647, B03648, B03649, B03651, B03653, B03654, B03655, B03656, B03658, B03659, B03660, B03661, B03663, B03664, B03666, B03667, B03668, B03669, B03670, B03671, B03673, B03674, B03675, B03676, B03677, B03678, B03679, B03680, B03681, B03684, B03685, B03686, B03687, B03688, B03689, B03690, B03692, B03693, B03695, B03696, B03697, B03698, B03699, B03700, B03701, B03703, B03704, B03705, B03706, B03707, B03709, B03710, B03711, B03712, B03713, B03714, B03718, B03719, B03720, B03721, B03722, B03723, B03724, B03725, B03727, B03729, B03730, B03731, B03732, B03733, B03734, B03735, B03736, B03738, B03739, B03741, B03743, B03745, B03746, B03747, B03748, B03749, B03750, B03751, B03752, B03753, B03754, B03755, B03756, B03758, B03759, B03760, B03761, B03762, B03763, B03764, B03765, B03766, B03767, B03768, B03769, B03770, B03771, B03772, B03773, B03774, B03775, B03776, B03777, B03778, B03779, B03780, B03781, B03782, B03783, B03784, B03785, B03786, B03788, B03789, B03790, B03791, B03792, B03793, B03794, B03795, B03797, B03798, B03799, B03800, B03801, B03802, B03803, B03804, B03805, B03806, B03807, B03808, B03810, B03811, B03812, B03813, B03814, B03815, B03816, B03817, B03819, B03820, B03821, B03822, B03823, B03825, B03826, B03827, B03828, B03829, B03831, B03832, B03833, B03834, B03835, B03836, B03837, B03838, B03839, B03840, B03841, B03842, B03843, B03844, B03845, B03846, B03847, B03848, B03849, B03850, B03852, B03853, B03854, B03855, B03856, B03857, B03858, B03859, B03860, B03862, B03863, B03864, B03865, B03867, B03869, B03870, B03871, B03872, B03873, B03874, B03875, B03876, B03877, B03878, B03879, B03880, B03882, B03883, B03884, B03886, B03887, B03888, B03889, B03890, B03891, B03892, B03893, B03894, B03895, B03896, B03897, B03898, B03899, B03900, B03901, B03902, B03903, B03904, B03905, B03906, B03907, B03908, B03909, B03910, B03911, B03912, B03913, B03914, B03915, B03916, B03917, B03918, B03919, B03921, B03922, B03923, B03924, B03925, B03926, B03927, B03928, B03929, B03930, B03931, B03933, B03934, B03935, B03936, B03937, B03938, B03939, B03940, B03941, B03942, B03943, B03944, B03945, B03946, B03947, B03949, B03950, B03952, B03953, B03954, B03956, B03957, B03958, B03959, B03960, B03961, B03962, B03963, B03964, B03965, B03966, B03967, B03969, B03970, B03971, B03972, B03973, B03974, B03975, B03976, B03977, B03978, B03979, B03980, B03981, B03982, B03984, B03985, B03986, B03987, B03988, B03989, B03990, B03991, B03992, B03993, B03995, B03996, B03997, B04014, B04015, B04016, B04017, B04018, B04019, B04020, B04021, B04022, B04023, B04024, B04025, B04026, B04027, B04028, B04029, B04030, B04031, B04032, B04033, B04034, B04035, B04036, B04037, B04038, B04039, B04040, B04041, B04042, B04043, B04044, B04045, B04046, B04047, B04048, B04049, B04050, B04051, B04052, B04053, B04054, B04055, B04056, B04057, B04058, B04059, B04060, B04061, B04062, B04063, B04064, B04065, B04066, B04067, B04068, B04069, B04070, B04071, B04072, B04073, B04074, B04075, B04076, B04077, B04078, B04079, B04080, B04081, B04082, B04083, B04084, B04085, B04086, B04087, B04088, B04089, B04090, B04091, B04092, B04093, B04094, B04095, B04096, B04097, B04098, B04099, B04101, B04102, B04103, B04104, B04105, B04106, B04107, B04108, B04109, B04110, B04111, B04112, B04113, B04114, B04115, B04116, B04117, B04118, B04119, B04120, B04121, B04122, B04123, B04124, B04125, B04126, B04127, B04128, B04129, B04130, B04131, B04132, B04133, B04134, B04135, B04136, B04137, B04138, B04139, B04140, B04141, B04142, B04143, B04144, B04145, B04146, B04147, B04148, B04150, B04151, B04152, B04153, B04154, B04155, B04156, B04157, B04158, B04159, B04160, B04161, B04162, B04163, B04164, B04165, B04166, B04167, B04168, B04169, B04170, B04171, B04172, B04173, B04175, B04176, B04177, B04178, B04179, B04180, B04181, B04182, B04183, B04184, B04185, B04186, B04187, B04188, B04189, B04190, B04191, B04192, B04193, B04194, B04195, B04196, B04197, B04198, B04199, B04200, B04201, B04202, B04203, B04204, B04205, B04206, B04207, B04208, B04209, B04210, B04211, B04212, B04213, B04214, B04215, B04216, B04217, B04218, B04219, B04220, B04221, B04222, B04223, B04224, B04225, B04227, B04228, B04230, B04231, B04232, B04233, B04234, B04235, B04236, B04237, B04238, B04239, B04240, B04241, B04242, B04243, B04244, B04245, B04246, B04247, B04248, B04249, B04250, B04251, B04252, B04253, B04254, B04255, B04256, B04257, B04258, B04259, B04260, B04261, B04262, B04263, B04264, B04265, B04266, B04267, B04268, B04269, B04270, B04271, B04272, B04273, B04274, B04275, B04276, B04277, B04278, B04279, B04280, B04281, B04282, B04283, B04284, B04285, B04286, B04287, B04288, B04289, B04290, B04291, B04292, B04293, B04294, B04295, B04296, B04297, B04298, B04299, B04301, B04302, B04303, B04304, B04305, B04306, B04307, B04308, B04309, B04310, B04317;
d) Serial numbers: D01002, D01004, D01005, D01006, D01007, D01011, D01013, D01014, D01015, D01016, D01017, D01018, D01019, D01024, D01025, D01026, D01027, D01031, D01033, D01034, D01035, D01037, D01038, D01040, D01043, D01044, D01045, D01046, D01048, D01049, D01051, D01053, D01055, D01056, D01060, D01066, D01067, D01068, D01069, D01070, D01071, D01072, D01074, D01075, D01076, D01078, D01079, D01080, D01083, D01084, D01086, D01087, D01091, D01092, D01094, D01096, D01097, D01098, D01099, D01100, D01103, D01104, D01106, D01107, D01108, D01111, D01113, D01114, D01118, D01121, D01122, D01124, D01125, D01126, D01127, D01130, D01131, D01133, D01136, D01137, D01138, D01139, D01140, D01142, D01144, D01145, D01147, D01149, D01152, D01153, D01154, D01157, D01162, D01165, D01166, D01168, D01169, D01170, D01172, D01173, D01174, D01175, D01176, D01177, D01179, D01181, D01183, D01185, D01186, D01187, D01189, D01190, D01191, D01192, D01193, D01194, D01195, D01196, D01197, D01198, D01199, D01300, D01301, D01302, D01303, D01304, D01306, D01307, D01308, D01309, D01310, D01311, D01312, D01313, D01316, D01317, D01318, D01319, D01320, D01321, D01324, D01325, D01326, D01329, D01330, D01332, D01335, D01336, D01400, D01401, D01402, D01403, D01404, D01405, D01406, D01407, D01408, D01409, D01410, D01411, D01412, D01413, D01414, D01415, D01417, D01418, D01419, D01420, D01421, D01423, D01424, D01425, D01426, D01427, D01428, D01430, D01432, D01434, D01435, D01436, D01437, D01438, D01439, D01440, D01441, D01442, D01443, D01444, D01445, D01446, D01447, D01448, D01449, D01450, D01451, D01452, D01453, D01454, D01455, D01456, D01457, D01458, D01460, D01461, D01462, D01464, D01465, D01466, D01467, D01468, D01470, D01471, D01472, D01473, D01474, D01475, D01476, D01477, D01478, D01479, D01480, D01481, D01482, D01483, D01484, D01485, D01486, D01487, D01488, D01489, D01490, D01491, D01492, D01493, D01494, D01495, D01496, D01497, D01499, D01500, D01501, D01502, D01505, D01506, D01507, D01508, D01509, D01510, D01511, D01512, D01513, D01514, D01515, D01516, D01517, D01518, D01519, D01520, D01521, D01522, D01523, D01524, D01525, D01526, D01527, D01528, D01529, D01530, D01531, D01532, D01533, D01534, D01535, D01536, D01537, D01538, D01539, D01540, D01541, D01542, D01543, D01544, D01545, D01546, D01547, D01548, D01549, D01550, D01551, D01552, D01553, D01554, D01555, D01556, D01557, D01558, D01559, D01560, D01561, D01562, D01563, D01564, D01565, D01566, D01567, D01568, D01569, D01570, D01571, D01572, D01573, D01574, D01575, D01576, D01577, D01578, D01579, D01580, D01581, D01582, D01583, D01584, D01585, D01586, D01587, D01588, D01589, D01590, D01591, D01592, D01593, D01594, D01595, D01596, D01597, D01598, D01599;
e) Lot number: PWRRK0324502, PWRRK0327403, PWRRK0334402, PWRRK0336401, PWRRK0402801, PWRRK0405015, PWRRK0406201, PWRRK0408407, PWRRK0419801, PWRRK0427307, PWRRK0429501, PWRRK0430301, PWRRK0434102, PWRRK0435701, PWRRK0501302, PWRRK0505404, PWRRK0515203, PWRRK0516001, PWRRK0526901, PWRRK0527803,
f) Lot number: RKPWR0323911, RKPWR0325801, RKPWR0326802, RKPWR0328802, RKPWR0329504, RKPWR0330701, RKPWR0331801, RKPWR0334504, RKPWR0416008, RKPWR0420104, RKPWR0423903, RKPWR0430201, RKPWR0430803, RKPWR0434902, RKPWR0435702, RKPWR0502401, RKPWR0503901, RKPWR0504602, RKPWR0505403, RKPWR0506601, RKPWR0507701, RKPWR0508211, RKPWR0509501, RKPWR0510302, RKPWR0510803, RKPWR0511501, RKPWR0511904, RKPWR0514312, RKPWR0515202, RKPWR0516002, RKPWR0516602, RKPWR0519302, RKPWR0525802
g) Lot number: PWRMK0325902, PWRMK0407201, PWRMK0420105, PWRMK0436501, PWRMK0501101, PWRMK0504603, PWRMK0505402, PWRMK0506602, PWRMK0510303, PWRMK0510804, PWRMK0512201, PWRMK0512303, PWRMK0514313, PWRMK0515201, PWRMK0515701, PWRMK0517802, PWRMK0518701, PWRMK0526503;
h) Lot number: UK0335101, UK0400602, UK0404202, UK0408406, UK0410704, UK0412510, UK0424602, UK0427801, UK0430110, UK0433602, UK0504203, UK0508201
RECALLING FIRM/MANUFACTURER
Cardinal Health 203, Inc., Minneapolis, MN,
REASON
The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
VOLUME OF PRODUCT IN COMMERCE
14,034 ventilators and 6,549 circuit boards
DISTRIBUTION
Nationwide and Internationally
PRODUCT
SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO. Used to facilitate the delivery of defined radiotherapy treatment plans;
CODE
MOSAIQ versions 1.30 and 1.40 with Elekta iCom or Siemens
RECALLING FIRM/MANUFACTURER
Impac Medical Systems, Inc., Sunnyvale, CA,
REASON
Software issue may result in change to intended treatment field, Potentially resulting in mistreatment.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexible data acquisition and analysis package specifically designed for digital-based flow
cytometers;
CODE
Software versions 4.0.1 to 5.0.2.
RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA,
REASON
When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.
VOLUME OF PRODUCT IN COMMERCE
1,074 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe;
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Datex - Ohmeda, Inc., Madison, WI,
Manufacturer: Acutronic Medical Systems Ag, Hirzel, Switzerland.
REASON
Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engström Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.
VOLUME OF PRODUCT IN COMMERCE
394 (197 boxes and 2 Flow sensors/box)
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials
individually sold or packed as a component in the Difco(tm) "Shigella Grouping
Antiserum Set", Cat. 241108, Lot 6073806). Vials are labeled in part ***S. flexneri
Serotypes 1-6***Used for the identification of Shigella species by the slide
agglutination test;
b) Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722,
10 mL vials and labeled in part *** Used for the identification of Shigella species
by the slide agglutination test,
CODE
a) Lot 5059542 Exp March 30, 2008 Lot 6023471 Exp March 30, 2008
Lot 7072998 Exp March 30, 2008 Lot 7116967 Exp April 12, 2010;
b) Lot 6009070 Exp November 03, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD,
Manufacturer: BD Diagnostic Systems, Lee Laboratories, Grayson, GA.
REASON
In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
VOLUME OF PRODUCT IN COMMERCE
643 bottles
DISTRIBUTION
Nationwide and Internationally
PRODUCT
BCI ®3180 Oximeter - Patient monitoring medical device, For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments,
CODE
Serial Number AG06100001 AG06100063 AG06100069 AG06100097 AG06100098 AG06100099 AG06120001 AG06120002 AG06120003 AG06120004 AG06120008 AG06120009 AG06120012 AG06120013 AG06120018 AG06120020 AG06120022 AG06120026 AG06120030 AG06120031 AG06120034 AG06120035 AG06120036 AG06120038 AG06120039 AG06120040 AG06120041 AG06120042 AG06120043 AG06120044 AG06120045 AG06120046 AG06120047 AG06120049 AG06120050 AG06120051 AG06120054 AG06120055 AG06120056 AG06120057 AG06120058 AG06120059 AG06120060 AG06120061 AG06120063 AG06120066 AG06120067 AG06120068 AG06120069 AG06120070 AG06120071 AG06120073 AG06120074 AG05050047 AG05070028 AG05070030 AG05070031 AG05070033 AG05070036 AG05120044 AG05120051 AG06120052 AG06120062 AG07010000 AG07010001 AG07010002 AG07010003 AG07010004 AG07010005 AG07010006 AG07010007 AG07010008 AG07010009 AG07010010 AG07010011 AG07010012 AG07010013 AG07010014 AG07010015 AG07010016 AG07010017 AG07010018 AG07010019 AG07010020 AG07010021 AG07010023 AG07010024 AG07010026 AG07010027 AG07010028 AG07010031 AG07010032 AG07010033 AG07010034 AG07010035 AG07010036 AG07010037 AG07010038 AG07010039 AG07010040 AG07010042 AG07010043 AG07010045 AG07010046 AG07010047 AG07010048 AG07010049 AG07010050 AG07010051 AG07010052 AG07010053 AG07010054 AG07010055 AG07010056 AG07010058 AG07010059 AG07010067 AG07010070 AG07010074 AG07010080 AG07010085 AG05050000 AG05050001 AG05050002 AG05050003 AG05050004 AG05050006 AG05050007 AG05050010 AG05050012 AG05050013 AG05050014 AG05050015 AG05050016 AG05050017 AG05050018 AG05050020 AG05050021 AG05050022 AG05050023 AG05050024 AG05050025 AG05050027 AG05050028 AG05050030 AG05050031 AG05050032 AG05070019 AG05070021 AG05070024 AG05070025 AG05070026 AG05070027 AG05070029 AG06050054 AG06050055 AG06050056 AG06050057 AG06050058 AG06050060 AG06050062 AG06050063 AG06050064 AG06050067 AG06050068 AG06050069 AG06050070 AG06050072 AG06050073 AG06050074 AG06050075 AG06050076 AG06050077 AG06050079 AG06050080 AG06050081 AG06050082 AG06050083 AG06050084 AG06050085 AG06050086 AG06050087 AG06050088 AG06050089 AG06050091 AG06050092 AG06050094 AG06050099 AG06080001 AG06080002 AG06080003 AG06080004 AG06080005 AG06080006 AG06080007 AG06080008 AG06080009 AG06080010 AG06080011 AG06080012 AG06080014 AG06080015 AG06080016 AG06080017 AG06080018 AG06080019 AG06080020 AG06080021 AG06080022 AG06080025 AG06080026 AG06080028 AG06080031 AG06080032 AG06080033 AG06080037 AG06080056 AG06080057 AG06080060 AG06080061 AG06080062 AG06080063 AG06080064 AG06080066 AG06080067 AG06080069 AG06080070 AG06080071 AG06080072 AG06080075 AG06080076 AG06080079 AG05070099 AG05100010 AG05100013 AG05100018 AG05100020 AG05100023 AG05100024 AG05100025 AG05100028 AG05100031 AG05100038 AG06080029 AG06080036 AG06080038 AG06100009 AG06100054 AG05050026 AG05050029 AG05050033 AG05050034 AG05050037 AG05050040 AG05100007 AG05100008 AG05100053 AG05100056 AG05100072 AG05100073 AG06100071 AG06100073 AG06100074 AG06100075 AG06100076 AG06100077 AG06050004 AG06050053 AG06100030 AG05050063 AG05050065 AG05050066 AG05050067 AG05050071 AG05050072 AG05050074 AG05050076 AG05050077 AG05050080 AG05050081 AG05050083 AG05050087 AG05050088 AG05070014 AG05070049 AG05070050 AG05070051 AG05100026 AG05100048 AG07010076 AG07010110 AG07010112 AG07010117 AG07010124 AG07010126 AG07010128 AG07010129 AG07010073 AG07010094 AG07010099 AG07010107 AG07010119 AG05070059 AG05070060 AG05070061 AG05070066 AG05070067 AG05070068 AG05070070 AG05070072 AG05070073 AG05070075 AG05070076 AG05070077 AG06050042 AG06050059 AG06050065 AG06050071 AG06080023 AG06080030 AG06080034 AG06080040 AG06080042 AG06080043
Replacement Board AG05100006 AG05100097 AG07010030 AG06120064 AG07010022 AG07010025 AG07010029 AG07010044 AG07010057 AG06080051 AG06080052 AG06080055 AG06080058 AG06080059 AG06100018 AG06100019 AG06100020 AG06100021 AG06100022 AG06100028 AG06100061 AG06100066 AG06100068 AG06100070 AG06100095 AG06120000 AG06120005 AG06120006 AG06120007 AG06120010 AG06120011 AG06120014 AG06120015 AG06120016 AG06120017 AG06120019 AG06120021 AG06120023 AG06120024 AG06120025 AG06120027 AG06120028 AG06120029 AG06120032 AG06120033 AG06120037 AG06120048 AG07010060 AG07010061 AG07010062 AG07010063 AG07010064 AG07010077 AG07010083 AG07010133 AG05120092 AG06080097 AG06100000 AG07010072 AG05070052 AG05070053 AG05050019 AG05050038 AG05050039 AG05050041 AG05050042 AG05050055 AG05050056 AG05050058 AG05050060 AG05070008 AG06050005 AG06050006 AG06050007 AG06050011 AG06050012 AG06050013 AG06050014 AG06050015 AG06050017 AG06050019 AG06050020 AG06050022 AG06050025 AG06050026 AG06050028 AG06050030 AG06050033 AG06050035 AG07010084 AG07010086 AG07010087 AG07010088 AG07010090 AG07010091 AG07010092 AG07010093 AG07010095 AG07010096 AG07010097 AG07010101 AG07010113 AG07010114 AG07010115 AG07010116 AG05050090 AG05050092 AG05050095 AG05050097 AG05070016 AG05070020 AG05070022 AG05070023 AG05070032 AG05070035 AG06100002 AG06100003 AG06100004 AG06100017 AG06100023 AG06100024 AG06100026 AG06100027 AG06100029 AG06100032 AG06100034 AG06100036 AG06100040 AG06100041 AG06100042 AG06100044 AG06100045 AG06100046 AG06100047 AG06100048 AG06100049 AG06100052 AG06100057 AG06100064 AG06100065 AG07010065 AG07010068 AG07010075 AG07010079 AG07010082 AG07010103 AG07010104 AG07010105 AG07010106 AG07010118 AG05050044 AG05050049 AG05050057 AG05050061 AG05050062 AG06080024 AG06080045 AG06080046 AG06080047 AG06080048 AG06080050 AG06080053 AG06080054 AG06080068 AG06080077 AG06080078 AG06080080 AG06080081 AG06080082 AG06080083 AG06080084 AG06080085 AG06080086 AG06080087 AG06080088 AG06080089 AG06080090 AG06080091 AG06080092 AG06080093 AG06080094 AG06080095 AG06080096 AG06080098 AG06080099 AG05100014 AG05100027 AG05100054 AG05100057 AG05100058 AG05100059 AG05100060 AG05100061 AG05100062 AG05100063 AG05100064 AG05100066 AG05100068 AG05100069 AG05100070 AG05100071 AG05100079 AG05100080 AG05100081 AG05100082 AG05100087 AG05100089 AG05100090 AG05100092 AG05100093 AG05100094 AG05100095 AG05100098 AG05100099 AG05120002 AG05120005 AG05120006 AG05120008 AG05120009 AG05120010 AG05120011 AG05120012 AG05120013 AG05120014 AG05120015 AG05120016 AG06080013 AG05120023 AG06050002 AG05050045 AG05050046 AG05050048 AG05050050 AG05050052 AG05050053 AG05050054 AG05050059 AG06100060 AG06100078 AG06100079 AG06100080 AG06100081 AG06100082 AG06100083 AG06100084 AG06100085 AG06100086 AG06100087 AG06100088 AG06100089 AG06100090 AG06100091 AG06100092 AG06100093 AG06100094 AG06100096 AG07010066 AG07010102 AG07010121 AG07010122 AG07010125 AG07010127 AG07010130 AG07010132 AG07010134 AG07010135 AG07010136 AG07010137 AG07010138 AG07010139 AG07010140 AG07010141 AG07010142 AG07010143 AG07010147 AG07010149 AG07010150 AG07010151 AG07010153 AG06100031 AG06080000 AG06080039 AG06080044 AG06080065 AG06080073 AG06080074 AG06100008 AG06100010 AG06100011 AG06100012 AG06100013 AG06100014 AG06100015 AG06100016 AG06100033 AG06100035 AG06100037 AG06100038 AG06100039 AG06100043 AG05120022 AG05120038 AG05120042 AG05120043 AG05120048 AG05120049 AG05120056 AG05120064 AG05120066 AG05120069 AG05120073 AG05120082 AG05070054 AG05070055 AG05070056 AG05070058 AG05070081 AG05100022 AG05120040 AG05120041 AG05120045 AG05120059 AG05120060 AG05120063 AG05120065 AG05120067 AG05120070 AG05120071 AG05120072 AG05120074 AG05120075 AG05120076 AG05120077 AG05120078 AG05120079 AG05120080 AG05120083 AG05120084
Replacement Board AG05070045 AG05070046 AG05070047 AG05070048 AG06080049 AG06100005 AG06100006 AG06100007 AG07010148 AG05050068 AG05070043 AG05100021 AG06050040 AG06100053 AG06100059 AG05070044 AG05100011 AG07010100 AG05100083 AG05100086 AG05100088 AG05050070 AG05050085 AG05070002 AG05070003 AG05070004 AG05070005 AG05070006 AG05070007 AG05070009 AG05070011 AG06050078 AG06050090 AG06050093 AG06050095 AG05120058 AG06100051 AG05050043 AG05050073 AG05050075 AG05050078 AG05050079 AG05050082 AG05050084 AG05050086 AG05050089 AG05050091 AG05050093 AG05050094 AG05050098 AG05050099 AG05070000 AG05070001 AG05070010 AG05070012 AG05070013 AG05070015 AG05070017 AG05070018 AG05070057 AG05070062 AG05070063 AG05070064 AG05070065 AG05070069 AG05070071 AG05070074 AG05070078 AG05070079 AG05070080 AG05070083 AG05070084 AG05070085 AG05070086 AG05070087 AG05070088 AG05070089 AG05070091 AG05070092 AG05070093 AG05070094 AG05070096 AG06050021 AG06050023 AG06050024 AG06050027 AG06050031 AG06050032 AG06050034 AG06050041 AG06050043 AG06050044 AG06050045 AG06050046 AG06050047 AG06050048 AG06050049 AG06050050 AG06050051 AG06050052 AG06050061 AG06050066 AG07060047 AG05050005 AG05050011 AG05050035 AG05050064 AG05050069 AG06050037 AG07010108 AG07010111 AG05100032 AG07060049 AG05120031 AG05120095 AG06050036 AG06050096 AG06080027 AG06100025 AG06100062 AG06100067 AG05100096 AG05120037 AG05120087 AG05100033 AG05100039 AG05100045 AG05100046 AG05100047 AG05120032 AG05120034 AG06100058 AG06100072 AG05100030 AG05100041 AG05100043 AG05100044 AG05120085 AG05100035 AG05100040 AG05120030 AG06100055 AG05120088 AG05120090 AG06050001 AG06050003 AG06050008 AG06050009 AG06050010 AG05100009 AG05120026 AG05120035 AG05050036 AG05100034 AG05100036 AG05120021 AG05120039 AG05120093 AG06100050 AG05120091 AG06050016 AG06050018 AG05120052 AG05120054 AG05070082 AG05070090 AG05070095 AG05070097 AG05070098 AG05100037 AG05100042 AG05120096 AG06050000 AG05070037 AG05100049 AG05100065 AG05100084 AG05120007 AG05120025 AG05120028 AG05120029 AG05120036 AG05120081 AG05120086 AG05120089 AG07010041 AG07010078 AG07010109 AG05050051 AG05070038 AG05070039 AG05070040 AG05070041 AG05070042 AG05100091 AG05120027 AG05050009 AG05120068 AG05120098 AG05120099 AG05100016 AG07010069 AG07010071 AG07010081 AG07010098
Replacement Board AG06100056 AG06050029 AG05120033 AG05100015 AG05100017 AG05120046 AG05120050 AG05120053 AG05120055 AG06120053 AG06120065 AG06120072 AG07010089 AG07010123 AG07010131 AG07010152 AG07010154 AG05100012 AG05100029 AG05100050 AG05100051 AG05100052 AG05100055 AG05100067 AG05100074 AG05120057 AG05050096 AG05070034 AG05100005 AG05100085
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI,
REASON
The Smith Medical PM, Inc. BCI ®3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to indicate the event has occurred; or the monitor may exhibit erratic readings along with a "small pulse" or "lost pulse" alarm.
VOLUME OF PRODUCT IN COMMERCE
900 devices
DISTRIBUTION
Nationwide and Internationally
PRODUCT CADD-MS ®3 Ambulatory Infusion Pump, Model 7400 Smiths Medical International Ltd., WD24 4LG UK. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by homecare patients but can also used in health care facilities,
CODE
USA 440038 440096 440114 440122 440126 440128 440206 440235 440242 440247 440269 440313 440397 440418 440447 440455 440458 440484 440487 440501 440504 440560 440582 440584 440596 440614 440641 440848 440877 442365 442366 442367 442368 442369 442370 442371 442372 442373 442374 442375 442376 442377 442378 442364 442379 442380 442381 442382 442383 442384 442461 442462 442463 442464 442465 442466 442467 442468 442387 442388 442389 442390 442391 442392 442393 442394 442395 442396 442397 442398 442399 442400 442401 442402 442403 442404 442405 442406 442407 442408 442409 442410 442411 442412 442413 442414 442415 442416 442417 442418 442419 442420 442421 442422 442423 442424 442425 442426 442427 442428 442429 442430 442431 442432 442433 442434 442435 442436 442437 442438 442439 442440 442441 442442 442443 442444 442445 442446 442498 442448 441866 441867 441868 441869 441870 441871 441872 441873 441874 441875 441876 441877 441878 441879 441880 441881 441882 441883 441884 441885 441886 441887 441888 441889 441890 441891 441892 441893 441894 441895 441896 441897 441898 441899 441900 441901 441902 441903 441904 441905 441906 441907 441908 441909 441910 441911 441912 441913 441914 441915 441916 441917 441918 441919 441920 441921 441922 441923 441924 441925 441926 441927 441928 441929 441930 441931 441932 441933 441934 441935 441936 441937 441938 441939 441940 441941 441942 441943 441944 441945 441946 441947 441948 441949 441950 441951 441952 441953 441954 441955 441956 441957 441958 441959 441960 441961 441962 441963 441964 441965 441966 441967 441968 441969 441970 441971 441972 441973 441974 441975 441976 441977 441978 441979 441980 441981 441982 441983 441984 441985 441986 441987 441988 441989 441990 441991 441992 441993 441994 441995 441996 441997 441998 441999 442000 442001 442002 442003 442004 442005 442006 442007 442008 442009 442010 442011 442012 442013 442014 442015 442016 442017 442018 442019 442020 442021 442022 442023 442024 442025 442026 442027 442028 442029 442030 442031 442032 442033 442034 442035 442036 442037 442038 442039 442040 442041 442042 442043 442044 442045 442046 442047 442048 442049 442050 442051 442052 442053 442054 442055 442056 442057 442058 442059 442060 442061 442062 442063 442064 442065 442066 442067 442068 442069 442070 442071 442072 442073 442074 442075 442076 442077 442078 442079 442080 442081 442082 442083 442084 442085 442086 442087 442088 442089 442090 442091 442092 442093 442094 442095 442096 442097 442098 442099 442100 442101 442102 442103 442104 442105 442106 442107 442108 442109 442110 442111 442112 442113 442114 442115 442116 442117 442118 442119 442120 442121 442122 442123 442124 442125 442126 442127 442128 442129 442130 442131 442132 442133 442134 442135 442136 442137 442138 442139 442140 442141 442142 442143 442144 442145 442146 442147 442148 442149 442150 442151 442152 442153 442154 442155 442156 442157 442158 442159 442160 442161 442162 442163 442164 442165 442166 442167 442168 442169 442170 442171 442172 442173 442174 442175 442176 442177 442178 442179 442180 442181 442182 442183 442184 442185 442186 442187 442188 442189 442190 442191 442192 442193 442194 442195 442196 442197 442198 442199 442200 442201 442202 442203 442204 442205 442206 442207 442208 442209 442210 442211 442212 442213 442214 442215 442216 442217 442218 442219 442220 442221 442222 442223 442224 442225 442226 442227 442228 442229 442230 442231 442232 442233 442234 442235 442236 442237 442238 442239 442240 442241 442242 442243 442244 442245 442246 442247 442248 442249 442250 442251 442252 442253 442254 442255 442256 442257 442258 442259 442260 442261 442262 442263 442264 442265 442266 442267 442268 442270 442271 442272 442273 442274 442275 442276 442277 442278 442279 442280 442281 442282 442283 442284 442285 442286 442287 442288 442289 442290 442291 442292 442293 442294 442295 442296 442297 442298 442299 442300 442301 442302 442303 442304 442305 442306 442307 442308 442309 442310 442311 442312 442313 442314 442315 442316 442317 442318 442319 442320 442321 442322 442323 442324 442325 442326 442327 442328 442329 442330 442331 442332 442333 442334 442335 442336 442337 442338 442339 442340 442341 442342 442343 442344 442345 442346 442347 442348 442349 442350 442351 442352 442353 442354 442355 442356 442357 442358 442359 442360 442361 442362 442363 442385 441860 441861 441862 441863 441864 441865 442386 442447 OUSA 441857 441858 441859 442269 442492 442493 442494 442495 442496 442497 442482 442483 442484 442485 442486 442487 442488 442489 442490 and 442491
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN,
REASON
Smiths Medical discovered an issue with a motor component in specific serial numbers of the
CADD-MS ®3 Ambulatory Infusion Pump. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.
VOLUME OF PRODUCT IN COMMERCE
646 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Deltec Cozmo® Insulin Pump, Model 1700, This is a syringe infusion pump intended for Continuous Subcutaneous Insulin Infusion for the control of diabetes;
CODE
USA: A08931 A37582 A13919 A39717 A43779 A45238 A31455 A38022 A21231 A14506 A40945 A19565 A26902 A31456 A19183 A11164 A43688 A54693 A22987 A34082 A35045 A31734 A16731 A17680 A20964 A12734 A24282 A26705 A35021 A23011 A34093 A39305 A21668 A30450 A16812 A23847 A39749 A22562 A18159 A38668 A23865 A19831 A14238 A42892 A15124 A27546 A29491 A18301 A24937 A16705 A11642 A41116 A23918 A40202 A26898 A18536 A21528 A24912 A23885 A45265 A19655 A22949 A20090 A14889 A31446 A46481 A23843 A48103 A44743 A24915 A22512 A32363 A21651 A30518 A18807 A20095 A13355 A35483 A24920 A29444 A35971 A12348 A34381 A36301 A30298 A30294 A45962 A23118 A16306 A29579 A40122 A44079 A23057 A14766 A59064 A47805 A42830 A23713 A38977 A18625 A27345 A13259 A32088 A21117 A44520 A35605 A30301 A47556 A39474 A14930 A25210 A35185 A38857 A34922 A27575 A21109 A32117 A13116 A33028 A43376 A17517 A21397 A40084 A23249 A17541 A46130 A21168 A22859 A25431 A40360 A24036 A31866 A34386 A39033 A23372 A45821 A28832 A39169 A42688 A27708 A25557 A14218 A25441 A24062 A35773 A36049 A25957 A36902 A39166 A28844 A25588 A18307 A40670 A26240 A16055 A30771 A43865 A27355 A57681 A35005 A41347 A23612 A25584 A17427 A31296 A22226 A14179 A39931 A41047 A14168 A39952 A25586 A25401
Int. OUSA: A62390 - A62410, A64852 A64848 A64849 A64850 A64851 A13373 A43584 A31922 A43203 A20328 A22944 A23913 A25531 A27179 A34570 A39759 A10598 A14839 A24356 A37652 A43403 A23308 A31973 A13059 A15689 A20902 A46920 A29579 A40046 A40126 A42227 A17473 A33716 A23607 A27747 A64876 A64877 A64878 A64879 A64880 A64881 A64882 A64883 A64884 A64885 A64843 A64844 A64845 A64846 A64847 A64886 A64887 A64888 A64889 A64890 A64891 A64892 A64893 A64894 A64895 A64896 A64897 A64898 A64899 A64900 A64901 A64902 A64903 A64904 A64905 A64853 A64854 A64855 A64856 A64857 A64858 A64859 A64860 A64861 A64862 A64863 A64864 A64865 A64866 A64867 A64868 A64869 A64870 A64871 A64872 A64873 A64874 A64875 A23694 A62389 A62411 A62412 A62413 A62414 A62415 A62416 A62417 A62418 A62419 A62420 A62421 A62422 A62423 A62424 A62425 A62426 A62427 A62428 A62429 A62430 A62431 A62432 A62433 A62434 A62435 A62436 A62437 A62438 A62439 A62440 A62441 A62442 A64283 A64284 A64285 A64286 A64287 A37787 A64314 A64315 A64316 A64317 A64318 A64319 A64320 A64321 A64322 A64323 A64294 A64295 A64296 A64297 A64298 A64299 A64300 A64301 A64302 A64303 A64304 A64305 A64306 A64307 A64308 A64309 A64310 A64311 A64312 A64313 A64288 A64289 A64290 A64291 A64292 A64293 A28988 A44353 A29785 A42587 A27355 A22226 OUSA GERMANY A15333 A22296 A26590 A39620 A36148 A12916 A15802 A37829 A15783 A31614 A26588 A52036 A25358 A56553 A43596 A35741 A26279 A56671 A39281 A56678 A26437 A26508 A20796 A54523 A11423 A21748 A26404 A40423 A31601 A53074 A54437 A11768 A26460 A24169 A28369 A17974 A23650 A24394 A22742 A20848 A40466 A39649 A46748 AUSTRALIA A58721 A36572 A16409 A47779 A34280 A48715 A48800 A35900 A36880 A27391 A22826 A41379 A39273 A40077 A44953 A19952 A44360 A27706 A26090 A43476 A48470 A46076 A34462 A57692
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN,
REASON
Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo ®Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.
VOLUME OF PRODUCT IN COMMERCE
1,502 units
DISTRIBUTION
Nationwide
PRODUCT
Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791;
CODE
Lot Numbers: W0801021, W801104, W0711154
RECALLING FIRM/MANUFACTURER
Integra Pain Management, Salt Lake City, UT,
REASON Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.
VOLUME OF PRODUCT IN COMMERCE
500 kits
DISTRIBUTION
CO
PRODUCT
1) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case;
2) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case;
3) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9020, Size (Fr) 20, # Eyelets 4, 10 per case;
4) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9024, Size (Fr) 24, # Eyelets 5, 10 per case;
5) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9028, Size (Fr) 28, # Eyelets 6, 10 per case;
6) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9032, Size (Fr) 32, # Eyelets 6, 10 per case;
7) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9036, Size (Fr) 36, # Eyelets 6, 10 per case;
8) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case;
9) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9116, Size (Fr) 16, # Eyelets 4, 10 per case;
10) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9120, Size (Fr) 20, # Eyelets 4, 10 per case;
11) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9124, Size (Fr) 24, # Eyelets 4, 10 per case;
12) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with
Tapered Connector Tip, Atrium Code # 9128, Size (Fr) 28, # Eyelets 5,
10 per case;
13) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with
Tapered Connector Tip, Atrium Code # 9132, Size (Fr) 32, # Eyelets 5,
10 per case;
14) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with
Tapered Connector Tip, Atrium Code # 9136, Size (Fr) 36, # Eyelets 5,
10 per case;
15) ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408,
Size (Fr) 8, # Eyelets 2, 10 per case;
16) ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420,
Size (Fr) 20, # Eyelets 2, 10 per case;
17) ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9428,
Size (Fr) 28, # Eyelets 2, 10 per case;
18) HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium
Code # 14120, Size (Fr) 20, # Eyelets 5, 10 per case;
19) HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium
Code # 14124, Size (Fr) 24, # Eyelets 6, 10 per case;
20) HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium
Code # 14132, Size (Fr) 32, # Eyelets 6;
21) HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal,
Eyes on Top & Bottom, Atrium Code # 14509, Size 9mm, # Eyelets 9,
10 per case;
22) HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal,
Eyes on Top, Atrium Code # 14709, Size 9mm, # Eyelets 6, 10 per case;
23) HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased
number of eyelets, Increased Length by 6", Atrium Code # 14720, Size 20,
# Eyelets 15, 10 per case;
24) HydraGlide XL Heparin Coated Silicone Thoracic Catheters, with
oversulfated chondroitin sulfate;
CODE
1) Lot # 10311107;
2) Lot #s 10304311, 10321933, 10336423;
3) Lot #s 10321934,10336528,10337106;
4) Lot #s 10311122, 10321935,10342004, 10348451;
5) Lot #s 10289970, 10311123, 10311257, 10327131;
6) Lot #s 10300922, 10307009, 10311228, 10318705, 10321932,
10336320, 10336530;
7) Lot #s 10311124, 10318749, 10336424, 10348452;
8) Lot #s 10341904, 10348104;
9) Lot # 10311108;
10) Lot #s 10300921, 10326510, 10358305;
11) Lot #s 10321936, 10348204;
12) Lot #s 10300923, 10311229, 10318744, 10336321, 10348453;
13) Lot #s 10289971, 10311230, 10318745, 10334208, 10336425, 10348454;
14) Lot #s 10304312, 10318704, 10336531;
15) Lot # 10311106;
16) Lot # 10307010;
17) Lot # 10358504;
18) Lot # 10327128;
19) Lot #s 10304308, 10311258, 10327153;
20) Lot #s 10304309, 10318735, 10344304;
21) Lot 10311260;
22) Lot # 10327130;
23) Lot #s 10307011, 10311261, 10318740, 10327154, 10336322, 10336532;
24) Lot #s 10304307, 10307012, 10311125, 10311233, 10318739, 10327129,
10336323, 10336426
RECALLING FIRM/MANUFACTURER
Atrium Medical Corporation, Hudson, NH,
REASON
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate.
VOLUME OF PRODUCT IN COMMERCE
1,842 cases (10 Individual/case)
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200µl,
Heparinized: 6 IU Na & 9 IU Li/100 µl, Part #MC0024;
CODE
Lot #1112254
RECALLING FIRM/MANUFACTURER
Recalling Firm: Opti Medical Systems Inc, Roswell, GA,
Manufacturer: Vitrex Medical ApS, Herlev, Denmark.
REASON
This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.
VOLUME OF PRODUCT IN COMMERCE
31,750 tubes
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2,
Part Number: 1001934-06, Designed to provide a pathway trough
which therapeutic and diagnostic devices are introduced;
b) 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L,
Part Number: 1001970-06, Intended to provide a pathway through
which therapeutic and diagnostic devices are introduced;
CODE
a) and b) : Lot # 8011791
RECALLING FIRM/MANUFACTURER
Abbott Vascular-Cardiac Therapies dba Guidant Corporation, Temecula, CA,
REASON
The part number on the product label packaging may not match the product.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide
WEEK ENDING AUGUST 30
PRODUCT Access
Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and
Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i
System. Instrument part numbers 81600 and 81600N;
CODE
Part numbers only
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: Beckman Coulter, Inc., Chaska, MN.
REASON
Electrical
grounding failure: During manufacturing, internal testing found one instrument
with an intermittent failure of the electrical grounding. The source of the
problem was traced to inadequate soldering.
VOLUME OF PRODUCT IN
COMMERCE 3,247 Instruments
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Biomet brand Modular Microplasty Cup Inserter, 3/8" thread; Model 31-400600 assembled with a 3/8" threaded insert; Model 31-400603. Instrument for hip
prosthesis acetabular cup component;
b) Biomet
brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model
31-400603. Instrument for hip prosthesis acetabular cup component;
c) Biomet Microplasty Cup
Impactor, 1/4" -28 Thread Insert;
Model 31-400605. Instrument for hip prosthesis acetabular cup component;
CODE
a) Lots: 095116, 095117,
096758, 0967822 and 096824;
b) Lot 095207;
c) Lots: 095209, 095210,
096830, 096857 and 096858
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN,
Manufacturer: C & A Tool Engineering Inc., Churubusco, IN.
REASON
The weld at the lock
location may fracture during impaction.
VOLUME OF PRODUCT IN
COMMERCE 458
Instruments
DISTRIBUTION Nationwide and
Internationally
PRODUCT Bio-Rad
MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic;
CODE
Lot Number 232BGG
RECALLING
FIRM/MANUFACTURER Bio-Rad Laboratories, Redmond, WA,
REASON
Incorrect result: Elevated reactivity
with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.
VOLUME OF PRODUCT IN
COMMERCE 31
units
DISTRIBUTION Nationwide
PRODUCT
a)
Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-197,
b) Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy Cardioverter/Defibrillator, Model V-235;
c)
Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model
V-337;
d) Implantable Cardioverter Defibrillator EPIC HF
Tiered-therapy Cardioverter/Defibrillator with Biventricular Stimulation,
Model V-338;
e) Implantable Cardioverter
Defibrillator EPIC HF Tiered-therapy Cardioverter/defibrillator with
biventricular stimulation, Model V-339;
f)
Implantable Cardioverter Defibrillator EPIC + VR Tiered-therapy Cardioverter/defibrillator, Model V-196;
g)
Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy Cardioverter/defibrillator, Model V-233;
h)
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy Cardioverter/defibrillator, Model V-236;
i)
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy Cardioverter/defibrillator, Model V-239;
j)
Implantable Cardioverter Defibrillator EPIC + HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model
V-350;
k) Implantable Cardioverter Defibrillator EPIC II VR
Tiered-therapy Cardioverter/defibrillator, Model V-158;
l) Implantable Cardioverter Defibrillator EPIC II DR
Tiered-therapy Cardioverter/defibrillator, Model V-255;
m) Implantable Cardioverter Defibrillator EPIC II+ DR
Tiered-therapy Cardioverter/defibrillator, Model V-258;
n) Implantable Cardioverter Defibrillator EPIC II HF
Tiered-therapy Cardioverter/defibrillator with Biventricular Stimulation,
Model V-355;
o) Implantable Cardioverter
Defibrillator EPIC II+ HF Tiered-therapy Cardioverter/defibrillator with
Biventricular Stimlation, Model V-357;
p)
Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy Cardioverter/defibrillator with Biventricular Stimulation, Model V-356;
q) Implantable Cardioverter Defibrillator ATLAS +
VR Tiered-therapy Cardioverter/defibrillator, Model V-193;
r) Implantable Cardioverter Defibrillator ATLAS DR
Tiered-therapy Cardioverter/defibrillator, Model V-242;
s) Implantable Cardioverter Defibrillator ATLAS + DR
Tiered-therapy Cardioverter/defibrillator, Model V-243;
t) Implantable Cardioverter Defibrillator ATLAS + HF
Tiered-therapy Cardioverter/defibrillator with biventricular stimulation,
Model V-341;
u) Implantable Cardioverter
Defibrillator ATLAS + HF Tiered-therapy Cardioverter/defibrillator with
biventricular stimulation, Model V-340;
v)
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model
V-343;
w) Implantable Cardioverter Defibrillator
ATLAS II VR Tiered-therapy Cardioverter/defibrillator, Model V-168;
x) Implantable Cardioverter Defibrillator ATLAS II DR
Tiered-therapy Cardioverter/defibrillator, Model V-265;
y) Implantable Cardioverter Defibrillator ATLAS II+ DR
Tiered-therapy Cardioverter/defibrillator, Model V-268;
z) Implantable Cardioverter Defibrillator ATLAS II HF
Tiered-therapy Cardioverter/defibrillator with biventricular stimulation,
Model V-365;
aa) Implantable Cardioverter
Defibrillator ATLAS II+ HF Tiered-therapy Cardioverter/defibrillator with
biventricular stimulation, Model V-366;
bb)
Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-367;
CODE All serial
numbers
RECALLING FIRM/MANUFACTURER St Jude Medical CRMD,
Sylmar, CA,
REASON A condition that
could lead to a ventricular sensing anomaly in Epic and Atlas family of
implantable Cardioverter Defibrillators (ICDs) has been identified. A loss of
ventricular sensing would prevent the ICD from being able to detect an
arrhythmia. If an arrhythmia occurred and the device was unable to detect it,
then a patient would not receive potentially life saving
therapy.
VOLUME OF PRODUCT IN COMMERCE Over 143,000
defibrillators
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on
user-specified sequences and volumes. Models 2400-D, 2400-M, 2400-L;
b) Exacta-Mix 600 Pharmacy Compounding System is used in the
pharmacy to compound multiple source ingredients into on final solution
based on user-specified sequences and volumes. Model 071B-RS232;
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER Baxa Corporation, Englewood, CO,
REASON
Flush solution from TPN compounder may be
added to patient's TPN bag.
VOLUME OF PRODUCT IN
COMMERCE 1,221
systems
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery. Catalog number: 486619190;
b)
Radius Capsin is a non-sterile instrument for use with other devices in spinal surgery. Catalog number: 486619210;
CODE
a) Lot numbers: 067805, 067806, 067807,
06D694;
b) Lot numbers: 06A277, 06A279, 06D632
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ,
Manufacturer: Stryker Spine,
Cestas, Aquitane,
France. REASON
a) The
t-bar of the Radius Rod Persuader devices froze due to a loosening screw causing the device to fail;
b) The Radius Capsin has separation of the
tip from the inserter.
VOLUME OF PRODUCT IN COMMERCE
a)
65 Persuaders; b) 52
Capsins
DISTRIBUTION Nationwide
PRODUCT
Given®
Diagnostic System with PillCam® SB Capsule - Gastrointestinal capsule imaging
system. The device is an ingestible telemetric gastrointestinal capsule imaging
system is used for visualization of the small bowel mucosa as an adjunctive tool
in the detection of abnormalities of the small bowel. The device captures images
of the small bowel with a wireless camera contained in a capsule. This device
includes an ingestible capsule (containing a light source, camera, transmitter,
and battery), an antenna array, a receiving/recording unit, a data storage
device, computer software to process the images, and accessories;
CODE
GMB-0253-01-GLR Card-Proposed
Diagnostic Algorithm for Suspected Crohn's Disease.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Given Imaging Inc., Duluth, GA,
Manufacturer: Given Imaging Ltd.,
Yokneam,
Israel.
REASON The
cards included in the product's education kit (proposing a clinical algorithm
for capsule endoscopy in patients with suspected Crohn's disease), were printed
incorrectly.
VOLUME OF PRODUCT IN COMMERCE 1,392
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Allen
Medical C-Flex, Polar Head Positioner. Catalog Number: A-70700-A1. Product is a
medical device used to maintain the position of an anesthetized patient during
surgery;
CODE Serial Numbers:
A111211, A116292
RECALLING FIRM/MANUFACTURER Allen
Medical Systems, Inc., Acton, MA
REASON Handle jamming in the open position,
preventing the device from adequately supporting the head during spinal surgery.
Possible delay in surgery, or injury.
VOLUME OF PRODUCT IN
COMMERCE 2 devices
DISTRIBUTION MA,
MS
PRODUCT
a)
VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872;
b) VITALITY EL, models T127, T167, T177 Implantable
Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber;
CODE
Devices that are implanted subpectorally
with the serial number facing the ribs.
RECALLING
FIRM/MANUFACTURER Boston Scientific CRM Corporation, Saint Paul, MN
REASON
Repetitive mechanical stress applied to
the titanium case can induce component damage and device malfunction in certain
ICD and CRT-D devices implanted subpectorally with the serial number facing the
ribs. Devices implanted subcutaneously or in a subpectoral position with the
serial number facing away from the ribs are not included in this advisory. This
update identifies additional VITALITY ICD models that are also subject to this
failure mechanism if implanted in a susceptible orientation. Consequence
includes: Loss of shock therapy, loss of pacing therapy (intermittent or
permanent), or loss of telemetry communications.
VOLUME OF PRODUCT IN
COMMERCE 25,000
DISTRIBUTION Nationwide and
Internationally
PRODUCT
3DKNEE
Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; Used in surgery to
determine the correct size of 3DKnee component to implant that would allow for
the best range of motion and joint stability;
CODE Lot #53906407
RECALLING
FIRM/MANUFACTURER Encore Medical, Lp, Austin, TX
REASON
Tibial insert trial incorrectly marked
for thickness; device thickness marked correctly as 13mm on the underside of the
trial, but is incorrectly marked as 15mm on the side.
VOLUME OF
PRODUCT IN COMMERCE 6
units
DISTRIBUTION Germany
PRODUCT
The
OptiVantage DH Injection System is a contrast delivery system and is designed to
inject radiopaque contrast media into a patient's vascular system to obtain
diagnostic images when used with computed tomography equipment. The J-Bow
component is used to connect the powerhead to a suspension system. Catalog
#V8400, Part No. 241078 & Catalog #V8402, Part #241079;
CODE
Part numbers only
RECALLING
FIRM/MANUFACTURER Mallinckrodt, Inc., Cincinnati, OH
REASON
Screws can begin to loosen and shear off
to the point of the J-Bow falling from the suspension system. This may cause
injury to patients or hospital staff.
VOLUME OF PRODUCT IN
COMMERCE 783 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
Excimer
Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the
VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic
instrument intended for the automated measurement; analysis and recording of
refractive errors and wavefront aberrations to the target shape and then
generates the commands for the VISX STAR laser to create the target shape on the
cones. Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478;
CODE
All systems with software
version 3.65 and earlier
RECALLING FIRM/MANUFACTURER Visx
Incorporated, a subsidiary of AMO, Inc., Santa Clara, CA,
REASON
Firm
became aware of a significant overcorrection in one eye of a patient who had
received a wavefront-guided LASIK treatment at a facility in Germany. The
probability of a recurrence of this error was determine to be extremely remote,
however to prevent re-occurrence of this type of incident a software update was
developed.
VOLUME OF PRODUCT IN COMMERCE 1,310
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Omnifit
EON Surgical Protocol;
CODE Literatur Number LSP48
4/04
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Corporation, Mahwah,
NJ
REASON The Table 2 Broach and Neck
Trial Sizing (Literature # LSP48 04/04) on page 3 is incorrect, reading 5mm less
than what it should be for certain sizes.
VOLUME OF PRODUCT IN
COMMERCE 2,501 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
HerpeSelect
1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the
presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human
sera;
CODE Lot Codes 063169 (Expires
December 2007), 063354 (Expires October 2007), 063355 (Expires July
2007)
RECALLING FIRM/MANUFACTURER Focus Diagnostics,
Inc., Cypress, CA
REASON A small percentage of samples tested in
specific lots, the HSV common antigen band appears lighter (less reactive) than
the reading control band. Reduced reactivity of the common antigen band may lead
to inaccurate interpretation of a sample as negative.
VOLUME OF
PRODUCT IN COMMERCE 187
kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Medical
charged-particle radiation therapy system. Siemens Linear Medical Accelerators
equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH
030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857,
and 8141835 and applies only to those parts used with the following devices:
Coherence AG Therapist; Coherence Therapist System; Coherence Impression
Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0
and PRIMEVIEW 3i 2.0;
CODE Software
Numbers 7358299, 7360857, and 8141835
RECALLING
FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord, CA,.
REASON
A image issue: a complaint that images
viewed in the device may shift, which could result in mistreatment.
VOLUME OF PRODUCT IN COMMERCE 359
systems
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away
Detachable Footrests, Fixed Height. item #MDS809650 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating
Legrests, Fixed Height;
b) Bariatric Wheelchair, 26" Wide and 20" Deep
Seat, 700 lb. Weight Capacity; Item #MDS809700 comes with Removable
Full-Length Arms, Swing-Away Detachable Footrests, Hemi-Height Adjustable.
item #MDS809750 comes with
Removable Full-Length Arms, Swing-Away Detachable
Elevating Legrests, Hemi-Height Adjustable;
c)
Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Item #MDS809800 comes with Removable Desk-Length Arms, Swing-Away Detachable
Footrests, Hemi-Height Adjustable. item #MDS809850 comes with Removable
Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height
Adjustable;
CODE All wheelchairs
purchased between 12/01/2005 and 08/31/2007
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medline Industries Inc.,
Mundelein, IL
Manufacturer: Taiwan An I Co., Ltd., Shi-koou Shiang, Chia-yi
Hsien,
Taiwan.
REASON Fingers
can get injured. There is a potential for users to pinch their fingers between
the seat bars when opening the wheelchairs. Injuries can be severe from
fractures to severing.
VOLUME OF PRODUCT IN
COMMERCE 1,138
wheelchairs
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Infusion
System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug
Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only.
Connector clip is CIC Connector Clip; Part Number: 700-4000. The infusion system
is intended for the controlled and selective infusion of physician-specified
fluids, including thrombolytes, into the peripheral vasculature;
CODE
CIC Connector Clip; Lot numbers:
080324024, 080324025, 080324026, 080324027, 080325002, 080325003;
EndoWave
System Control Unit S/N: PT3B-001, PT3B-002, PT3B-004, PT3B-006, PT3B-007,
PT3B-008, PT3B-009, PT3B-010, PT3B-011, PT3B-012, PT3B-013, PT3B-014, PT3B-017,
PT3B-018, PT3B-020, PT3B-021, PT3B-022, PT3B-024, PT3B-025, PT3B-027, PT3B-029,
PT3B-030, PT3B-031, PT3B-032, PT3B-033, PT3B-034, PT3B-035, PT3B-037, PT3B-038,
PT3B-040, PT3B-041, PT3B-042, PT3B-043, PT3B-044, PT3B-045, PT3B-046, PT3B-047,
PT3B-049, PT3B-050, PT3B-051, PT3B-052, PT3B-057, PT3B-058, PT3B-059, PT3B-060,
PT3B-062, PT3B-063, PT3B-064, PT3B-065, PT3B-066, PT3B-067, PT3B-068, PT3B-070,
PT3B-071, PT3B-072, PT3B-073, PT3B-074, PT3B-075, PT3B-076, PT3B-078, PT3B-079,
PT3B-080, PT3B-082, PT3B-084, PT3B-085, PT3B-087, PT3B-088, PT3B-089, PT3B-090,
PT3B-091, PT3B-093, PT3B-094, PT3B-095, PT3B-096, PT3B-097, PT3B-098, PT3B-099,
PT3B-100, PT3B-102, PT3B-103, PT3B-104, PT3B-108, PT3B-109, PT3B-110, PT3B-111,
PT3B-112, PT3B-113, PT3B-114, PT3B-115, PT3B-118, PT3B-119, PT3B-121, PT3B-123,
PT3B-124, PT3B-127, PT3B-128, PT3B-130, PT3B-131, PT3B-132, PT3B-133, PT3B-135,
PT3B-137, PT3B-138, PT3B-139, PT3B-140, PT3B-141, PT3B-143, PT3B-145, PT3B-146,
PT3B-147, PT3B-148, PT3B-150, PT3B-151, PT3B-152, PT3B-153, PT3B-154, PT3B-155,
PT3B-156, PT3B-157, PT3B-158, PT3B-159, PT3B-163, PT3B-164, PT3B-165, PT3B-168,
PT3B-169, PT3B-172, PT3B-173, PT3B-174, PT3B-175, PT3B-176, PT3B-177, PT3B-178,
PT3B-180, PT3B-181, PT3B-183, PT3B-186, PT3B-188, PT3B-192, PT3B-193, PT3B-195,
PT3B-196, PT3B-197, PT3B-199, PT3B-201, PT3B-202, PT3B-204, PT3B-205, PT3B-206,
PT3B-207, PT3B-208, PT3B-210, PT3B-211, PT3B-212, PT3B-214, PT3B-215, PT3B-217,
PT3B-218, PT3B-219, PT3B-221, PT3B-253, PT3B-254, PT3B-255, PT3B-256, PT3B-257,
PT3B-258, PT3B-259, PT3B-260, PT3B-261, PT3B-262, PT3B-263, PT3B-264, PT3B-265,
PT3B-266, PT3B-267, PT3B-268, PT3B-269, PT3B-270, PT3B-271, PT3B-273, PT3B-274,
PT3B-275, PT3B-276, PT3B-280, PT3B-285, PT3B-286, PT3B-287, PT3B-288, PT3B-289,
PT3B-291, PT3B-292, PT3B-294, PT3B-295, PT3B-297, PT3B-298, PT3B-308, PT3B-310,
PT3B-311, PT3B-312, PT3B-313, PT3B-314, PT3B-315, PT3B-316, PT3B-319, PT3B-320,
PT3B-321, PT3B-323, PT3B-326, PT3B-328, PT3B-329, PT3B-332, PT3B-333, PT3B-334,
PT3B-335, PT3B-337, PT3B-338, PT3B-339, and PT3B-344
RECALLING
FIRM/MANUFACTURER EKOS Corporation, Bothell, WA,
REASON
Catheter disconnection. There is a
potential for the catheter to disconnect from the Catheter Interface Cable (CIC)
pod which connects to the Control Unit.
VOLUME OF PRODUCT IN
COMMERCE 218
units
DISTRIBUTION Nationwide
PRODUCT
CELL-DYN
Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface
Specification. For in vitro diagnostic use in counting and characterizing blood
cells;
CODE Revision
B
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa
Clara, CA
REASON Table in LIS Specification depicting the
association between Record ID and Numerical Result Label is incorrect. If a
record ID is used to configure the system for mapping, results will come out
nonsensical.
VOLUME OF PRODUCT IN COMMERCE 15 spec
sheets
DISTRIBUTION Nationwide
PRODUCT
Osteo-Clage
Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850
mm CoCr Cable / Sleeve... REF 01-0001-S;
CODE Lot: W59192 (W=work order,
###=sequential number); Expiration date: 2015-01
(Year/Month)
RECALLING FIRM/MANUFACTURER Acumed LLC,
Hillsboro, OR,
REASON Cables of incorrect diameter were used in
product assembly, resulting in the sleeve not being able to bind to the cable
after crimping.
VOLUME OF PRODUCT IN COMMERCE 50
units
DISTRIBUTION Nationwide
PRODUCT
StatSampler
200 uL, Li Heparin (micro blood collector); Ref: SS2H. Packed in Catalog
Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit). Intended
for collection and processing of capillary blood to prepare plasma/serum;
CODE
Lot number: 7296 Expiration Date:
12/09; Lot 8031 Expiration Date: 3/10
RECALLING
FIRM/MANUFACTURER
Recalling Firm: StatSpin, Inc., dba Iris Sample
Processing, Westwood MA,
Manufacturer: Drummond Scientific Co., Broomall PA.
REASON
EDTA inadvertently mixed with lithium
heparin solution contained in capillary tubes.
VOLUME OF PRODUCT IN
COMMERCE 171 vials
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) Equal
Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number
80-2005-01, Reagent lot Number 491686;
b) Equal
Diagnostics Lipase Color Reagent Kit Part Number: 905-C For In Vitro Use Containing the Lipase Color Reagent, 30 ml, Part Number
2005-01, Reagent lot Number 491686;
c) Equal
Diagnostics Lipase Color Reagent Kit Part Number: 905-D For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number
2005-01,
Reagent lot Number 491686;
d) Equal
Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number
2005-01,
Reagent lot Number 491686;
CODE
a) Lot # 7EPM30 exp 01/15/09;
b) Lot
# 7EPN32 Exp 01/15/09;
c) Lot # 7EP027 exp 01/15/09;
d) Lot # 7EPP31 exp
01/15/09
RECALLING FIRM/MANUFACTURER Genzyme Corporation,
Cambridge, MA,
REASON Calibration and Quality Control outside
of established range resulting from an increase in initial OD readings with the
reagent contained within the kits.
VOLUME OF PRODUCT IN
COMMERCE 3,443
units
DISTRIBUTION Nationwide
Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs)
PRODUCT:
LifePak CR Plus Automated External Defibrillator
Product Number:
3200731-003 and 3200731-027. This device was manufactured from May 20, 2004 through August 11, 2007
and distributed from May 20, 2004 through December 4, 2007.
USE: These devices are used by emergency or medical personnel, or by others who have taken the appropriate training to use this AED. The devices are intended to treat adults in cardiopulmonary arrest (heart attack). They analyze an unconscious patient’s heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.
RECALLING FIRM:: Physio Control, Inc.
REASON: The AED instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder is not able to provide therapy (shock).
CONTACT: Customers with questions may call Physio Control, Inc. at 1-425-867-4000, extension 4644.