MARCH 2008
WEEK ENDING MARCH 1
PRODUCT Intuitive
Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5
software level, Surgical Endoscopic Instrument Control System, Model Number: IS
2000, Software Revision Numbers: A5.0 P5 and A5.1 P1,
CODE
System Numbers: all starting with
"SG"--
043, 156, 088, 128, 065, 104, 106, 132, 019, 051, 058, 083, 092, 096, 165, 170,
098, 105, 157, 050, 112, 125, 138, 149, 034, 061, 121, 030, 044, 052, 054, 068,
069, 123, 147, 151, 013, 113, 152, 014, 049, 077, 134, 136, 066, 085, 091, 129,
087, 139, 140, 042, 047, 031, 089, 017, 021, 022, 115, 116, 137, 155, 168, 169,
041, 095, 119, 163, 164, 114, 057, 060, 101, 117, 122, 029, 020, 028, 056, 093,
094, 141, 103, 072, 084, 011, 024, 036, 053, 059, 144, 145, 146, 026, 074, 154,
018, 027, 055, 070, 109, 110, 111, 118, 120, 135, 099, 232, 033, 082, 148, 012,
015, 039, 067, 102, 124, 161, 166, 037, 097, 040, 064, 090, 127, 133, 025, 062,
143, 160, 038, 153, 035, 071, 073, 107, 158, 167, 086, 131, 063, 080, 078, 159,
076, 045, 081, 108, 150, 046, 075, 130, 004, 005, 006, 007, 010, 048, and
126
RECALLING
FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA,
REASON
System Lock-Up: Software anomalies could
cause product failure during use, or on start-up. System transitions to a safe
"soft-lock" state.
VOLUME OF PRODUCT IN COMMERCE 154
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Intuitive brand da Vinci S Surgical System, Endoscopic
Instrument Control System,
Model IS1200 with Isolation
Transformer (P/N: 952012) and Vision Cart (Model
VS1000),
b) Intuitive brand da Vinci S Surgical System,
Endoscopic Instrument Control System,
Model IS2000 with
Isolation Transformer (P/N: 952012) and Vision Cart (Model:
VS2000),
CODE
a) Lots: SG015, SG053, SG060, SG067,
SG096, SG126, SG151, SG164, SG201,
SG245, SG267, SG269,
SG270, SG271, SG272, SG273, SG275, SG276, SG278,
SG280, SG282, SG283, SG285, SG286, SG287, SG288, SG289, SG290,
SG291,
SG292, SG293, SG294, SG295, SG296, SG297, SG298,
SG299, SG300, SG301,
SG302, SG303, SG309, SG312, SG313,
SG314, SG315, SG316, SG317, SG318,
SG319, SG323, SG324,
SG325, SG326, SG329, and SG330;
b) Lots: SG015, SG053, SG060, SG067, SG096,
SG126, SG151, SG164, SG201,
SG245, SG267, SG269, SG270,
SG271, SG272, SG273, SG275, SG276, SG278,
SG280, SG282,
SG283, SG285, SG286, SG287, SG288, SG289, SG290, SG291,
SG292, SG293, SG294, SG295, SG296, SG297, SG298, SG299, SG300, SG301,
SG302, SG303, SG309, SG312, SG313, SG314, SG315, SG316,
SG317, SG318,
SG319, SG323, SG324, SG325, SG326, SG329,
and SG330
RECALLING FIRM/MANUFACTURER Intuitive Surgical,
Inc., Sunnyvale, CA,
REASON Under-Rated
Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System
Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a
5A fuse for 230V operation. Operation of this product with the use of an
under-rated fuse will result in failure of the fuse and a loss of power to the
vision cart, including the loss of power to any ancillary equipment that may be
connected to the vision cart isolation transformer.
VOLUME OF PRODUCT
IN COMMERCE 63 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) Hill-Rom Affinity Birthing Bed, Model P3600,
b) Hill-Rom Affinity Birthing Bed, Model P3600,
c) Hill-Rom Affinity Birthing Bed, Model P3700A,
d) Hill-Rom Affinity Birthing Bed, Model P3700B. Note: Not
distributed in the U.S.,
CODE All units (**Affinity beds manufactured
with serial number 1290AA7395 or greater are not impacted by this
correction.)
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc.,
Batesville, IN
REASON Hole/opening on the labor bar --
Amputation of a finger could result, if a finger is placed into the opening, as
the hole/opening creates a shear point when the mechanism is
activated.
VOLUME OF PRODUCT IN COMMERCE 32,379
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N
9600,
b) Nova - EZ CHEM Control
Solution P/N 9612,
c) Nova - EZ CHEM Linearity Solution
P/N 9618,
CODE
a) Serial Numbers:
39000207226 39000207229 39000207256 39000207270
39000307226 39000307229 39000307256 39000307270 39000407229
39000407270 39000507226 39000507229 39000507270
39000607229
39000607270 39000707229 39000707270
39000807226 39000807229
39000907270 39001007229
39001007256 39001007270 39001107229
39001107256
39001107270 39001207256 39001207270 39001307256
39001307270 39001407256 39001407270 39001507256 39001507270
39001607256 39001607270 39001707256 39001707270
39001807256
39001807270 39001907256 39001907270
39002007256 39002007270
39002107256 39002107270
39002207256 39002207270 39002307256
39002307270
39002407256 39002407270 39002507256 39002507270
39002607256 39002707256 39002907256 39003007256 39003107256
39003207256 39003307256 39006207249 39006307249
39006407249
39006507249 39006607249 39006607263
39006707249 39006707263
39006807249 39006807263
39006907249 39006907263 39007007263
39007107263
39007207263 39007307249 39007407249 39007507249
39007807249 39007907249 39008007249 39008107249 39008207249
39008307249 39008407249 39008507249 39008607249
39009607263
39009707263 39009807263 39009907263
39010007263 39010507275
39010607275 39010707275
39010807275 39010907275 39011007275
39011107275
39011207275 39011507275 39011607275 39011707275
39011807275 39011907275 39012007275 39012107275 39012307275
39012807275 39012907275 39013007275 39013207275
39013307275
39013407275 39013507275 39013607275
39013707275 39013807275
39013907275 39014107275
39014207275 39014307275 39014407275
39014507275
39014607275 39014707275 39014807275 39014907275
39015007275 39015107275 39015207275 39015307275;
b) Lot Numbers: 4207225241
and 4207261241;
c) Lot Numbers: 4307236990 and 4307270990
RECALLING FIRM/MANUFACTURER Nova Biomedical Corporation,
Waltham, MA
REASON Incorrect Results – Creatinine results
were lower than the laboratory reference method.
VOLUME OF PRODUCT IN
COMMERCE 133
meters
DISTRIBUTION Nationwide
PRODUCT Kodak DirectView Model DR 3000 System, Stationary X-ray System;
Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345,
6552319, 6552335,
CODE Serial
Numbers: 30000032, 30001001, 30001004, 30001006, 30001016, 30001020, 30001024,
30001036, 30001038, 30001040, 30001039, 30001042, 30001048, 30001043, 30001049,
30001044, 30001045, 30001046, 30001021
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Carestream Heath Inc., Rochester,
NY,
Manufacturer: Kodak Electronic Products
(Shanghai) Co., Ltd., Shanghai, Pudong, China. F
REASON Unintended Positioner Movement - The
U-Arm Positioner starts to move 1) without command from the operator and/or 2)
can unexpectedly start movement if the system is powered down and re-energized
after a collision has occurred with the Quantum Table.
VOLUME OF
PRODUCT IN COMMERCE 19
units
DISTRIBUTION Nationwide
PRODUCT Siemens Syngo Imaging System with VB30A version of software. Model
Number: 10014063,
CODE Serial
Numbers: 1005, 1065, 1076, 1112, 1202, 1242, 1269, 1278, 1279, and
1282
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens
Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions,
Erlangen, Germany.
REASON Inconsistent data - A
buffer overflow may occur between information system and picture system if the
system experiences a high load. (e.g. RIS/PACS communication is unusually
high)
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION Nationwide
PRODUCT
a) Siemens Primus Linear Accelerator System,
PRIMART MX Linear Accelerator System;
PRIMUS Mid, Part
Number: 1940035 and
PRIMART MX, Part Number: 5500371,
b) Siemens Mevatron Linear
Accelerator Systems:
KD2, K 7767, K 8067, KD, KDS and
KDS2,
Mevatron KD2, Part No.: 1940753;
Mevatron KD2, Part No.: 08515520;
Mevatron KD2-Part No.: 9822685;
Mevatron K 7767, Part
No.: 5694302;
Mevatron K 8067, Part No.: 5694401;
Mevatron KD, Part No.: 8319857;
Mevatron KDS, Part No.: 9401522;
Mevatron KDS2, Part No.:
9411588; and
Mevatron KDS2, Part No.:
9822693,
c) Siemens Mevatron
Linear Accelerator Systems;
Mevatron M 7440, Part No.:
5672977;
Mevatron M 6700, Part No.: 5693908;
Mevatron M 6730, Part No.: 5694005;
Mevatron M 7140, Part No.: 5694104;
Mevatron M 7400, Part
No.: 5694153;
Mevatron M 7445, Part No.: 5694203;
Mevatron M 6300, Part No.: 8317000;
Mevatron M 6740, Part No.: 8319758;
Mevatron MD, Part
No.: 8319808;
Mevatron ME, Part No.: 8490005;
Mevatron MDX, Part No.: 8496200;
Mevatron M2 6300, Part No.: 9401316;
Mevatron M2 6700, Part No.: 9401407;
Mevatron M2 6740, Part No.: 9401506;
Mevatron MD2, Part No.: 09401654;
and
Mevatron MDX-2, Part No.: 9401746,
CODE All Serial Numbers up to Serial Number:
3532
RECALLING FIRM/MANUFACTURER Siemens Medical
Solutions USA, Inc., Concord, CA,
REASON Door Hinge failures; loose or falling
off (Stationary Structure Doors).
VOLUME OF PRODUCT IN
COMMERCE 1,284 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL:
GM300,
CODE Lot Numbers: 1FF19C0001
to 1FF19C0020, 1FF05C0001 to 1FF05C5000, 2FH15C0001 to 2FH15C4800, 230GBB0001 to
230GBB0050, 230GFF0001 to 230GFF0600, 230GFF0601 to 230GFF1200, 230GFF1201 to
230GFF1996, 230GHC0001 to 230GHC3204, 230GHC3205 to 230GHC4204, 230GHJ0001 to
230GHJ5000, 230GHJ5001 to 230GHJ6992, and 230GIB0001 to
230GIB3008
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Invictus Scientific Inc., San Diego, CA,
Manufacturer: Bionime
Corporatio, Dall City, Taiwan.
REASON Abnormal Memory Recall: When
the meter is fixed in 12 hour mode, the time frame display of all memory data
will be shown incorrectly as AM or PM depending on when the user is recalling
the memory stored in the meter. This will cause confusion as to when the last
test was taken.
VOLUME OF PRODUCT IN
COMMERCE 21,070
DISTRIBUTION Nationwide
PRODUCT
a) Centurion Healthcare Products Laceration Tray, sterile; The
primary kit is labeled as
containing 1 needle, 21G x
1-1/2", among other components, however some kits may
contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety
Needle itself is the correct size. (Reorder SUT8805A),
b) Centurion Healthcare Products Laceration Tray,
sterile; The primary kit is labeled as
containing 1
needle, 21G x 1-1/2", among other components, however some kits
may
contain a 21Gx1" needle. The label on the Kendall
Monoject Magellan 21G Safety
Needle itself is the correct
size. (Reorder SUT8805A),
CODE
a)
Lot Number: 908207;
b) Lot Number: 907097
RECALLING
FIRM/MANUFACTURER Tri-State Hospital Supply Corporation, Howell, MI,
REASON
Incorrect Needle size: Some of the kits
contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on
the kit label.
VOLUME OF PRODUCT IN COMMERCE 436
kits
DISTRIBUTION Nationwide
PRODUCT
a) First Aid Kits, soft canvas, plastic, and metal containers
holding various products to
include ibuprofen and other
first aid supplies, in various sizes. Kits include:
Labeled with First Aid Only, Inc: Recreational Sports First Aid, Item SM-134;
Welder's First Aid Kit, Item 253-U;
Vehicle First Aid Kit, Item 220-0;
On-The-Road Auto First Aid, Item FAO-310;
Auto First Aid
Essentials, Item FAO-340;
Auto First Aid Essentials, Item
FDA-532;
Auto First Aid Essentials, Item FDA-552;
Vehicle First Aid Kit, Item 221-U;
Outdoor First Aid Kit, Item FAO-410;
Outdoor First Aid
Kit, Item FAO-410
Outdoor First Aid Kit, Item FAO-420;
Outdoor First Aid Kit, Item FAO-430;
Outdoor First Aid Kit, Item FAO-440;
First Aid & Survival Kit, Item
FA-462;
First Aid Kit, FAO-422-06;
First Aid Kit, 403-PC;
First Aid Response Kit, FA-504;
All Purpose First Aid Kit, Item FAO-112;
All Purpose First Aid Kit, Item
FAO-122;
All Purpose First Aid Kit, Item FAO-142;
All Purpose First Aid Kit, Item
FAO-432;
All Purpose First Aid Kit, Item FAO-444;
All Purpose First Aid Kit, Item FAO-452;
First Aid Essentials, Item FAO-130;
First Aid Essentials, Item FAO-132;
First Aid Essentials, Item FAO-134;
First Aid Essentials,
Item FAO-422;
First Aid Essentials, Item FAO-428;
First Aid Essentials, Item FAO-432;
First Aid Essentials, Item FAO-442;
Refillable First Aid Kit, FAO-490C;
Refillable First Aid Kit, FAO-490C;
Brite Stock first aid kits; Item FAO-130-BS; Item FAO-132-BS;
Item FAO-134-BS;
Lake & Trail
Outdoor First Aid Kit, Item MJR-420;
Lake & Trail
Outdoor First Aid Kit, Item MJR440;
First aid kits
labeled: meijer First Aid Kit, Item MJR-130;
meijer First
Aid Kit, Item MJR-442;
First Aid Kits labeled FIRST AID
Exchange:
General Purpose Home First Aid
Kit, Item 2800;
Auto First Aid Kit,
Item 2825;
First Aid Kit: All purpose First Aid Kit, Item
FAO-132-MS First Aid Kit;
Ready Solutions: First Aid Kit,
Item 90030;
First Aid Kit labeled NORTHERN Safety Co.,
Inc.:
First Aid Kit, Item FAO-442-NS;
First Aid Kit: Grafco First Aid Kit, Item
1799-9133
and First Aid Kit labeled -Provided by MOTURIS
LTD- Custom Kit,
Item 9099,
b)
First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen
tablets and a variety of other first aid supplies: Item
249-0/FAO Item 249-0/P Item
249-RK/P First Aid Exchange
brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-
0108 and
Item 1300-PAT-0109,
c) Ibuprofen tablet refills
in cardboard boxes or clear plastic bags for first aid kits and
cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen
Tablets, Item A405-WIP,
Item A405-10 Ibuprofen Tablets,
Item FAE-7014;; Ibuprofen Tablets, Item H430;
Ibuprofen
Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets,
item Z6100,
CODE
a) Lot Numbers are for kits and cabinets:
C0207, C0217, C0227, C0267, C0277, C0287,
C0297, C0307,
D0027, D0037, D0047, D0057, D0067, D0097, D0107, D0117,
D0127, D0137, D0167, D0177, D0187, D0197, D0207, D0247, D0267, E0027,
E0047, E0077, E0087, E0177, E0187, D0227, E0297, E0307,
E0317, F0017,
F0087, F0207, F0267, G0067, G0097, G0137,
G0187, G0257, H0017, H0157,
H0167, H0237, H0277, H0287,
H0297, H0307, H0317, I0047, I0057, I0107,
I0127, I0137,
I0177, I0187, I0197, I0207, I0217, I0247, I0251, I0277, I0287,
J0017, J0037, J0047, J0087, J0097, and J0117;
b) Lot
Numbers are for kits and cabinets: C0207, C0217, C0227, C0267, C0277,
C0287, C0297, C0307, D0027, D0037, D0047, D0057, D0067,
D0097, D0107,
D0117, D0127, D0137, D0167, D0177, D0187,
D0197, D0207, D0247, D0267,
E0027, E0047, E0077, E0087,
E0177, E0187, D0227, E0297, E0307, E0317,
F0017, F0087,
F0207, F0267, G0067, G0097, G0137, G0187, G0257, H0017,
H0157, H0167, H0237, H0277, H0287, H0297, H0307, H0317, I0047, I0057,
I0107, I0127, I0137, I0177, I0187, I0197, I0207, I0217,
I0247, I0251, I0277,
I0287, J0017, J0037, J0047, J0087,
J0097, and J0117;
c) Lot Code: HA09707 (exp. 12/09)
RECALLING
FIRM/MANUFACTURER First Aid Only, Inc., Vancouver, WA,
REASONFailed USP Impurity testing: the
Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet
refills, and cabinets, is being recalled for failing its USP limits for
impurities during stability testing.
VOLUME OF PRODUCT IN
COMMERCE 72,904 kits; 2,005 cabinets; 62,302
tablets
DISTRIBUTION Nationwide and Internationally
WEEK ENDING MARCH 8
PRODUCT American
Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number
0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia),
CODE
Lot Numbers 705 N
and 706 E
RECALLING FIRM/MANUFACTURER AMS Innovative
Center - San Jose, San Jose, CA,
REASON Control knob break: The knob used to
finely control the direction of the laser energy may break.
VOLUME OF
PRODUCT IN COMMERCE 611
units
DISTRIBUTION Nationwide and
Singapore
PRODUCT Smiths Medical
CADD-Sentry Pro Medication Safety Software –
electronic pump protocol programming software – Administrator REF 21-6275-51 RX
only,
CODE Software Version
B
RECALLING FIRM/MANUFACTURER Smiths Medical MD, Inc.,
Saint Paul, MN,
REASON Incorrect dosage possible: A software
anomaly in the CADD-Sentry Pro Administrator software (version B) where the
values of a weight based protocol go to zero or round up to the next higher
hundredths place, even if Administrator displayed the values correctly at data
entry.
VOLUME OF PRODUCT IN COMMERCE 3 CD-Rom’s
DISTRIBUTION
UT, MD,
CO
PRODUCT
a)
TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) # 7691;
Sterile,
b) TENET Medical
Engineering Wrist Stabilization Kit, Medium; REF (Part) # 7692;
Sterile,
c) TENET Medical
Engineering Wrist Stabilization Kit, Large; REF (Part) # 7693;
Sterile,
CODE a), b), and c) Lot Number:
20060605
RECALLING FIRM/MANUFACTURER Tenet Medical
Engineering, Inc., Calgary, Canada
REASON Sterility
compromised: Sterility seals on some of the firm’s wrist stabilization kit
pouches may be compromised.
VOLUME OF PRODUCT IN
COMMERCE 820
units
DISTRIBUTION Nationwide
PRODUCT Orthofix TrueLok External Ring Fixation System, Telescopic Linear
Distractor, 150mm; Catalog Number: 50-1015,
CODE Lot number: 2664-01
RECALLING
FIRM/MANUFACTURER Orthofix, Inc., Mckinney, TX,
REASON Markings reversed: Graduated markings on
telescoping bone distractors were reversed, causing the distractors to compress
rather than distract the treatment site when adjusted.
VOLUME OF
PRODUCT IN COMMERCE 16
units
DISTRIBUTION Nationwide
PRODUCT
a) Stryker Modular Replacement System Curved Cemented Stem; MRS SM
Curved
Femoral Stem 10x102; Catalog Number: 6485-3-300;
b) Stryker Modular Replacement System Curved Cemented
Stem; MRS Small Curved
Femoral Stem 8x102; Catalog Number
6485-3-308;
c) Stryker Modular Replacement System
Curved Cemented Stem; MRS Small Curved
Femoral Stem 9 x
102; Catalog Number: 6485-3-309;
d) Stryker Modular
Replacement System Curved Cemented Stem; MRS 11mmx203mm
femoral stem. Catalog Number: 6485-3-311;
e) Stryker
Modular Replacement System Curved Cemented Stem; MRS 12mmx203
Femoral Stem; Catalog Number: 6485-3-313;
f) Stryker Modular Replacement System Curved Cemented Stem; MRS
15mmx203mm
Femoral Stem; Catalog Number: 6485-3-315;
g) Stryker Modular Replacement System Curved Cemented
Stem; MRS 17mmx203
Femoral Stem; Catalog Number
6485-3-317;
h) Stryker Modular Replacement System
Curved Cemented Stem; MRS 11x127
Curved Femoral Stem;
Catalog Number: 6485-3-711;
i) Stryker Modular
Replacement System Curved Cemented Stem; MRS 13x127
Curved Femoral Stem; Catalog Number: 6485-3-713;
j)
Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved
Femoral Stem; Catalog Number: 6485-3-715;
k) Stryker Modular Replacement System Curved Cemented Stem; MRS
17x127 Curved
Femoral Stem; Catalog Number: 6485-3-717;
CODE
a) Lot Codes:
TEC023A, TEC023B, TEC082;
b) Lot Codes: LCDBP, TEC024A, TEC024B, TEC080A,
TEC080C;
c) Lot code TEC025A;
d) Lot Codes: LCDAR, TEC009A, TEC009B,
TEC009B1, TEC009C, TEC017A,
TEC017B, TEC017C, TEC121,
TEC122, TEC123, TEC124, TEC125, TEC125A,
TEC126, TEC127,
TEC246, TEC246A, TEC246A1, TEC246B, TECO17A,
TECO17B,
TECO17B1, TECO172B2, TECO17B3;
e) Lot codes: LCDAS, LPF008, SCAN, TEC018B,
TEC018C, TEC128, TEC129,
TEC130, TEC131, TEC247, TEC247A,
TEC247B, TECO18A, TECO18B;
f) Lot codes: D6TEBR, D6TECR, LCDAT, TEC019A,
TEC019A1, TEC019E,
TEC132A, TEC133, TEC134, TEC135,
TEC136,
g) Lot codes: LCCAS, LCCAS10, LCCAS11, LCCAS3, LCCAS9, LCDAU,
LCDAU11,
LCDAU13, LCDAU5, LCDAU6, LCDAU7, LCDAU9,
TEC138A, TEC139,
TEC140, TEC249B;
h) Lot code: LCDCD,
TEC010, TEC010A, TEC010A2, TEC026A, TEC026B,
TEC026C,
TEC026C1, TEC054B, TEC054D, TEC054E, TEC086A, TEC086A1,
TEC086A2, TEC086A3, TEC086A4, TEC086B, TEC086C, TEC086F, TEC086H,
TEC086I, TEC086J, TEC086J1, TEC256, TEC300B,
TEC300D;
i) Lot Codes: LCDCE, LCDE1, TEC027, TEC055, TEC055B, TEC055C,
TEC087,
TEC087A, TEC087A1, TEC087B, TEC087B1, TEC087C,
TEC087D, TEC097E,
TEC257, TEC283A;
j) Lot Codes: LCDCF, TEC056A, TEC056B, TEC088B, TEC088B1, TEC088C,
TEC088E, TEC088H, TEC141, TEC142, TEC258, TEC338;
k) Lot Codes: LCDCH,
TEC029A, TEC057A, TEC089B, TEC089C, TEC089D,
TEC089E,
TEC089E2, TEC089F, TEC089G, TEC089G1, TEC089H1, TEC089I1,
TEC144, TEC145, TE 259, TEC301
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Orthopaedi, Mahwah, NJ,
Manufacturer: Stryker
Orthopaedi, Limerick,
Ireland.
REASON Curvature Discrepancy: The radius of
curvature may be out of specification to varying degrees causing a discrepancy
in the stem curvature between trials and implants.
VOLUME OF PRODUCT
IN COMMERCE 803
units
DISTRIBUTION Nationwide
PRODUCT
a) Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro
diagnostic use.
This reagent system is composed of one
bottle of gentamicin antiserum, one bottle of
gentamicin
flourescein tracer and one bottle of pretreatment solution; List # 9512-60,
b) Abbott TDx/TDxFLx Gentamicin
Wedge Reagent - Is a reagent for in vitro
diagnostic use.
This reagent system is composed of one bottle of gentamicin
antiserum, one bottle of gentamicin flourescein tracer
and one bottle of
pretreatment solution; List #
9512-85,
c) Abbott AxSYM Gentamicin
Reagent - Is a reagent for in vitro diagnostic use.
This
reagent system is composed of one bottle of gentamicin antiserum, one bottle of
pretreatment solution and one bottle of gentamicin
flourescein tracer; List # 7A65-20;
CODE
a) Lot # 51187Q100 Exp Date:
09/17/08;
b) Lot # 51189Q100 Exp Date 09/17/08;
c) Lots # 53190Q100 Exp
Date 04/12/08 and Lot # 53190Q101 Exp Date 04/12/08
RECALLING
FIRM/MANUFACTURER Abbott Diagnostic International, Ltd., Barceloneta, PR
REASON
Incorrect Results -- Through
evaluation of stability, Abbott have found a decrease in the calibrator A to F
span with these reagents lots, which may produce the following results: Printed
Error Code "SPAN LESS THAN MIN SPAN" - Controls out of range. When a control is
out of range, patient results should not be reported.
VOLUME OF
PRODUCT IN COMMERCE 5,186
kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Advanced Bionics Precision Implantable Pulse Generator Kit,
Model Number:
SC-1110 with firmware version prior to
Revision 3.02,
b) Advanced Bionics Precision
Implantable Pulse Generator Kit, Model Number:
SC-1100
with firmware version prior to Revision 3.02,
CODE
a) Serial Numbers: 101507 163647 810125
701550 702047 802266 165125 165187 701799 11043 11702 100101 165271 802245
164445 163077 103643 103739 165066 164048 701001 160570 165819 165633 160654
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166263 102994 103274 162192 802631 103205 103301 160353 165037 165249 165286
103207 162774 164339 164573 164586 16007 100091 163571 802377 164932 164957
165176 161716 165152 165948 166041 800670 164896 701092 161856 164302 164319
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103407 103408 103411 103413 103414 103415 103416 103441 103448 103451 103453
103461 103463 103464 103465 103472 103476 103477 103478 103479 103480 103481
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103631 103633 103634 103636 103637 103638 103639 103641 103642 103644 103645
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103733 103735 103736 103738 160001 160002 160003 160004 160005 160009 160011
160012 160013 160014 160015 160016 160017 160018 160019 160020 160022 160023
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162825 162826 162828 162829 162830 162831 162832 162833 162835 162836 162837
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163005 163006 163007 163008 163009 163010 163012 163013 163015 163016 163017
163019 163020 163021 163022 163024 163025 163026 163027 163029 163031 163033
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163124 163125 163126 163127 163128 163129 163130 163131 163133 163134 163135
163139 163140 163141 163142 163143 163144 163146 163148 163149 163150 163151
163152 163155 163157 163159 163160 163161 163162 163163 163164 163165 163168
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163247 163248 163249 163250 163252 163253 163254 163255 163257 163258 163259
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163289 163290 163291 163292 163294 163295 163296 163297 163298 163299 163300
163301 163302 163303 163305 163306 163308 163309 163310 163311 163312 163313
163315 163316 163317 163318 163319 163325 163326 163327 163328 163329 163330
163331 163333 163334 163335 163336 163337 163338 163340 163341 163342 163343
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163389 163390 163391 163392 163393 163394 163395 163397 163398 163399 163400
163401 163402 163403 163404 163405 163407 163408 163409 163410 163414 163415
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163529 163530 163531 163532 163533 163534 163535 163536 163537 163538 163541
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163662 163663 163664 163665 163666 163667 163669 163670 163671 163672 163674
163675 163676 163677 163678 163679 163680 163685 163686 163687 163689 163690
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800446 800447 800448 800450 800453 800455 800458 800459 800460 800463 800474
800476 800478 800485 800486 800488 800490 800498 800501 800505 800510 800511
800518 800519 800521 800524 800527 800534 800535 800536 800538 800541 800542
800545 800546 800548 800553 800554 800558 800564 800566 800574 800575 800577
800581 800583 800587 800590 800597 800599 800604 800605 800607 800613 800616
800619 800620 800624 800626 800628 800631 800632 800635 800639 800644 800647
800648 800649 800653 800655 800657 800658 800659 800660 800666 800667 800668
800671 800673 800674 800677 800680 800681 800683 800684 800685 800687 800688
800689 800690 800691 800692 800695 800698 800699 800705 800706 800709 800710
800711 800713 800715 800717 800719 800737 800747 800750 800752 800756 800757
800759 800761 800763 800765 800767 800771 800772 800776 800778 800780 800781
800782 800783 800784 800787 800788 800789 800795 800799 800804 800805 800807
800814 800816 800817 800819 800820 800824 800830 800841 800842 800850 800860
800864 800869 800872 800874 800877 800882 800884 800889 800895 800897 800899
800902 800905 800907 800910 800916 800917 800920 800921 800922 800924 800926
800929 800934 800937 800948 800949 800956 800957 800958 800961 800964 800965
800966 800969 800970 800974 800978 800980 800981 800985 800988 800995 800996
800999 801004 801006 801008 801010 801012 801013 801014 801018 801020 801026
801028 801029 801032 801033 801034 801039 801040 801041 801042 801046 801047
801055 801056 801059 801060 801062 801063 801066 801067 801071 801072 801075
801076 801079 801080 801082 801086 801089 801096 801098 801099 801100 801106
801112 801114 801117 801119 801122 801123 801131 801132 801134 801135 801138
801140 801141 801142 801144 801147 801151 801153 801154 801158 801159 801161
801163 801164 801167 801168 801171 801176 801179 801180 801182 801191 801192
801193 801200 801202 801203 801206 801207 801208 801213 801214 801218 801219
801221 801224 801226 801235 801236 801237 801239 801241 801243 801244 801245
801247 801252 801256 801260 801261 801262 801264 801265 801267 801269 801270
801277 801279 801280 801282 801286 801289 801290 801292 801293 801294 801296
801298 801302 801305 801308 801311 801314 801315 801320 801321 801326 801327
801328 801330 801332 801335 801336 801343 801352 801354 801357 801358 801359
801362 801370 801379 801381 801385 801386 801389 801394 801395 801397 801399
801400 801402 801404 801405 801412 801414 801419 801422 801424 801425 801427
801439 801446 801455 801456 801458 801467 801470 801473 801474 801475 801476
801478 801480 801482 801484 801485 801486 801487 801488 801494 801496 801500
801503 801512 801513 801515 801516 801517 801519 801520 801527 801528 801534
801544 801553 801557 801559 801562 801565 801567 801569 801570 801579 801585
801588 801596 801608 801609 801614 801617 801622 801625 801626 801627 801629
801635 801637 801638 801640 801644 801647 801653 801656 801659 801663 801667
801672 801673 801677 801680 801683 801687 801698 801699 801702 801707 801712
801713 801717 801718 801721 801722 801723 801724 801734 801735 801737 801742
801744 801745 801746 801747 801757 801758 801761 801764 801768 801771 801772
801776 801778 801779 801793 801796 801799 801800 801801 801805 801806 801808
801811 801814 801815 801816 801818 801819 801821 801822 801823 801824 801828
801829 801830 801831 801832 801833 801834 801837 801839 801842 801845 801847
801848 801851 801854 801858 801859 801864 801865 801867 801869 801870 801872
801874 801876 801880 801884 801896 801897 801898 801899 801901 801903 801904
801906 801915 801921 801922 801924 801925 801926 801928 801929 801931 801932
801936 801940 801941 801945 801946 801948 801949 801950 801952 801953 801955
801958 801959 801960 801961 801962 801963 801965 801966 801967 801968 801969
801970 801971 801972 801975 801976 801979 801980 801982 801983 801984 801985
801986 801987 801989 801990 801992 801994 801996 801997 801999 802004 802085
802087 802092 802093 802098 802099 802101 802102 802105 802108 802109 802111
802113 802115 802116 802117 802118 802119 802123 802125 802127 802129 802130
802132 802135 802138 802141 802143 802144 802145 802149 802151 802152 802153
802154 802155 802156 802160 802162 802163 802165 802166 802170 802171 802172
802175 802176 802178 802179 802182 802184 802187 802188 802189 802190 802192
802194 802196 802197 802202 802203 802204 802205 802208 802211 802212 802213
802214 802215 802216 802217 802218 802223 802224 802225 802226 802229 802232
802233 802234 802235 802236 802237 802241 802242 802243 802244 802246 802248
802249 802250 802251 802252 802254 802255 802257 802262 802265 802271 802273
802274 802276 802277 802278 802279 802280 802283 802284 802286 802295 802297
802300 802301 802302 802303 802304 802305 802306 802308 802311 802313 802315
802317 802318 802321 802322 802323 802324 802326 802328 802329 802331 802333
802335 802339 802340 802342 802346 802349 802351 802352 802354 802355 802356
802357 802358 802359 802362 802363 802364 802365 802366 802367 802368 802369
802371 802372 802374 802375 802376 802380 802385 802386 802389 802390 802392
802400 802408 802414 802420 802421 802426 802432 802437 802439 802446 802449
802450 802453 802455 802456 802457 802461 802462 802463 802465 802466 802467
802471 802476 802479 802480 802485 802486 802488 802489 802491 802493 802494
802495 802497 802499 802500 802501 802502 802506 802507 802508 802511 802515
802517 802519 802520 802524 802525 802537 802538 802543 802544 802546 802547
802550 802551 802552 802553 802554 802555 802559 802561 802562 802565 802567
802572 802573 802575 802577 802579 802580 802581 802582 802583 802586 802594
802598 802600 802601 802604 802605 802606 802608 802610 802611 802612 802613
802616 802619 802621 802623 802625 802627 802628 802637 802640 802642 802645
802646 802647 802650 802651 802652 802655 802657 802658 802659 802661 802662
802665 802666 802667 802668 802670 802671 802674 802675 802677 802679 802681
802682 802685 802690 802691 802693 802697 802699 802700 802701 802702 802703
802706 802710 802716 802717 802718 802719 802720 802721 802722 802723 802725
802728 802733 802734 802743 802745 802746 802749 802752 802754 802757 802760
802764 802767 802768 802769 802772 802773 802775 802778 802780 802782 802786
802787 802788 802789 802790 802791 802795 802799 802803 802804 802805 802806
802808 802809 802812 802819 802823 802827 802828 802829 802830 802831 802832
802833 802835 802837 802838 802839 802840 802843 802844 802845 802846 802848
802852 802854 802855 802856 802857 802858 802861 802864 802870 802872 802873
802875 802876 802878 802879 802880 802883 802885 802886 802889 802890 802892
802893 802896 802897 802902 802903 802905 802907 802908 802910 802912 802924
802925 802926 802929 802931 802932 802934 802935 802939 802942 802948 802949
802952 802957 802958 802959 802960 802964 802971 802972 802973 802976 802981
802982 802985 802986 802988 802990 802991 802993 802994 802995 802996 802997
803000 803002 803004 803005 803009 803011 803012 803014 803015 803016 803018
803020 803022 803024 803025 803026 803027 803028 803029 803030 803031 803032
803033 803034 803035 803036 803037 803038 803039 803041 803044 803046 803047
803048 803051 803053 803054 803055 803056 803058 803059 803060 803061 803062
803063 803064 803067 803068 803069 803070 803072 803073 803074 803075 803077
803079 803081 803082 803085 803086 803088 803089 803090 803097 803098 803100
803101 803102 803104 803106 803107 803109 803110 803111 803112 803115 803116
803117 803118 803120 803124 803125 803126 803127 803128 803130 803131 803134
803135 803138 803139 803140 803141 803143 803144 803145 803147 803148 803149
803150 803151 803152 803155 803159 803160 803161 803163 803164 803165 803172
803173 803174 803176 803177 803178 803179 803180 803183 803187 803188 803189
803191 803192 803193 803196 803198 803200 803203 803209 803210 803211 803214
803216 803217 803218 803220 803224 803226 803227 803228 803230 803231 803233
803235 803236 803243 803246 803249 803250 803251 803253 803255 803256 803260
803262 803263 803264 803265 803270 803271 803274 803275 803277 803279 803281
803284 803287 803288 803289 803290 803293 803294 803296 803297 803298 803300
803316 803317 803320 803321 803323 803325 803329 803331 803332 803334 803336
803338 803341 803342 803362 803440 803441 803442 803443 803444 803445 803446
803448 803450 803454 803456 803460 803462 803463 803466 803484 803485 803486
803491 803492 803503 803504 803505 803507 803510 803512 803513 803515 803516
803517 803518 803519 803521 803523 803526 803527 803537 803559 803560 803563
803564 803568 803569 803570 803572 803573 803574 803577 803579 803580 803583
803588 803590 803592 803596 803599 803600 803605 803608 803613 803614 803617
803621 803622 803623 803626 803628 803629 803630 803631 803632 803633 803635
803636 803637 803638 803641 803642 803646 803648 803652 803653 803656 803658
803659 803662 803668 803669 803670 803673 803675 803676 803678 803682 803683
803685 803687 803690 803694 803695 803696 803697 803698 803699 803701 803702
803704 803705 803706 803707 803708 803739 803741 803743 803748 803750 803751
803752 803754 803756 803759 803761 803763 803767 803768 803769 803770 803771
803775 803777 803779 803780 803781 803784 803786 803789 803791 803792 803793
803794 803796 803799 803800 803803 803807 803808 803809 803810 803812 803814
803816 803819 803821 803822 803823 803824 803825 803826 803827 803829 803830
803831 803835 803836 803838 803840 803843 803845 803846 803847 803848 803850
803851 803853 803857 803859 803861 803863 803864 803865 803867 803868 803871
803872 803875 803877 803879 803927 803929 803931 804031 804032 804035 804038
804039 804040 804041 804044 804045 804048 804052 804055 804056 804058 804091
804093 804096 804097 804098 804099 804100 804101 804102 804103 804107 804109
804110 804112 804113 804114 804115 804116 804117 804118 804119 804128 804137
804150 804152 804153 804156 804164 804168 804169 804171 804175 804177 804179
804181 804182 804185 804186 804193 804195 804198 804199 804210 804237 804267
804277 804322 804323 804331 804334 804335 804336 804337 804339 804340 804350
804356 804357 804359 804390 804393 804398 804436 804437 804439 804442 804444
804447 804449 804451 804452 804453 804455 804456 804461 804463 804464 804557
804565 804575 804584 804616 804617 804619 804621 804623 804627 804628 804631
804633 804634 804635 804637 804640 804641 804642 804683 804685 804686 804689
804690 804692 804694 804705 804826 804838 804841 804843 810001 810006 810007
810009 810011 810014 810015 810016 810017 810020 810021 810022 810024 810027
810028 810029 810030 810032 810033 810034 810036 810042 810043 810044 810047
810049 810050 810051 810053 810054 810057 810058 810061 810066 810069 810070
810071 810079 810080 810083 810084 810085 810087 810090 810091 810092 810094
810095 810097 810098 810100 810102 810103 810112 810115 810117 810119 810120
810121 810122 810123 810127 810129 810131 810132 810135 810136;
b)
Serial Numbers: 367 379 408 418 429 432 435 436 438 462 467 473 490 601 608 625
636 655 660 661 666 667 671 679 681 683 685 691 696 712 715 719 724 731 732 734
744 745 748 770 1011 1012 1015 1016 1017 1022 1024 1027 1030 1035 1038 1044 1046
1048 1051 1053 1056 1065 1066 1068 1076 1077 1079 1083 1085 1090 1091 1093 1094
1095 1096 1102 1103 1105 1108 1111 1115 1117 1121 1129 1131 1141 1142 1146 1149
1153 1154 1158 1159 1161 1164 1167 1168 1169 1170 1171 1177 1179 1180 1185 1186
1188 1190 1191 1213 1214 1218 1219 1220 1221 1222 1224 1225 1226 1231 1232 1233
1237 1238 1240 1241 1242 1245 1246 1257 1266 1267 1269 1272 1273 1274 1277 1280
1283 1285 1286 1401 1403 1404 1406 1408 1409 1412 1413 1414 1416 1420 1421 1426
1428 1429 1431 1432 1435 1437 1443 1444 1445 1446 1447 1448 1451 1458 1459 1464
1500 1502 1503 1508 1509 1511 1512 1513 1517 1519 1522 1526 1527 1528 1529 1530
1532 1535 1536 1541 1545 1550 1552 1554 1556 1558 1561 1563 1565 1566 1567 1568
1575 1578 1582 1583 1586 1587 1589 1593 1595 1596 1602 1605 1606 1608 1612 1613
1617 1620 1621 1622 1627 1630 1633 1634 1635 1637 1638 1639 1643 1645 1646 1647
1649 1650 1653 1654 1656 1659 1660 1661 1662 1665 1669 1670 1673 1682 1685 1686
1693 1696 1697 1698 1699 1706 1710 1711 1712 1713 1714 1715 1716 1718 1723 1731
1733 1739 1743 1744 1745 1746 1748 1749 1753 1756 1757 1758 1759 1763 1765 1767
1768 1769 1771 1774 1777 1779 1782 1783 1785 1786 1790 1791 1792 1794 1795 1796
1801 1806 1807 1808 1811 1812 1818 1819 1822 1825 1828 1831 1835 1836 1838 1839
1844 1845 1853 1855 1869 1871 1874 1878 1886 1893 1894 1896 1898 1899 2001 2003
2004 2005 2007 2011 2013 2015 2016 2018 2022 2024 2025 2027 2028 2031 2033 2034
2037 2040 2041 2042 2044 2046 2048 2054 2056 2057 2058 2061 2065 2066 2067 2070
2071 2072 2073 2075 2081 2083 2092 2094 2098 2102 2109 2111 2119 2124 2127 2132
2134 2138 2142 2150 2153 2158 2160 2163 2167 2168 2177 2178 2180 2182 2185 2191
2192 2199 2209 2212 2215 2221 2224 2238 2241 2242 2243 2246 2249 2251 2252 2257
2260 2262 2265 2268 2271 2275 2277 2278 2279 2283 2284 2285 2289 2291 2294 2295
2296 2299 2301 2305 2307 2311 2314 2317 2321 2328 2329 2334 2344 2346 2348 2352
2353 2363 2367 2368 2372 2376 2377 2378 2379 2380 2382 2387 2390 2391 2394 2397
2398 2401 2402 2403 2406 2408 2411 2412 2413 2418 2419 2425 2427 2430 2433 2437
2439 2441 2443 2445 2449 2452 2455 2457 2459 2460 2461 2466 2470 2473 2474 2475
2476 2488 2489 2496 2497 2498 2501 2502 2508 2513 2519 2521 2522 2523 2529 2531
2532 2545 2547 2548 2550 2556 2559 2562 2566 2575 2577 2582 2588 2591 2594 2596
2602 2603 2604 2610 2611 2619 2621 2630 2631 2632 2633 2637 2640 2646 2647 2648
2661 2665 2680 2681 2682 2684 2689 2694 2695 2698 2699 2706 2718 2723 2725 2726
2727 2728 2737 2739 2745 2746 2749 2752 2753 2766 2768 2777 2785 2805 2815 2819
2826 2827 2828 2840 2843 2844 2845 2848 2853 2854 2855 2857 2859 4156 4167
4172
RECALLING FIRM/MANUFACTURER Advanced Bionics Corp.,
Sylmar CA,
REASON Incorrect Data -- Corruption of internal memory
component results in an inability for the physician to reprogram the IPG with
firmware version prior to Revision 3.02. When this occurs, the IPG will report
an error code of "10h0" or "00h0" through the Remote Control. Under this
condition, the IPG will cease to log in some data that could be used for
informational purposes. ** It should be noted that there is no effect to the
actual functionality of the IPG.**
VOLUME OF PRODUCT IN
COMMERCE Over 12,000
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) BHM Medical Scales, 800 lb. scale weight limit; Part Number
700.00510. These
scales were sold for installation on or
as a component of the following patient lifts:
a): Part
Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift;
Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with
Scale Patient Lift;
Part Number: ERGOLIFT-2 + SC,
Ergolift 400 Lbs with Scale Patient Lift;
b) Part Number
: 700.05610.06, Hoyer-600 Spreader Bar with Scale;
Part
Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale,
Model HPL-600WBSC; Part Number: 9600132.06,
Hoyer-600 Wide Opening
Patient Lifter with Scale,
b) BHM Medical Scales, 1000 lb. scales weight limit;
Part Number 700.00525;
These scales were sold for
installation on the Model V10 and Model Maxisky fixed
ceiling lifts. Part 700.00525,
CODE
a) Part Number 700.00510, a)
Serial Numbers :ERSC-3044, ERSC-3060, ERSC-5318,
ERSC-5323, ERSC-5324, ERSC-5907, ERSC-5967, ERSC-6032,
ERSC-6073,
ERSC-6232, ERSC-6316, ERSC-6326, ERSC-6354,
ERSC-6355, ERSC-6357,
ERSC-6365, ERSC-6372, ERSC-6532,
ERSC-6703, ERSC-6716, ERSC-6717,
ERSC-6719, ERSC-7024,
ERSC-7025, ERSC-7060, ERSC-7064, ERSC-7347,
ERSC-7351,
ERSC-7532, ERSC-7551, ERSC-7553, ERSC-7554, ERSC-7555,
ERSC-7556, ERSC-7559, ERSC-7560, ERSC-7561, ERSC-7562, ERSC-7565,
ERSC-7566, ERSC-7567, ERSC-7614, ERSC-7617, ERSC-7623,
ERSC-7625,
ERSC-7665, ERSC-7709, ERSC-8487, ERSC-8488,
ERSC-8492, ERSC-8498,
ERSC-8500, ERSC-8501, ERSC-8503,
ERSC-8509, ERSC-8561, ERSC-8565,
ERSC-8632, ERSC-8634,
ERSC-8635, ERSC-8638, ERSC-8644, ERSC-8648,
ERSC-8658,
ERSC-8675, ERSC-8834, ERSC-8848, ERSC-8874, ERSC-8883,
ERSC-8886, ERSC-8887, ERSC-8890, ERSC-8894, ERSC-8896, ERSC-8899,
ERSC-8900, ERSC-8918, ERSC-8920, ERSC-8921, ERSC-8923,
ERSC-8924,
ERSC-8925, ERSC-8927, ERSC-8992, ERSC-9348, and
ERSC-9361;
a) Part Number 88570101, Serial Numbers:
885-0100. 885-0104, 885-0105,
885-0139, 885-0210,
885-0211, 885-0218, 885-0219, 885-0220, 885-0266,
885-0267, 885-0269, 885-0273, 885-0275, and 885-2676;
Part Number ERGOLIFT-600+SC, Serial Numbers: ER600-1402, ER600-1406,
ER600-1435, ER600-1436, ER600-1437, ER600-1438,
ER600-1460, ER600-1475,
ER600-1476, ER600-1477,
ER600-1478, ER600-1479, ER600-1480, ER600-1481,
ER600-1483, ER600-1484, ER600-1485, ER600-1486, ER600-1515, ER600-1517,
ER600-1594, ER600-1671, ER600-1672, ER600-1673,
ER600-1674, ER600-1675,
ER600-1676, ER600-1677,
ER600-1721, ER600-1722, ER600-1724, ER600-1803,
ER600-1988, ER600-1989, ER600-1990, ER600-1991, ER600-1992, and
ER600-
2070;
Part Number ERGOLIFT-2
+ SC, Serial Numbers: ERLI-1471, ERLI-1472, ERLI-
1473,
ERLI-1474, ERLI-3046, ERLI-3144, ERLI-3145, ERLI-3146, ERLI-3232,
ERLI-3271, ERLI-3390, ERLI-3391, ERLI-3392, ERLI-3398,
ERLI-3436, ERLI-
3466, ERLI-3471, ERLI-3496, ERLI-3508,
and ERLI-3526;
b) Part Number 700.05610.06, Serial
numbers: 5427, 5428, 5639, 5640, 5641, 5642,
5644, 5645,
5646, 5647, 5657, 5658, 5913, 5915, 5916, 5917, 5918, 5919, 5920,
5962, 5985, 5986, 5987, 5988, 5989, 5990, 5991, 5992,
5993, 5994, 5995, 5996,
5997, 5998, 5999, 6000, 6001,
6002, 6003, 6004, 6005, 6006, 6007, 6008, 6009,
6010,
6011, 6013, 6014, 6015, 6016, 6017, 6020, 6042, 6045, 6046, 6050, 6053,
6054, 6056, 6099, 6100, 6101, 6102, 6103, 6104, 6105,
6106, 6107, 6108, 6109,
6110, 6111, 6112, 6113, 6114,
6115, 6116, 6119, 6120, 6123, 6129, 6135, 6136,
6137,
6138, 6139, 6140, 6141, 6142, 6143, 6144, 6145, 6146, 6147, 6148,
6149,
6150, 6151, 6152, 8424, 8425, 8426, 8427, 8428,
8429, 8433, 8434, 8435, 8436
8437, 8438, 8439, 8440,
8441, 8460, 8461, 8462, 8463, 8464, 8465, 8466, 8467,
8468, and 8469;
Part Number 9600102.06, Serial Numbers:
ER600-1330, ER600-1331, ER600-1332,
ER600-1333,
ER600-1334, ER600-1335, ER600-1336, ER600-1337, ER600-1338,
ER600-1339, ER600-1377, ER600-1379, ER600-1380,
ER600-1381, ER600-1382,
ER600-1383, ER600-1384,
ER600-1561, ER600-1562, ER600-1563, ER600-1564,
ER600-1565, ER600-1566, ER600-1567, ER600-1568, ER600-1569, ER600-1570,
ER600-1571, ER600-1572, ER600-1573, ER600-1574,
ER600-1575, ER600-1576,
ER600-1577, ER600-1578,
ER600-1579, ER600-1580, ER600-1581, ER600-1582,
ER600-1583, ER600-1584, ER600-1585, ER600-1586, ER600-1587,
ER600-1588,
ER600-1589, ER600-1590, ER600-1641,
ER600-1642, ER600-1643, ER600-1644,
ER600-1645, ER600-1646, ER600-1647, ER600-1648, ER600-1649, ER600-1650,
ER600-1651, ER600-1652, ER600-1653, ER600-1654,
ER600-1655, ER600-1656,
ER600-1657, ER600-1658, ER600-1659, ER600-1660, ER600-1755, ER600-1756,
ER600-1757, ER600-1758, ER600-1759, ER600-1760,
ER600-1761, ER600-1762,
ER600-1763, ER600-1764, ER600-1765, ER600-1766, ER600-1767, ER600-1768,
ER600-1769, ER600-1770, ER600-1771, ER600-1772,
ER600-1773, ER600-1774,
ER600-1854, ER600-1855,
ER600-1856, ER600-1857, ER600-1858, ER600-1859,
ER600-1860, ER600-1861, ER600-1862, ER600-1863, ER600-1864, ER600-1865,
ER600-1866, ER600-1867, ER600-1868, ER600-1869,
ER600-1870, ER600-1871,
ER600-1872, ER600-1873,
ER600-1874, ER600-1875, ER600-1876, ER600-1877,
ER600-1878, ER600-1879, ER600-1880, ER600-1881, ER600-1882, ER600-1883,
ER600-1948, ER600-1949, ER600-1950, ER600-1951,
ER600-1952, ER600-1953,
ER600-1954, ER600-1955,
ER600-1956, ER600-1957, ER600-1958, ER600-1959,
ER600-1960, ER600-1961, ER600-1962, ER600-1963, ER600-1964, ER600-1965,
ER600-1966, ER600-1967, ER600-2014, ER600-2015,
ER600-2016, ER600-2017,
ER600-2018, ER600-2019,
ER600-2020, ER600-2021, ER600-2022, ER600-2023,
ER600-2024, ER600-2025, ER600-2026, ER600-2027, ER600-2028, ER600-2029,
ER600-2030, ER600-2031, ER600-2032, and
ER600-2033;
Part Number 9600132.06, Serial Numbers:
ER600-2146, ER600-2147, ER600-2148,
ER600-2149,
ER600-2150, ER600-2151, ER600-2154, ER600-2155, ER600-2156,
ER600-2157, ER600-2158, ER600-2159, ER600-2160,
ER600-2161, ER600-2162,
ER600-2163, ER600-2164,
ER600-2165, ER600-2166, ER600-2167, ER600-2168,
ER600-2169, ER600-2170, ER600-2320, ER600-2321, ER600-2322, ER600-2323,
ER600-2324, ER600-2325, ER600-2326, ER600-2327,
ER600-2328, ER600-2329,
ER600-2330, ER600-2331,
ER600-2332, ER600-2333, ER600-2334, ER600-2335,
ER600-2336, ER600-2337, ER600-2338, ER600-2339, ER600-2340, ER600-2341,
ER600-2342, ER600-2343, ER600-2344, ER600-2345,
ER600-2346, ER600-2347,
ER600-2348, ER600-2349,
ER600-2350, ER600-2351, ER600-2352, ER600-2353,
ER600-2354, ER600-2355, ER600-2356, ER600-2357, ER600-2358,
ER600-2359,
ER600-2421, ER600-2422, ER600-2423,
ER600-2424, ER600-2425, ER600-2426,
ER600-2427,
ER600-2428, ER600-2429, ER600-2430, ER600-2431, ER600-2432,
ER600-2433, ER600-2434, ER600-2435, ER600-2436,
ER600-2437, ER600-2438,
ER600-2448, ER600-2449,
ER600-2450, ER600-2451, ER600-2452, ER600-2453,
ER600-2454, ER600-2455, ER600-2456, ER600-2457, ER600-2458, ER600-2459,
ER600-2460, ER600-2461, ER600-2462, ER600-2463,
ER600-2464, ER600-2465,
ER600-2466, ER600-2467,
ER600-2468, ER600-2469, ER600-2492, ER600-2493,
ER600-2494, ER600-2495, ER600-2497, ER600-2498, ER600-2499, ER600-2500,
ER600-2501, ER600-2502, ER600-2503, ER600-2504,
ER600-2505, ER600-2506,
ER600-2507, ER600-2508,
ER600-2509, ER600-2510, ER600-2511, ER600-2512,
ER600-2513, ER600-2514, ER600-2515, ER600-2516, ER600-2517, ER600-2518,
ER600-2519, ER600-2520, ER600-2521, ER600-2522,
ER600-2523, ER600-2524,
ER600-2525,
ER600-2526, ER600-2527, ER600-2528, ER600-2529, ER600-2530,
ER600-2531, ER600-2532, ER600-2533, ER600-2534,
ER600-2535, ER600-2536,
ER600-2537, ER600-2538,
ER600-2539, ER600-2540, ER600-2541, ER600-2542,
ER600-2543, ER600-2544, ER600-2545, ER600-2546, ER600-2547, ER600-2548,
ER600-2549, ER600-2550, ER600-2551, ER600-2552,
ER600-2553, ER600-2554,
ER600-2555, ER600-2556,
ER600-2557, ER600-2558, ER600-2559, ER600-2560,
ER600-2561, ER600-2562, ER600-2563, ER600-2564, ER600-2565, ER600-2566,
ER600-2567, ER600-2568, ER600-2569, ER600-2570,
ER600-2571, ER600-2572,
ER600-2573, ER600-2574,
ER600-2575, ER600-2576, ER600-2577, ER600-2578,
ER600-2579, ER600-2580, ER600-2581, ER600-2582, ER600-2583, ER600-2584,
ER600-2585, ER600-2586, ER600-2587, ER600-2588,
ER600-2589, ER600-2590,
ER600-2591, ER600-2592,
ER600-2593, ER600-2594, ER600-2595, ER600-2596,
ER600-2597, ER600-2598, ER600-2599, ER600-2600, ER600-2601, ER600-2602,
ER600-2603, ER600-2604, ER600-2605, ER600-2606,
ER600-2607, ER600-2608,
ER600-2609, ER600-2610,
ER600-2611, ER600-2612, ER600-2613, ER600-2614,
ER600-2615, ER600-2616, ER600-2617, ER600-2618, ER600-2619, ER600-2620 ,
ER600-2621, ER600-2622, ER600-2623,
ER600-2624, ER600-2625, ER600-2626,
ER600-2627, ER600-2628, ER600-2629, ER600-2630, ER600-2631, ER600-2632,
ER600-2633, ER600-2634, ER600-2635, ER600-2636,
ER600-2764, ER600-2765,
ER600-2766,
ER600-2767, ER600-2768, ER600-2769, ER600-2770, ER600-2771,
ER600-2772, ER600-2773, ER600-2774, ER600-2775,
ER600-2776, ER600-2777,
ER600-2778, ER600-2779,
ER600-2780, ER600-2781, ER600-2782, ER600-2783,
ER600-2784, ER600-2785, ER600-2786, ER600-2787, ER600-2788, ER600-2789,
ER600-2790, ER600-2791, ER600-2792, ER600-2793,
ER600-2794, ER600-2795,
ER600-2818, ER600-2819,
ER600-2820, ER600-2821, ER600-2822, ER600-2823,
ER600-2824, ER600-2825, ER600-2826, ER600-2827, ER600-2838, ER600-2839,
ER600-2840, ER600-2841, ER600-2842, ER600-2843,
ER600-2844, ER600-2845,
ER600-2846, ER600-2847,
ER600-2848, ER600-2849, ER600-2850, ER600-2851,
ER600-2852, ER600-2853, ER600-2854, ER600-2855, ER600-2856,
ER600-2857,
ER600-2858, ER600-2859, ER600-2882,
ER600-2883, ER600-2884, ER600-2885,
ER600-2886,
ER600-2887, ER600-2888, ER600-2889, ER600-2910, ER600-2911,
ER600-2912, ER600-2913, ER600-2914, ER600-2915,
ER600-2916, ER600-2917,
ER600-2918,
ER600-2919, ER600-2920, and ER600-2921;
b) Serial Numbers: ERSC-3064,
ERSC-3065, ERSC-3066, ERSC-3068, ERSC-5858,
ERSC-5859,
ERSC-5860, ERSC-5861, ERSC-5864, ERSC-5866, ERSC-6765,
ERSC-6767, ERSC-6768, ERSC-7729, ERSC-7742, ERSC-7769, ERSC-7776,
ERSC-7779, ERSC-7780, ERSC-7781, ERSC-7784, ERSC-7787,
ERSC-7789,
ERSC-7790, ERSC-7791, and
ERSC-8038
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Arjo, Inc. Roselle, IL,
Manufacturer: B.H.M. Medical, Inc., Magog, Canada.
REASON
Unintended Hanger Bar Detachment: The
locknut on the scales may loosen during use and allow the hanger bar assembly of
the patient lift to detach and fall.
VOLUME OF PRODUCT IN
COMMERCE 798
scales
DISTRIBUTION Nationwide
WEEK ENDING MARCH 15
PRODUCT BD
Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with
OS X operating systems,
CODE Software Versions 2.1, 2.1.1, and 2.2
with OS X operating systems
RECALLING
FIRM/MANUFACTURER BD Biosciences, San Jose, CA,
REASON Inaccurate results: Software error results in
inaccurate display result statistics. If the user adjusts the lymph gate or
attractors in the Lab Report view without using the Manual Gate function (as
described in the system manual), the statistic results will not be updated to
match the adjusted gate.
VOLUME OF PRODUCT IN
COMMERCE 1,136 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550,
Electrosurgical
Suction Tip,
b)
Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551,
Electrosurgical
Suction Tip,
CODE
a) Lot Number: 07297FE2;
b) Lot
Number: 07298FE2
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Stryker Endoscopy, San Jose, CA,
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR.
REASON
Cannot connect:
Tips have electrodes that are too large to fit monopolar cables and are
unusable.
VOLUME OF PRODUCT IN COMMERCE
a) 59 boxes of 6
(354 units),
b) 8 boxes of 6 (48
units)
DISTRIBUTION Nationwide
PRODUCT Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number:
04745914001,
CODE All cce and cc
system configurations with core unit software version
02-03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche
Diagnostics Corp., Indianapolis, IN,
Manufacturer: Division, Hitachi Ltd.,
Hitachinaka-Ibaraki, Japan.
REASON Incorrect results: CRP assays may be calculated
using incorrect calibration parameters which could result in falsely high or
falsely low patient results being reported.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION NE
PRODUCT Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose
Diagnostic Ultrasound system, Model Number: 8247887,
CODE
Serial Numbers: 32118 30032 33270 31789
30264 32770 33492 34115 22353203 40039-1 33468 33732 33808 33867 33906 33972
34080 34085 34104 34161 34168 34174 40009 40024 40046 40062 40093 40094 40101
40102 40132 40148 40163 40178 40187 40189 40197 40257 32603 33548 32611 30509
30991 31397 31770 31824 32018 32090 32551 32738 32927 31214 31518 30803 30828
31805 31875 33209 32053 32319 32497 32531 32830 33505 33421 32140 33515 33347
31997 30640 32141 32208 32209 32251 32450 32582 32625 32646 32796 32819 32886
32965 33020 33197 33206 33239 33269 33338 33454 33470 33494 32321 32117 32784
32831 32926 32581 31218 32992 33514 31117 33358 32674 31975 32539 32686 33712
31995 32718 31270 31804 33650 33433 32700 30167 33227 33757 33910 33796 33390
33098 33781 33995 33882 33516 33974 33709 33973 33992 31124 31619 33193 30033
31520 31876 30555 31335 30176 30472 33742 32741 32884 32887 30382 31599 32701
33432 32934 32761 32932 32540 32762 32827 32736 33041 32554 32583 33024 32978
32365 32496 32338 32449 32473 32917 32918 32514 32510 32222 32856 33059 32891
32877 33044 33049 33276 30412 30575 33300 31471 30993 31131 31363 33416 33261
33244 33230 33131 31810 31856 32042 33431 33195 33089 33162 33285 33060 33196
33101 33544 33070 31746 33283 33229 32143 33452 33517 33105 31367 33310 33724
33403 30834 33559 33587 33624 33652 30715 30315 33797 33774 33399 32772 32168
33032 31055 30695 33561 33672 32955 31976 31241 Material Number 8247888-- with
Serial Numbers: 31116 32673 32783 33143 31359 31775 32848 32968 Material Number
8253683-- with Serial Numbers: 40290 40311
RECALLING
FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Mountain
View, CA,
REASON Software error: Error
affects all Aspen customer systems using the PAL video standard configuration
and has a Perspective PC installed. This can lead to a measurement error under
this specific condition: On secondary capture images/clips stored from within
any Perspective advanced display option (specifically: 3D Surface Rendering, 3D
MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reconstruction or
FreeStyle extended imaging, FreeStyle compounding, or FreeStyle dynamic CDI
technology).
VOLUME OF PRODUCT IN COMMERCE 242
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Pulavac, Plus Wound Debridement System, Component Kit, Catalog #
00-5150-
420-00, 10 kits/package,
b) Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1
kit/package,
c) Pulsavac Plus
Wound Debridement System, Fan Spray Kit , Catalog
#00-5150-475-
00, 10 kits/package,
d) Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01;
1kit/package,
e) Pulsavac Plus
AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package,
f) Pulsavac Plus Wound Debridement System, Hip Kit,
Catalog #00-5150-482-00, 10
kits/package,
g) Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package,
h) Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1
kit/package,
i) Pulsavac Plus
Wound Debridement System, Shower Spray Kit, Catalog
#00-5150-
495-00, 10kits/package,
j) Pulsavac Plus Low Pressure Fan Spray Kit, Catalog
#00-5150-975-00, 10 kits/
package,
CODE
a) Lot Numbers: 60613025, 60617428,
60622532, 60626631, 60629996, 60633951,
60640534,
60650384, 60652419, 60656841, 60661592, 60661594, 60666491,
60666492, 60671448, 60671449, 60676102, 60693310,
60693311, 60693314,
60693315, 60693326, 60693327,
60694265, 60694266, 60698941, 60703269,
60709912,
60715481, 60723866, 60725488, 60733552, 60733553, 60737816,
60737817, 60739957, 60739958, 60744533, 60744534,
60750514, 60750515, and
60758733;
b) Lot Numbers:
60622533, 60642558, 60654878, 60656842, 60693312, and 60725489;
c) Lot
Numbers: 60607940, 60612145, 60612148, 60613026, 60613027, 60613028,
60613029, 60613030, 60617429, 60617430, 60617431,
60617432, 60617433,
60622534, 60622535, 60622536,
60622537, 60626632, 60626633, 60626634,
60626635,
60626636, 60629997, 60629998, 60629999, 60630001, 60630002,
60633952, 60633953, 60633954, 60633955, 60640536,
60640537, 60640538,
60640539, 60640540, 60642559,
60642560, 60642561, 60642562, 60642563,
60650385,
60650386, 60650387, 60650388, 60652362, 60652363, 60652364,
60652365, 60652367, 60652368, 60652369, 60652421,
60652422, 60652424,
60652425, 60652426, 60652427,
60652429, 60661596, 60661598, 60661601,
60661604,
60661609, 60661616, 60666494, 60666495, 60693316, 60693317,
60693318, 60693319, 60693328, 60693329, 60693331,
60693332, 60693333,
60693334, 60694267, 60694268,
60694269, 60694270, 60694271, 60694272,
60698942,
60698943, 60698944, 60698945, 60698946, 60698947, 60703274,
60703276, 60703289, 60703301, 60703303, 60708431,
60708432, 60708433,
60708435, 60708437, 60709913,
60709914, 60709915, 60709916, 60709918,
60709988,
60715482, 60715484, 60715485, 60715487, 60715488, 60715490,
60723867, 60723868, 60723869, 60723870, 60723873,
60723874, 60723875,
60725490, 60725491, 60725493,
60725494, 60725496, 60733554, 60733555,
60733556,
60733557, 60733558, 60737818, 60737819, 60737820, 60737821,
60739959, 60739960, 60739961, 60739962, 60739963,
60744536, 60744537,
60744538, 60744539, 60750517,
60750520, 60750523, 60750526, 60758734,
60758735,
60758736, 60758737, 60758738, 60758739, 60758740, 60768263,
60768268, 60768269 60768270, 60768271, 60768272,
60769241, 60769242,
60769243, 60769244, 60769245,
60778396, 60778397, 60778398, 60778399,
60782132,
60782133, 60782134, 60782135, 60782136, 60784396, 60784397,
60784398, 60784401, 60784403, 60788880, 60788881,
60788882, 60788883,
60788884, 60795133, 60795140,
60795141, 60795142, 60802487, 60802488,
60802489,
60802490, 60802491, 60802492, 60804280, 60804281, and 60804282;
d) Lot
Numbers: 60626637, 60652433, 60671457, 60693320, 60698948, 60708439,
60715492, and 60725499;
e) Lot Numbers: 60650389,
60693321, 60708442, 60778376, 60788853, and 60809433;
f) Lot Numbers:
60612157, 60612160, 60613031, 60613032, 60617434, 60617435,
60622538, 60626638, 60630003, 60630004, 60633956, 60633957, 60633958,
60640541, 60640542, 60642564, 60642565, 60642566,
60650390, 60650391,
60652435, 60656852, 60656853,
60656854, 60661621, 60661622, 60661623,
60666504,
60666506, 60693313, 60693322, 60693323, 60693336, 60693338,
60693340, 60694275, 60694276, 60694278, 60698949,
60703306, 60708444,
60709920, 60715493, 60723876,
60725500, 60733559, 60733560, 60737822,
60737823,
60739964, 60739965, 60744540, 60744542, 60750527, 60750528,
60758741, 60758742, 60768273, 60768274, 60769247,
60769248, 60778401,
60778402, 60782137, 60782138,
60784405 60784407, 60788885, 60788886, and
60795145;
g) Lot Numbers: 60613033, 60630005, 60650392, 60656855, 60666509,
60693324,
60694281, and 60703308;
h)
Lot #'s 60680331, 60708447, 60715494, 60733561, 60778403, 60795147,
60835632;
i) Lot Numbers: 60612164, 60613034, 60617436,
60622539, 60622540, 60626639,
60630007, 60633959,
60642567, 60650393, 60652438, 60652439, 60661624,
60693325, 60693342, 60694283, 60694285, 60698950, 60698951, 60703310,
60703312, 60708448, 60708449, 60708450, 60709922,
60723880, 60725501,
60733562, 60737824, 60739968,
60744543, and 60750529;
j) Lot Numbers: 60626640, 60666511,
60709924, 60734619, and 60778405
RECALLING
FIRM/MANUFACTURER Zimmer Orthopaedic Surgical Products,
Dover, OH,
REASON Sterility (package integrity)
compromised: The effect of a silicone stain produced during assembly operations
on the sterility barrier properties of the Tyvek lids has not been validated by
the firm.
VOLUME OF PRODUCT IN COMMERCE 84,644
kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog
Numbers:
5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and
T5C4441R, Made in U.S.A,
b)
HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers;
5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and
T5C8300R,
CODE
a) All serial numbers released prior to
09/21/07;
b) All serial numbers released prior to
08/23/07
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Baxter Healthcare Renal Div., Mc Gaw Park, IL,
Manufacturer: Baxter Healthcare Corporation, Largo, FL.
F
REASON Unrecorded Infusion:
If the system is powered down or a power failure occurs during a fill cycle, the
HomeChoice system may not record the last 1-4 pump strokes infused into the
patient when the power is restored. This situation may create a potential
unrecorded delivery of approximately 15-60 mL of fluid being infused into the
patient.
VOLUME OF PRODUCT IN COMMERCE 103,490
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT System 83 Plus Washer-Disinfector, Endoscope use, DOS based system,
CODE
All serial
numbers.
RECALLING FIRM/MANUFACTURER Custom Ultrasonics,
Inc., Ivyland, PA,
REASON Inadvertent selection of the “wash”
cycle.
VOLUME OF PRODUCT IN COMMERCE 3,190
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Icy Hot Heat Therapy, Air Activated Heat Patch, Back and Large Areas, UPC Code
0-41167-08330-7, Product Code 08330, 4.1" x 8.4" (10.5 cm
x 2.1 cm) each, 1 and 3
count patches,
b) Icy Hot Heat Therapy, Air Activated Heat Patch, Arm, Neck and
Leg and Small
Areas, UPC Code 0-41167-08335-2, Product
Code 08335, 3.9" x 5.3" (10cm x 13.5
cm) each, 1 and 4
count patches, 08;
c) Aspercreme, Pain Relieveing Creme
with Aloe, Maximum Strength Formula, Net Wt
3 oz (85g)
with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually
wrapped patch, 3.9" x 5.3" (10cm x 13.5cm),
CODE
a) and b) All Lots;
c) Only those
Aspercreme units that have the "bonus packs" containing any lot of the
Icy Hot Heat Therapy patches
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Chattem Inc.,
Chattanooga, TN,
Manufacturer: Mycoal Products Corp., Tochigi-City, Japan.
REASON
Skin irritation
and burns with product usage.
VOLUME OF PRODUCT IN
COMMERCE 2,164,800
units
DISTRIBUTION Nationwide and Internationally
WEEK ENDING MARCH 22
PRODUCT
a) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw
System, Screw Size (diameter x length) 8 x 35, Catalog
Number LG-PR0835,
b) Size 8 Pedicle Screws of the Allez
Spine Laguna Pedicle Screw System, Screw Size (diameter x
length) 8 x 40, Catalog Number LG-PR0840,
c) Size 8
Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845,
d) Size 8 Pedicle Screws of the Allez Spine Laguna
Pedicle Screw System, Screw Size (diameter x length) 8 x
50, Catalog Number LG-PR0850,
e) Size 8 Pedicle Screws
of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855,
f) Size 8 Pedicle Screws of the Allez Spine Laguna
Pedicle Screw System, Screw Size (diameter x length) 8 x
80, Catalog Number LG-PR0880,
CODE
a) Lot
Numbers:10294-1,10294-2,10294-3,10294-4 and 10294-5;
b) Lot Numbers:
10295-1,10295-2,10295-3,10295-4, and 10295-5;
c) Lot Numbers:
10296-1,10296-2,10296-3,10296-4, and 10296-5;
d) Lot Numbers:
10297-1,10297-2,10297-3,10297-4, and 10297-5;
e) Lot Numbers:
10298-1,10298-2,10298-3,10298-4, and 10298-5;
f) Lot Number:
10528
RECALLING FIRM/MANUFACTURER Allez Spine, LLC,
Irvine, CA,
REASON Screw Shank Failure;
separation of the screw shank portion from the pedicle head portion of the Size
8 Pedicle Screw, when torquing down the single piece locking nut during
implantation.
VOLUME OF PRODUCT IN COMMERCE 1, 578
units
DISTRIBUTION Nationwide
PRODUCT Abbott - CELL-DYN 1800 System with
CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01,
CODE
Serial Numbers: 20835AY 19307AY
21801AY 21741AY 21739AY 22240AY 21698AY 19423AY 19490AY 18890AY 18332AY 19797AY
18112AY 19202AY 19960AY 22233AY 21224AY 21232AY 21212AY 21207AY 21276AY 22202AY
18871AY 18607AY 21349AY 19484AY 22226AY 19895AY 19623AY 18207AY 19125AY 22131AY
21197AY 20412AY 19189AY 19320AY 21347AY 22017AY 21936AY 19725AY 21354AY 20060AY
18310AY 19338AY 21758AY 21957AY 22013AY 18105AY 18169AY 18730AY 19288AY 18268AY
19386AY 20072AY 18992AY 21087AY 19633AY 18448AY 18991AY 19754AY 18763AY 18408AY
18705AY 18549AY 21287AY 19160AY 18735AY 18731AY 18847AY 18738AY 19392AY 19594AY
18182AY 18930AY 18706AY 21749AY 18627AY 18204AY 19650AY 18187AY 18197AY 18422AY
18551AY 18959AY 18558AY 19834AY 19839AY 20746AY 18579AY 19287AY 19153AY 19154AY
19501AY 18287AY 18957AY 20188AY 18255AY 19073AY 20730AY 19621AY 18589AY 18641AY
18477AY 18054AY 20784AY 20839AY 19001AY 18397AY 20806AY 20807AY 20841AY 19222AY
19836AY 18934AY 18699AY 18253AY 19319AY 20080AY 18592AY 22213AY 19665AY 18273AY
22217AY 18106AY 18838AY 18512AY 18307AY 18042AY 18440AY 18507AY 18936AY 18526AY
18774AY 19123AY 19405AY 18240AY 18506AY 18335AY 20763AY 18190AY 21891AY 21152AY
19654AY 19012AY 18196AY 18302AY 18511AY 18877AY 18893AY 19015AY 19090AY 19452AY
18721AY 18853AY 18598AY 19401AY 19402AY 19471AY 18591AY 19395AY 18725AY 18983AY
22181AY 18988AY 19622AY 21396AY 19661AY 21377AY 21375AY 18710AY 20272AY 19693AY
18740AY 21003AY 18286AY 18183AY 19391AY 18575AY 18113AY 20193AY 19284AY 19054AY
21962AY 20416AY 18257AY 18236AY 18176AY 21963AY 18226AY 18184AY 18075AY 18101AY
18467AY 21992AY 18615AY 18792AY 21763AY 18516AY 19018AY 18529AY 19612AY 18921AY
18420AY 18291AY 19916AY 19626AY 19741AY 18686AY 19037AY 18981AY 20253AY 18767AY
21348AY 18382AY 19728AY 18403AY 20641AY 19215AY 19466AY 19628AY 18117AY 19528AY
18033AY 18230AY 18719AY 19667AY 18819AY 18689AY 18829AY 19036AY 21746AY 18008AY
20065AY 20095AY 19717AY 20785AY 22045AY 20787AY 18732AY 18788AY 18670AY 18334AY
20900AY 21296AY 20097AY 19028AY 18623AY 22027AY 18508AY 22047AY 18329AY 18377AY
18192AY 18172AY 21368AY 20911AY 19174AY 19703AY 19595AY 19611AY 21331AY 20187AY
21525AY 18316AY 19706AY 19117AY 18053AY 21378AY 19389AY 18491AY 20759AY 19698AY
19252AY 18469AY 18348AY 19774AY 19716AY 18637AY 18944AY 20109AY 18049AY 19731AY
19099AY 19332AY 19306AY 19629AY 18711AY 20744AY 20203AY 19590AY 18284AY 21359AY
20654AY 19543AY 18295AY 18666AY 18037AY 18035AY 18304AY 18271AY 20939AY 19905AY
19101AY 20034AY 22214AY 18544AY 19045AY 21278AY 21106AY 20003AY 18064AY 18044AY
18441AY 18672AY 19600AY 18412AY 19166AY 18749AY 18758AY 19750AY 18779AY 18793AY
20907AY 19233AY 19685AY 21186AY 18750AY 21337AY 20876AY 20874AY 18742AY 18744AY
18743AY 21150AY 18604AY 22095AY 20754AY 21358AY 18879AY 18449AY 19586AY 19312AY
21342AY 20018AY 19134AY 19014AY 18910AY 18426AY 18880AY 18185AY 21423AY 18395AY
21330AY 19300AY 21340AY 18305AY 18219AY 18040AY 19095AY 20743AY 19512AY 21735AY
19406AY 22002AY 22156AY 22172AY 18157AY 19457AY 18484AY 20335AY 18384AY 18168AY
18862AY 18380AY 18048AY 18166AY 18388AY 19156AY 18392AY 18356AY 19745AY 19410AY
20250AY 18256AY 18698AY 18625AY 20064AY 18707AY 18755AY 20779AY 18045AY 19175AY
20768AY 19813AY 18201AY 21190AY 22211AY 20032AY 18703AY 19474AY 21748AY 19598AY
18509AY 18818AY 19898AY 20107AY 18947AY 19686AY 20755AY 18167AY 18752AY 19486AY
20340AY 20341AY 19620AY 18695AY 18471AY 18161AY 20054AY 20652AY 18205AY 18682AY
18567AY 21853AY 19753AY 22164AY 18431AY 20940AY 22227AY 19707AY 18885AY 19185AY
19701AY 18520AY 18430AY 18514AY 18708AY 21379AY 19510AY 18447AY 18260AY 19644AY
18841AY 18571AY 18425AY 18626AY 20750AY 19159AY 19023AY 19161AY 19659AY 18924AY
18125AY 19426AY 19089AY 21204AY 18022AY 19587AY 19885AY 21115AY 21886AY 18308AY
21740AY 21981AY 22117AY 18211AY 19718AY 19221AY 18999AY 19920AY 19103AY 18810AY
20068AY 20073AY 20076AY 20057AY 20051AY 18134AY 20052AY 20078AY 18202AY 18023AY
18684AY 18177AY 18527AY 18252AY 21068AY 19124AY 19411AY 18562AY 19092AY 20384AY
18958AY 18635AY 22104AY 19422AY 18178AY 18242AY 18648AY 21972AY 18111AY 19766AY
19842AY 18654AY 18649AY 18123AY 20386AY 18194AY 19816AY 18998AY 18265AY 19071AY
19438AY 18386AY 18590AY 19453AY 19894AY 21946AY 21743AY 22229AY 18303AY 18843AY
18913AY 22239AY 18438AY 18919AY 18418AY 18107AY 18564AY 19939AY 18778AY 19854AY
18296AY 19393AY 19923AY 18424AY 20309AY 18114AY 21353AY 21365AY 22212AY 22241AY
21952AY 21926AY 19335AY 19513AY 20053AY 18153AY 18771AY 18360AY 18608AY 18034AY
18174AY 18381AY 20844AY 18918AY 19030AY 19645AY 18428AY 18299AY 18239AY 18870AY
18138AY 18796AY 18270AY 18126AY 22201AY 19196AY 18410AY 18692AY 18005AY 20777AY
19087AY 18995AY 20079AY 18517AY 19636AY 18565AY 20323AY 20901AY 18519AY 18228AY
21528AY 18873AY 21392AY 18867AY 19102AY 18633AY 18681AY 19596AY 18697AY 21293AY
18503AY 19106AY 21987AY 18881AY 18722AY 22210AY 18415AY 18537AY 19121AY 18306AY
20278AY 19279AY 19719AY 19843AY 18845AY 18218AY 19192AY 21706AY 21333AY 21336AY
19082AY 18815AY 20071AY 18704AY 20997AY 21290AY 21745AY 21199AY 21943AY 19585AY
18096AY 18324AY 19936AY 18680AY 19127AY 20734AY 19418AY 19056AY 18780AY 19080AY
18421AY 19646AY 18094AY 18450AY 21114AY 19773AY 20736AY 21383AY 18617AY 18876AY
21366AY 19442AY 18777AY 21877AY 18274AY 21284AY 19263AY 21882AY 21009AY 18411AY
19712AY 18496AY 22150AY 18130AY 19640AY 19086AY 19088AY 18132AY 20992AY 22191AY
19815AY 19216AY 21279AY 18759AY 18135AY 19967AY 18555AY 18466AY 22028AY 19165AY
19137AY 18691AY 18552AY 18074AY 18683AY 18046AY 20357AY 18030AY 18293AY 20173AY
21265AY 18602AY 18609AY 20040AY 18227AY 19008AY 18530AY 18267AY 21264AY 20216AY
18605AY 19062AY 22220AY 18687AY 18290AY 20208AY 19357AY 21145AY 18976AY 18827AY
18175AY 18990AY 20113AY 19624AY 20056AY 21143AY 18933AY 18003AY 19325AY 18146AY
21335AY 21125AY 19145AY 18492AY 18500AY 19172AY 21308AY 18997AY 18320AY 19072AY
19079AY 20349AY 20994AY 19409AY 19733AY 18926AY 18155AY 18399AY 18741AY 19740AY
18596AY 21560AY 21213AY 21397AY 21666AY 21985AY 20108AY 19699AY 21205AY 20106AY
18419AY 18109AY 22004AY 18018AY 19060AY 18982AY 19053AY 18432AY 18693AY 18060AY
19310AY 19132AY 19074AY 20256AY 18024AY 18646AY 21990AY 19200AY 20012AY 18726AY
18437AY 18235AY 19991AY 19425AY 18163AY 19220AY 18390AY 19637AY 19503AY 19647AY
22208AY 19993AY 18766AY 18642AY 18566AY 22133AY 21975AY 20808AY 18522AY 19544AY
18854AY 18878AY 19777AY 19445AY 20672AY 18468AY 19852AY 20659AY 19935AY 18674AY
18675AY 19592AY 19403AY 18765AY 18912AY 19760AY 19934AY 19999AY 21210AY 19758AY
20321AY 19100AY 20125AY 18524AY 19237AY 18632AY 18355AY 18824AY 18911AY 18769AY
18546AY 18041AY 19732AY 18523AY 18414AY 18950AY 18214AY 18800AY 18237AY 19919AY
19020AY 21211AY 19492AY 18181AY 19734AY 19736AY 19702AY 19126AY 18210AY 18821AY
18143AY 19264AY 18550AY 20663AY 18199AY 22183AY 20765AY 18668AY 21958AY 20274AY
18209AY 18860AY 19440AY 21927AY 19499AY 18213AY 19232AY 19104AY 20175AY 19470AY
20006AY 21839AY 20000AY 19521AY 19588AY 20224AY 18232AY 18811AY 19901AY 19833AY
18224AY 19107AY 18573AY 20761AY 19917AY 21549AY 19197AY 19238AY 22006AY 18043AY
19094AY 19954AY 21274AY 21708AY 18948AY 18259AY 18417AY 20235AY 19947AY 19437AY
18393AY 20081AY 19173AY 18188AY 20653AY 19000AY 18090AY 19496AY 22145AY 19404AY
18739AY 18754AY 19579AY 21928AY 20201AY 18715AY 19241AY 18855AY 18017AY 20668AY
20662AY 20669AY 20075AY 18076AY 21555AY 21835AY 19911AY 19721AY 19108AY 20424AY
18531AY 18521AY 21754AY 19964AY 19962AY 19961AY 21974AY 19897AY 21854AY 18916AY
18857AY 20099AY 19966AY 19972AY 19985AY 20026AY 20788AY 19697AY 19687AY 19708AY
19696AY 20330AY 21790AY 19272AY 20197AY 20035AY 22132AY 20206AY 18541AY 20356AY
20242AY 20764AY 20783AY 19658AY 19555AY 18311AY 19950AY 20437AY 20667AY 20651AY
21262AY 19414AY 18327AY 18353AY 21188AY 20083AY 18165AY 20902AY 20211AY 19081AY
19282AY 20851AY 19679AY 20741AY 20747AY 19609AY 18198AY 18775AY 18830AY 18545AY
20649AY 20773AY 20774AY 20103AY 20611AY 21104AY 18217AY 21198AY 22166AY 21146AY
21182AY 21183AY 21178AY 18909AY 18317AY 18923AY 20311AY 20647AY 19384AY 21847AY
20269AY 18004AY 21922AY 21848AY 21889AY 20903AY 21175AY 20027AY 20031AY 20039AY
19913AY 18429AY 18072AY 20082AY 21949AY 22129AY 21381AY 21116AY 20233AY 21394AY
21285AY 19352AY 21548AY 22174AY 21369AY 19063AY 18832AY 21712AY 18292AY 19005AY
18886AY 18179AY 21075AY 21703AY 21910AY 19061AY 18673AY 21676AY 21734AY 22046AY
21794AY 21846AY 21773AY 19505AY 21857AY 18283AY 18200AY 21793AY 19946AY 21948AY
19236AY 21969AY 22123AY 20007AY 20732AY 19957AY 21940AY 18756AY 21947AY 18762AY
18574AY 19762AY 18278AY 22215AY 21067AY 19003AY 21924AY 22022AY 21904AY 19227AY
18901AY 21944AY 20661AY 18223AY 20067AY 22048AY 22125AY 21984AY 21991AY 19971AY
22231AY 21726AY 22225AY 22146AY 22234AY 19545AY 18745AY 20623AY 22000AY 20655AY
21566AY 18398AY 22121AY 19509AY 19295AY 19502AY 18225AY 18110AY 20769AY 21753AY
22207AY 21148AY 18636AY 18050AY 21189AY 18139AY 21725AY 21913AY 21911AY 19642AY
21187AY 22189AY 18446AY 18319AY 22029AY 19230AY 18951AY 19729AY 18300AY 18315AY
21070AY 21154AY 21000AY 21765AY 18532AY 22248AY 21898AY 21986AY 18443AY 19385AY
19776AY 19727AY 19164AY 19421AY 19477AY 18093AY 18277AY 20753AY 18553AY 21373AY
21977AY 20923AY 21372AY 19318AY 19561AY 18644AY 20931AY 18288AY 21147AY 18786AY
18372AY 22107AY 18611AY 22237AY 20002AY 19424AY 20665AY 20666AY 18554AY 18770AY
19035AY 19285AY 18504AY 19710AY 18733AY 19400AY 19388AY 21918AY 18433AY 21956AY
21180AY 18389AY 19847AY 18028AY 18052AY 18027AY 18001AY 18011AY 18002AY 18016AY
18010AY 18006AY 20648AY 18015AY 18678AY 18047AY 18019AY 18029AY 18009AY 18020AY
18014AY 18012AY 18137AY 22170AY 18026AY 18039AY 18021AY 19536AY 18013AY 18063AY
19677AY 18133AY 18038AY 18025AY 18036AY 18031AY 18098AY 18056AY 18059AY 18055AY
18032AY 18058AY 18057AY 18121AY 18071AY 18078AY 18080AY 18776AY 18062AY 18136AY
18089AY 18103AY 18097AY 18095AY 18100AY 18099AY 18084AY 18085AY 18083AY 18077AY
18092AY 18104AY 19303AY 18081AY 18091AY 18119AY 18115AY 18108AY 18127AY 18131AY
18122AY 18118AY 18102AY 19198AY 18144AY 18140AY 18164AY 18150AY 19451AY 18141AY
18193AY 18148AY 18322AY 18152AY 18173AY 18162AY 18158AY 21184AY 18171AY 18191AY
18170AY 18195AY 18189AY 18186AY 19356AY 18203AY 18836AY 18208AY 18206AY 18238AY
18241AY 18254AY 18212AY 18269AY 18258AY 18337AY 18289AY 18285AY 18294AY 18264AY
18282AY 18297AY 18313AY 18312AY 18280AY 18331AY 18298AY 18379AY 18336AY 18333AY
18321AY 18309AY 18301AY 18374AY 18376AY 18383AY 18350AY 18387AY 18351AY 19887AY
18396AY 18391AY 18394AY 18314AY 18400AY 18318AY 18401AY 18378AY 18385AY 18439AY
18407AY 18406AY 18416AY 18409AY 18434AY 18462AY 18534AY 18357AY 18402AY 18436AY
18435AY 20775AY 18442AY 20252AY 18444AY 18404AY 18423AY 18445AY 18427AY 18405AY
18452AY 18413AY 18486AY 18470AY 18485AY 18483AY 18472AY 18465AY 18451AY 18655AY
18505AY 18479AY 18475AY 18515AY 18513AY 20059AY 18494AY 18510AY 18518AY 18528AY
20237AY 19069AY 18525AY 18568AY 19224AY 18533AY 18630AY 18538AY 18535AY 18547AY
18539AY 18536AY 18543AY 18542AY 18599AY 18540AY 18548AY 18556AY 18557AY 19943AY
18570AY 18624AY 18563AY 18572AY 18569AY 19171AY 18601AY 18600AY 18914AY 18634AY
18696AY 18595AY 18593AY 18613AY 18594AY 18606AY 18616AY 18652AY 20025AY 18618AY
20024AY 18628AY 18629AY 18657AY 18638AY 18728AY 18631AY 18639AY 18645AY 18650AY
18640AY 18651AY 18667AY 18647AY 18643AY 18679AY 19093AY 18653AY 18748AY 18671AY
18656AY 18702AY 18694AY 18669AY 18677AY 18685AY 18688AY 18709AY 18712AY 18713AY
18690AY 18720AY 18676AY 18700AY 20243AY 18734AY 18723AY 18747AY 18736AY 20234AY
21001AY 18789AY 18714AY 18753AY 18751AY 18737AY 19013AY 18941AY 18746AY 18757AY
18791AY 18761AY 18760AY 18764AY 18768AY 18773AY 18781AY 18795AY 18798AY 18797AY
21073AY 18802AY 18809AY 19350AY 18814AY 18834AY 18869AY 18931AY 18816AY 18822AY
18820AY 18823AY 18817AY 18828AY 18852AY 18825AY 18826AY 18831AY 18833AY 18835AY
18837AY 18839AY 18840AY 18863AY 18855AY 18868AY 18861AY 18858AY 18866AY 18994AY
19273AY 19522AY 18907AY 18875AY 19096AY 18865AY 18864AY 21341AY 18986AY 18859AY
18883AY 18897AY 18884AY 18889AY 18872AY 18882AY 18915AY 18949AY 18892AY 18906AY
18902AY 19339AY 18917AY 18888AY 18856AY 18922AY 18920AY 18929AY 18908AY 18935AY
22149AY 22153AY 19032AY 18928AY 18927AY 18932AY 18966AY 18962AY 18955AY 18961AY
18980AY 20770AY 18985AY 18979AY 18989AY 18984AY 18987AY 18993AY 19025AY 18996AY
19002AY 19004AY 19019AY 19024AY 19021AY 19026AY 19022AY 19031AY 19029AY 19033AY
19034AY 19048AY 19046AY 19067AY 19068AY 19047AY 19057AY 19058AY 19122AY 19193AY
19064AY 19070AY 19075AY 19076AY 19065AY 19077AY 19078AY 19085AY 19083AY 19118AY
19129AY 19091AY 19097AY 19098AY 19130AY 19105AY 19109AY 19136AY 19110AY 19111AY
19113AY 19116AY 19119AY 22003AY 19128AY 19155AY 19120AY 19605AY 21475AY 19131AY
19761AY 19458AY 19135AY 19133AY 19147AY 19146AY 19148AY 19167AY 19168AY 19162AY
19460AY 19163AY 19169AY 19170AY 19190AY 19184AY 19187AY 22101AY 19186AY 19188AY
19191AY 19194AY 19195AY 21120AY 19562AY 19203AY 19206AY 19218AY 19217AY 19219AY
19226AY 19225AY 19229AY 19223AY 19231AY 19235AY 19234AY 19242AY 19240AY 19239AY
19464AY 19243AY 19280AY 19278AY 19277AY 19276AY 19265AY 19283AY 19281AY 19286AY
20418AY 19294AY 19289AY 19293AY 19292AY 19304AY 19309AY 19305AY 19443AY 19308AY
19329AY 19330AY 19314AY 19311AY 19326AY 19323AY 19313AY 19324AY 19317AY 19355AY
19321AY 19328AY 19333AY 19331AY 19334AY 19336AY 19343AY 19347AY 19348AY 19340AY
19399AY 19322AY 19316AY 19433AY 19351AY 19345AY 19354AY 19358AY 19353AY 19435AY
19419AY 19390AY 19369AY 19382AY 19346AY 19722AY 19407AY 19408AY 19413AY 19415AY
19416AY 19417AY 19432AY 19431AY 19430AY 19434AY 19436AY 19444AY 19439AY 19473AY
19441AY 19463AY 19462AY 19454AY 19450AY 19455AY 19461AY 19456AY 19459AY 19475AY
19465AY 19472AY 19489AY 19476AY 19485AY 19487AY 19488AY 19494AY 19497AY 19495AY
19493AY 19498AY 19511AY 19500AY 19504AY 19517AY 21919AY 19508AY 19603AY 19601AY
19604AY 19593AY 19638AY 21850AY 19516AY 19606AY 19599AY 19617AY 19597AY 19591AY
19607AY 19608AY 19660AY 19618AY 19627AY 19632AY 19610AY 19641AY 19630AY 19639AY
19625AY 19643AY 19602AY 19635AY 19527AY 19648AY 19634AY 19515AY 19538AY 19662AY
19540AY 19663AY 19652AY 19666AY 19529AY 19683AY 19655AY 19676AY 19524AY 19542AY
19664AY 19519AY 19560AY 19680AY 19668AY 19714AY 19649AY 19671AY 19651AY 19723AY
19694AY 19657AY 19656AY 19682AY 19673AY 19700AY 19739AY 19684AY 22031AY 19695AY
19705AY 19720AY 19775AY 19669AY 19724AY 19704AY 19709AY 19711AY 19730AY 19715AY
19713AY 19737AY 19726AY 19531AY 19520AY 19743AY 19525AY 19738AY 19735AY 19746AY
19744AY 19742AY 19526AY 19778AY 19551AY 21380AY 19535AY 19784AY 19577AY 22219AY
19903AY 19580AY 19790AY 19549AY 19996AY 19785AY 19566AY 19581AY 20270AY 19533AY
19564AY 19672AY 19756AY 19755AY 19850AY 19763AY 19749AY 19752AY 20350AY 19810AY
19764AY 19751AY 19757AY 19772AY 19765AY 19798AY 19779AY 19809AY 19811AY 19812AY
19817AY 19818AY 19819AY 19759AY 19820AY 19837AY 19838AY 21733AY 19857AY 19856AY
19855AY 20208AY 19891AY 19889AY 19888AY 19896AY 19892AY 19890AY 19902AY 19893AY
19899AY 20004AY 19906AY 19900AY 19969AY 19905AY 19918AY 19907AY 19908AY 19921AY
19928AY 19922AY 19997AY 21738AY 19931AY 19932AY 19959AY 19951AY 19963AY 19970AY
19968AY 19965AY 20016AY 19973AY 19986AY 19981AY 19977AY 19990AY 19992AY 19995AY
19998AY 19994AY 20005AY 20043AY 20008AY 20015AY 20020AY 20030AY 20042AY 20050AY
20033AY 20041AY 20048AY 20061AY 20049AY 20077AY 20184AY 20069AY 20261AY 20045AY
20062AY 20090AY 20179AY 20181AY 20339AY 20202AY 20257AY 20245AY 20333AY 20204AY
20207AY 20213AY 20240AY 20205AY 20229AY 20214AY 20232AY 20249AY 20286AY 20283AY
20332AY 20334AY 20104AY 20360AY 20795AY 20364AY 20105AY 20273AY 20228AY 20277AY
20251AY 20111AY 20383AY 20308AY 20857AY 20382AY 20413AY 20422AY 20425AY 20444AY
20436AY 20368AY 20369AY 20419AY 20608AY 20614AY 20656AY 20613AY 20760AY 20609AY
20610AY 20640AY 20646AY 20626AY 20650AY 20733AY 20637AY 21181AY 20644AY 20645AY
20660AY 20658AY 20664AY 20914AY 20684AY 20906AY 20686AY 20683AY 20752AY 20731AY
20312AY 20756AY 20840AY 20910AY 20729AY 20738AY 20312AY 20737AY 21384AY 21078AY
20740AY 20745AY 21191AY 20751AY 20748AY 20749AY 20766AY 20767AY 20790AY 21129AY
20804AY 20836AY 20789AY 20786AY 20796AY 21360AY 21122AY 20762AY 20909AY 20780AY
21920AY 21764AY 20915AY 20778AY 20880AY 20776AY 20908AY 20905AY 21280AY 20912AY
20932AY 20995AY 20913AY 21072AY 21014AY 21076AY 21339AY 21071AY 21069AY 21086AY
21113AY 21117AY 21123AY 21066AY 21107AY 20739AY 21119AY 21121AY 21124AY 21105AY
21127AY 21132AY 21126AY 21291AY 21118AY 21131AY 21142AY 21362AY 21171AY 21721AY
21170AY 21149AY 21172AY 21173AY 21153AY 21218AY 21155AY 21174AY 21162AY 21193AY
21196AY 21179AY 21200AY 21201AY 21185AY 21202AY 21192AY 21203AY 21273AY 21283AY
21818AY 21361AY 21705AY 21281AY 21277AY 21393AY 21286AY 21327AY 21112AY 21282AY
21289AY 21292AY 21307AY 21300AY 21301AY 21304AY 21297AY 21305AY 21288AY 21302AY
21303AY 21294AY 21295AY 21299AY 21298AY 21306AY 21309AY 21310AY 21271AY 22110AY
21329AY 21674AY 21328AY 21351AY 21344AY 21350AY 21356AY 21357AY 21343AY 21363AY
21346AY 21370AY 21374AY 21382AY 21352AY 21334AY 21386AY 21338AY 21364AY 21355AY
21345AY 21376AY 21367AY 21371AY 21385AY 21387AY 21390AY 21388AY 21558AY 21395AY
21422AY 21389AY 21406AY 22005AY 21479AY 21531AY 21533AY 21532AY 21667AY 21700AY
21701AY 21556AY 21555AY 21561AY 21557AY 21687AY 21675AY 21688AY 21699AY 21710AY
21707AY 21704AY 21726AY 22155AY 21725AY 21856AY 21729AY 21742AY 21702AY 21752AY
21709AY 21737AY 21744AY 21750AY 21751AY 21747AY 21755AY 21878AY 21757AY 21756AY
21791AY 21762AY 21761AY 21760AY 21732AY 21730AY 21766AY 21759AY 21736AY 21769AY
21819AY 22204AY 22230AY 21800AY 21789AY 21799AY 21822AY 21802AY 21809AY 21832AY
21833AY 21838AY 21902AY 22179AY 21831AY 21841AY 21840AY 21834AY 21827AY 21849AY
21869AY 21855AY 21851AY 21852AY 21860AY 21932AY 21876AY 21883AY 21881AY 21935AY
21899AY 21929AY 21880AY 21903AY 21896AY 21893AY 21884AY 21925AY 21888AY 21961AY
21965AY 21892AY 21895AY 21890AY 21897AY 21923AY 21964AY 21901AY 21908AY 21942AY
21934AY 22205AY 21950AY 21907AY 21931AY 21939AY 21930AY 22039AY 22030AY 21941AY
21955AY 21960AY 22025AY 22026AY 22033AY 22037AY 22015AY 21973AY 22032AY 22041AY
22065AY 22052AY 21983AY 21993AY 22053AY 22054AY 21995AY 22147AY 21982AY 21989AY
21988AY 21994AY 21979AY 21998AY 22120AY 21999AY 22001AY 22102AY 22116AY 22008AY
22109AY 22016AY 22050AY 22098AY 22096AY 22105AY 22099AY 22100AY 22103AY 22114AY
22108AY 22106AY 22111AY 22115AY 22113AY 22112AY 22118AY 22119AY 22222AY 22126AY
22124AY 22130AY 22154AY 22169AY 22163AY 22158AY 22159AY 22160AY 22165AY 22171AY
22176AY 22188AY 22192AY 22206AY 22216AY 22218AY 22221AY 22223AY 22224AY 22236AY
22228AY 22232AY 22209AY 18061AY 18067AY 18070AY 18243AY 18244AY 18245AY 18246AY
18247AY 18248AY 18249AY 18250AY 18251AY 18272AY 18275AY 18276AY 18279AY 18281AY
18352AY 18358AY 18359AY 18361AY 18362AY 18363AY 18364AY 18365AY 18366AY 18367AY
18368AY 18369AY 18370AY 18371AY 18373AY 18375AY 18658AY 18659AY 18660AY 18661AY
18662AY 18663AY 18664AY 18665AY 19349AY 19554AY 19568AY 19576AY 19814AY 20070AY
20074AY 20098AY 20223AY 20331AY 20336AY 20338AY 21063AY 21064AY 21945AY 21971AY
21978AY 22161AY 22162AY 19301AY 19302AY 19653AY 19929AY 20771AY 19491AY 20112AY
20742AY 19084AY 19149AY 19150AY 19151AY 19152AY 19394AY 19396AY 19397AY 19398AY
19874AY 19875AY 20046AY 20047AY 20055AY 20058AY 20063AY 20066AY 20088AY 20091AY
20189AY 20190AY 20191AY 20192AY 20244AY 20337AY 20359AY 20361AY 20362AY 20363AY
20377AY 20657AY 21077AY 21082AY 21083AY 21084AY 21692AY 21779AY 21780AY 21781AY
21782AY 21787AY 21900AY 22127AY 22128AY 19266AY 19290AY 19291AY 19420AY 19747AY
19748AY 19924AY 19925AY 19926AY 19927AY 20037AY 20038AY 20039AY 20324AY 21206AY
21324AY 21815AY 21816AY 21820AY 22036AY 22097AY 19327AY 19337AY 19341AY 19342AY
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21970AY 21976AY 21980AY 22007AY 22009AY 22011AY 22014AY 22018AY 22019AY 22020AY
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19783AY 19786AY 19787AY 19788AY 19789AY 19791AY 19792AY 19793AY 19795AY 19796AY
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21623AY 21624AY 21625AY 21626AY 21628AY 21629AY 21630AY 21631AY 21632AY 21633AY
21634AY 21635AY 21636AY 21637AY 21638AY 21639AY 21640AY 21641AY 21642AY 21643AY
21644AY 21645AY 21646AY 21647AY 21648AY 21649AY 21650AY 21651AY 21652AY 21653AY
21654AY 21655AY 21656AY 21657AY 21658AY 21659AY 21660AY 21661AY 21662AY 21663AY
21664AY 21665AY 22010AY 22012AY 22024AY 22034AY 22035AY 22040AY 22157AY 22175AY
22185AY 22186AY 22187AY 18942AY 18943AY 18945AY 18946AY 19681AY 21141AY 21144AY
18559AY 18560AY 18561AY 18804AY 18805AY 18960AY 19530AY 19537AY 19541AY 19583AY
19631AY 19674AY 19782AY 19871AY 19933AY 19958AY 20255AY 21080AY 21081AY 21085AY
21559AY 21694AY 21824AY 21875AY 21885AY 21887AY 19059AY 19066AY 19989AY 22043AY
22044AY 22122AY 19613AY 19614AY 19615AY 19616AY 19619AY 19428AY 19429AY 19483AY
19506AY 20110AY 20161AY 21844AY 21845AY
RECALLING
FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA,
REASON Incorrect Results: Hemoglobin results in donor
samples assayed on the CELL-DYN 1800 System vary more than expected across the
range of claimed operating temperatures of 18 degrees Celcius to 30 degrees
Celcius.
VOLUME OF PRODUCT IN COMMERCE 4,224
Systems
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Biomet RINGLOC + Instrumentation Impactor Plate, Size 20;
REF/Part #: 31-400620,
b) Biomet
RINGLOC + Instrumentation Impactor Plate, Size 21; REF/Part #:
31-400621,
c) Biomet RINGLOC +
Instrumentation Impactor Plate, Size 22; REF/Part #: 31-400622,
d) Biomet RINGLOC +
Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623,
e) Biomet RINGLOC +
Instrumentation Impactor Plate, Size 26; REF/Part#:
31-400626,
f) Biomet RINGLOC +
Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628,
CODE
a) Lot
Number: 038670;
b) Lot Number: 038680;
c) Lot Number: 038690;
d) Lot
Number: 038700;
e) Lot Number: 038710;
f) Lot Number:
038730;
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw,
IN,
REASON The instrument will not lock onto the
impactor handle; the device was distributed without assembly of the Bal Seal
component.
VOLUME OF PRODUCT IN COMMERCE 141
units
DISTRIBUTION Nationwide, Germany, The Netherlands,
Sweden and The United
Kingdom
PRODUCT
a) GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600,
b) GE Healthcare, Mobile
Fluoroscopy X-Ray System, OEC, Model 7700,
CODE
a) All serial numbers;
b) All Serial
Numbers beginning with 79-, which is followed by 2006, 2008, 2009, 2011, 2013,
2014, 2015, 2016, 2018, C0513-C, C0878, C0986, C1016, C1017, C1021, C1037,
C1038, C1043, C1044, C1052, C1053, C1054, C1055, C1056, C1060, C1061, C1062,
C1063, C1065, C1068, C1069, C1070, C1080, C1082, C1083, C1087, C1088, C1091,
C1155, C1162, C1165, C1170, C1176, C1180, C1181, C1184, C1187, C1188, C1189,
C1190-M, C1192, C1193, C1195, C1196, C1197, C1198, C1199, C1201, C1203, C1204,
C1207, C1208, C1209, C1210, C1212, C1213, C1214, C1216, C1219, C1236, C1238,
C1241, C1246, C1248, C1249, C1254, C1255, C1259, C1260, C1263, C1265, C1266,
C1269, C1271, C1272-RC, C1275, C1279, C1281, C1306, C1427, C1434, C1437, C144,
C1446, C1461, C1476, C1501, C1507-M, C1511, C1529, C153, C1557, C1571, C1578,
C158-RC, C1697, C1703, C1716, C1721, C1835, C1841, C1883, C189, C1903, C193,
C2058, C2061, C3005, C3050, C3052a, C3053, C3055C3056, C3057, C3058, C3059,
C3062, C3063, C3073, C3074, C3075, C3076, C3077, C3078, C3081, C3082, C3084,
C3094, C3112, C3114, C3124, C3126, C3130, C3138, C3142, C3144, C3279, C601,
C604, C605, C606-RC, C608, C609, C610, C613, C614, C616, C617, C618, C619, C620,
C625, C626, C631, C633, C636, C640, C641, C647, C647-RC, C648, C651, C656, C666,
C667, C669, C675, C676, C679, C680, C681, C682, C683, C684, C685, C689, C691,
C692, C693, C694, C698, C699, C7084, C727, C744, C753, C774, C787, C800, C807,
C808, C819, C855, C860, C863, C870, C873-RC, C878, C883-M, C886, C895-M, C904,
C905, C906, C907-M, C911, C913, C916, C917-M, C922, C923-M, C926, C927, C928,
C930, C933, C937, C938, C942, C943, C948, C949, C953-C, C953-M, C954, C955,
C957-M, C970-M, C976, C982, C986, C987, S0607, S0970M, S1000, S1001, S1020,
S1024, S1058, S1059, S1071, S1077, S1078, S1098, S1108, S1145, S1169-M, S1221-M,
S1287, S1322, S1497, S1545, S1581, S1686, S271, S300, S418, S605, S615, S621,
S622, S627, S628, S629, S630, S632, S634, S635, S637, S638, S639, S643, S644,
S645, S646, S649, S649a, S650, S652, S653, S655, S657, S658, S659, S660, S661,
S662, S663, S664, S668, S670, S671, S672, S674, S676, S677, S678, S686, S687,
S696, S699, S700, S705, S732, S738, S746, S748, S766, S773, S779S766-RC, S791,
S792, S798, S805-RC, S806, S814, S815, S816, S817, S818, S823, S824, S825, S829,
S831, S838, S843, S845, S846, S846-M, S853, S854, S858, S859, S862, S863,
S865-M, S867, S869, S874, S875, S879, S882, S884, S885-M, S891, S896, S900,
S901, S901-M, S959, S964, S965, S969, S981, S988, S992, and S997
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems,
Inc., Salt Lake City, UT
REASON Unnecessary operator
exposure; X-ray machine may allow unwanted x-ray exposure to the
operator.
VOLUME OF PRODUCT IN COMMERCE 709
systems
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Bayer Contour TS blood glucose monitoring system with 10 blood
glucose test strips enclosed; Products 1802 and 1802N
(U.S.), 1810 (Korea), 1811 (India, Korea and Mexico) and
1825 (Mexico),
b) Bayer Contour TS blood glucose test
strips packaged in packs of 10, 25, 50 and 100 strips;
U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, 1833 and 1837 (India); 1823 and 1825 (Mexico),
CODE
a) Test strip lots: WK7DD3E31A,
WK7DD3E31B, WK7DD3E31D, WK7DD3E51C, WK7DD3E51D,
WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A,
WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F, WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A,
WK7FD3E31C, WK7FD3E31D, WK7FD3E31E, WK7FD3E31F,
WK7FD3E31H, WK7FD3E32C, WK7FD3E34A, WK7FD3E34B,
WK7FD3E51A, WK7FD3E51B, WK7GD3E01A, WK7GD3E02A,
WK7GD3E05A, WK7GD3E51A and WK7GD3E51B;
b) Test strip lots: WK7DD3E31A,
WK7DD3E31B, WK7DD3E31D, WK7DD3E51C, WK7DD3E51D,
WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A,
WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F,
WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A,
WK7FD3E31C, WK7FD3E31D, WK7FD3E31E, WK7FD3E31F,
WK7FD3E31H, WK7FD3E32C, WK7FD3E34A, WK7FD3E34B,
WK7FD3E51A, WK7FD3E51B, WK7GD3E01A, WK7GD3E02A,
WK7GD3E05A, WK7GD3E51A and WK7GD3E51B
RECALLING
FIRM/MANUFACTURER Bayer Healthcare LLC, Mishawaka, IN
REASON Inaccurate Test Strips Results: Results in blood
glucose readings with a positive bias are outside the product specifications.
Patient test results may demonstrative results 5 percent to 17 percent
higher.
VOLUME OF PRODUCT IN COMMERCE 97,000 bottles of
test strips
DISTRIBUTION Nationwide and
Internationally
PRODUCT Linemaster Wireless Footswitch Accessory, Model
SP-9970214-005112010 and Model SP-9970214-005112232, CODE All units
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Sound Surgical Technologies,
LLC,
Louisville, CO, Manufacturer:
Linemaster Switch Corporation, Woodstock, CT. REASON Failure to shut-off: Surgical equipment,
activated by a wireless foot switch with VASER system, may remain powered on
when switch is no longer depressed.
VOLUME OF PRODUCT IN
COMMERCE 127
switches
DISTRIBUTION Nationwide, Colombia, Costa Rica
and Switzerland
PRODUCT
a) Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF
306-400, Qty 6; For use with the Stryker PCD Precision
System and ACM Delivery System, Rx only, sterile,
b) Stryker VertePort, 10 G Cement
Cannula, REF 306-410, Qty
18; For use with the Stryker PCD Precision System and ACM
Delivery System, Rx only, sterile,
c) Stryker VertePort, 10 G Access Canula (short), REF 306-430,
Qty 6; For use with the Stryker PCD Precision System and
ACM Delivery System, Rx only, sterile,
d) Stryker VertePort , 11 G Cement
Cannula, REF 306-510 , Qty
18; For use with the Stryker PCD Precision System and ACM
Delivery System, Rx only, sterile,
CODE
a) All Lots- BCWD and
BENC;
b) All
Lots-BDB4, BDMA, BF4C, BF80, BFA4, BMWH and BQ5L;
c) All Lots-BCXE and BENB;
d) All Lots-BB43, BDL5, BE0M, BE1D, BE77, BF4K,
BMWJ, BNW8, BNW9 and
BQ5W
RECALLING
FIRM/MANUFACTURER Stryker Instruments Division of Stryker
Corporation, Portage, MI,
REASON Mis-labeling; The instructions
for use include a use for which the device is not intended. (Device not approved
to capture a bone biopsy).
VOLUME OF PRODUCT IN
COMMERCE 953
boxes
DISTRIBUTION Nationwide
PRODUCT
a) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number:
5999LV1, Exu-Dry Large Burn Vest,
b) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing,
Product Number: 5999LJ1, Exu-Dry Large Burn Jacket,
c) Smith & Nephew, Inc.,
Exu-Dry Wound Burn
Dressing, Product Number: 5999LPL, Exu-Dry Leg Dressing,
d) Smith & Nephew, Inc.,
Exu-Dry Wound Burn
Dressing, Product Number: 5999L72, Exu-Dry Sheet 36"x72"
Non-Permeable,
e) Smith & Nephew, Inc., Exu-Dry
Wound Burn Dressing, Product Number: 5999L73, Exu-Dry
Sheet 36"x72" Non-Permeable with Straps,
f) Smith &
Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L74, Exu-Dry Sheet 36"x72" Permeable with Straps Quilted,
g) Smith & Nephew, Inc.,
Exu-Dry Wound Burn
Dressing, Product Number: 5999MJ1, Exu-Dry Medium Burn
Jacket,
h) Smith & Nephew, Inc., Exu-Dry Wound Burn
Dressing, Product Number: 5999M36, Exu-Dry Pad 24"x36"
Non-Permeable Heavy Absorbency,
i) Smith & Nephew,
Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999BP1, Exu-Dry Adult Buttocks Dressing,
j) Smith & Nephew, Inc.,
Exu-Dry Wound Burn Dressing,
Product Number: 5999028, Exu-Dry Dressing, 20" x 28",
k) Smith & Nephew, Inc.,
Exu-Dry Wound Burn
Dressing, Product Number: 5999018, Exu-Dry Dressing, 15"
x 18",
l) Smith & Nephew, Inc., Exu-Dry Wound Burn
Dressing, Product Number: 5999024, Exu-Dry Dressing, 15"
x 24",
m) Smith & Nephew, Inc., Exu-Dry Wound Burn
Dressing, Product Number: 5999M09, Exu-Dry Dressing, 15"
x 9",
n) Smith & Nephew, Inc., Exu-Dry Wound Burn
Dressing, Product Number: 5999M18, Exu-Dry Dressing, 15"
x 18",
o) Smith & Nephew, Inc., Exu-Dry Wound Burn
Dressing, Product Number: 5999M24, Exu-Dry Dressing, 15"
x 24",
p) Smith & Nephew, Inc., Exu-Dry Wound Burn
Dressing, Product Number: 5999M28, Exu-Dry Dressing, 15"
x 28",
q) Smith & Nephew, Inc., Exu-Dry Wound Burn
Dressing, Product Number: 5999M37, Exu-Dry Pad 24"x36"
Non-Permeable Medium Absorbency,
r) Smith & Nephew,
Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M38, Exu-Dry Pad 24"x36" , Permeable Medium Absorbency,
s) Smith & Nephew, Inc.,
Exu-Dry Wound Burn Dressing,
Product Number: 5999SJ1, Exu-Dry Small Burn Jacket,
CODE
a) Lot Numbers: 70720, and
70704;
b) Lot Numbers: 70612, and 70702;
c) Lot Numbers:070613, 070512,
and 070418;
d) Lot Numbers: 70702, 70609, 70508, and 70424;
e) Lot
Numbers: 70703, 70610, and 70509;
f) Lot Numbers: 70718, 70611, and
70510;
g) Lot Numbers: 70709, and 70523;
h) Lot Numbers: 70708, 70620, and
70520;
i) Lot Numbers: 70607, 70506, and 70629;
j) Lot Number;
70628;
k) Lot Number; 70501;
l) Lot Number; 70502;
m) Lot Number;
70516;
n) Lot Number; 70517;
o) Lot Number: 70518;
p) Lot Numbers;
70707, 70723, and 70805;
q) Lot Numbers; 70414, 70521, 70621, and
70708;
r) Lot Numbers; 70522, and 70622;
s) Lot Number
70710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith
and Nephew, Inc., Wound Management Division, Largo, FL,
Manufacturer: Winer Industries
(Shenzhen) Co., Ltd., Shenzhen,
China.
REASON Sterility (package integrity) compromised:
Distribution of product that did not meet specifications, open
seals.
VOLUME OF PRODUCT IN COMMERCE 12,840 individual
dressings
DISTRIBUTION Nationwide and Internationally
PRODUCT Exactech
12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component,
CODE
Lot Number: 474042
RECALLING
FIRM/MANUFACTURER Exactech, Inc. Gainesville, FL,
REASON
Mislabeled: A ten piece lot of 140-32-03,
12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec
were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads,
28mm.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION NY, OH and TN
Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps
Medtronic Neuromodulation Implantable Infusion Pumps:
These devices administer drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories.
The company updated the labeling for the devices to include current patient management and treatment recommendations. The company also received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. For more detailed information, please see the link below to the company’s press release.
Patients or customers may contact Medtronic Neuromodulation at 1-800-707-0933 from Monday - Friday, 7:00 a.m. – 6:00 p.m. (Central Standard Time) or by emailing the company at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/linkwarning/linkwarning.cfm?link=http%3A%2F%2Fwww%2Emedtronic%2Ecom%2Fcorporate%2Fcontact%2Ejsp
WEEK ENDING MARCH 29
PRODUCT
a)
Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by
ethylene oxide gas. 10 mL pump with reservoir valve. The
implantable Medtronic SynchroMed EL Programmable Pump is
part of the SynchroMed EL Infusion System designed to
contain and administer parenteral drugs to a specific site. The implantable
components of the SynchroMed EL Infusion System include
the pump with or without a side catheter access port,
catheters, and catheter accessories,
b) Medtronic
SynchroMed EL Implantable Infusion Pump, model 8626-18. The contents of the inner package have been sterilized by
ethylene oxide gas. 18 mL pump with reservoir valve. The
implantable Medtronic SynchroMed EL Programmable Pump is
part of the SynchroMed EL Infusion System designed to
contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include
the pump with or without a side catheter access port,
catheters, and catheter accessories.
c) Medtronic SynchroMed EL Implantable Infusion Pump, model
8626L-10. The contents of the inner package have been
sterilized by ethylene oxide gas. 10 mL pump with
reservoir valve and suture loops. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL
Infusion System designed to contain and administer parenteral
drugs to a specific site. The implantable components of the
SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter
accessories.
d) Medtronic SynchroMed EL Implantable
Infusion Pump, model 8626L-18. The contents of the inner
package have been sterilized by ethylene oxide gas. 18 mL
pump with reservoir valve and suture loops. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL
Infusion System designed to contain and administer
parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump
with or without a side catheter access port, catheters,
and catheter accessories,
e) Medtronic SynchroMed EL
Implantable Infusion Pump, model 8627-10. The contents of
the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and screened side catheter access port.
The implantable Medtronic SynchroMed EL Programmable Pump
is part of the SynchroMed EL Infusion System
designed to
contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include
the pump with or without a side catheter access port,
catheters, and catheter accessories,
f) Medtronic
SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents of the inner package have been sterilized by ethylene
oxide gas. 18 mL pump with reservoir valve and screened
side catheter access port. The implantable Medtronic
SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System
designed to contain and administer parenteral drugs to a
specific site. The implantable components of the
SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter
accessories,
g) Medtronic SynchroMed EL Implantable
Infusion Pump, model 8627L-10. The contents of the inner
package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve, screened side catheter access port
and suture loops. The implantable Medtronic SynchroMed EL
Programmable Pump is part of the SynchroMed EL Infusion
System designed to contain and administer parenteral drugs
to a specific site. The implantable components of the
SynchroMed EL Infusion System include the pump with or
without a side catheter access port, catheters, and
catheter accessories,
h) Medtronic SynchroMed EL
Implantable Infusion Pump, model 8627L-18. The contents
of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side catheter access port
and suture loops. The implantable Medtronic SynchroMed EL
Programmable Pump is part of the SynchroMed EL Infusion
System designed to contain and administer parenteral drugs
to a specific site. The implantable components of the
SynchroMed EL Infusion System include the pump with or
without a side catheter access port, catheters, and
catheter accessories,
i) Medtronic SynchroMed II
Programmable Pump, model 8637-20. The contents of the
inner package have been sterilized by ethylene oxide gas. 20 mL reservoir. The implantable Medtronic SynchroMed II Programmable Pump is
part of the SynchroMed II Infusion System designed to
contain and administer prescribed drugs to a specific
site. The implantable components of the SynchroMed II Infusion System include
the pump, catheter, and catheter accessories,
j) Medtronic SynchroMed II Programmable Pump, model 8637-40.
The contents of the inner package have been sterilized by
ethylene oxide gas. 40 mL reservoir. The implantable
Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer
prescribed drugs to a specific
site. The implantable
components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories,
k) Medtronic IsoMed Implantable Constant-Flow Infusion Pump,
model 8472-20. The contents of the inner package have
been sterilized by ethylene oxide gas. Reservoir size: 20 mL. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is
part of the IsoMed Constant-Flow Infusion System designed
to contain and administer parenteral drugs to a specific
site. The components of the IsoMed Constant-Flow Infusion
System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port
kit. IsoMed pumps are
implantable devices that store and
dispense drugs according to a constant flow rate set
during the manufacturing process,
l) Medtronic IsoMed
Implantable Constant-Flow Infusion Pump, model 8472-35. The contents of the inner package have been sterilized by
ethylene oxide gas. Reservoir size: 35 mL. The
implantable Medtronic IsoMed Constant-Flow Infusion Pump is
part of the IsoMed Constant-Flow Infusion System designed
to contain and administer parenteral drugs to a specific
site. The components of the IsoMed Constant-Flow Infusion
System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port
kit. IsoMed pumps are
implantable devices that store and
dispense drugs according to a constant flow rate set
during the manufacturing process,
m) Medtronic IsoMed
Implantable Constant-Flow Infusion Pump, model 8472-60. The contents of the inner package have been sterilized by
ethylene oxide gas. Reservoir size: 60 mL. The
implantable Medtronic IsoMed Constant-Flow Infusion Pump is
part of the IsoMed Constant-Flow Infusion System designed
to contain and administer parenteral drugs to a specific
site. The components of the IsoMed Constant-Flow Infusion
System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port
kit. IsoMed pumps are
implantable devices that store and
dispense drugs according to a constant flow rate set
during the manufacturing process,
CODE All serial numbers
RECALLING
FIRM/MANUFACTURER Medtronic Neuromodulation, Minneapolis, MN,
REASON
Device/Drug Interaction - Implantable
Infusion Pump with the use of opioids, baclofen, pharmacy compounded baclofen
and other drugs, as well as with other pharmacological admixtures, will cause
the patient to develop inflammatory mass presented as a chronic inflammatory or
glaucomatous mass at or near the distal tip of the intrathecal catheter by its
use or exposure to cause serious adverse health consequences including
death.
VOLUME OF PRODUCT IN COMMERCE 102,792
units
DISTRIBUTION Nationwide and Internationally
PRODUCT GreenLight HPS System, Surgical Laser System and Accessories. Part
Numbers 0010-0070 and 0010-0075 (international units),
CODE
Serial Numbers (All starting with
HPS2): 125, 167, 057, 067, 072, 106, 114, 120, 149, 193, 186, 161, 037, 039,
040, 044, 050, 088, 185, 190, 197, 035, 160, 208, 046, 076, 102, 074, 108, 121,
141, 173, 178, 089, 069, 030, 155, 172, 174, 148, 042, 164, 098, 175, 100, 169,
196, 056, 071, 132, 165, 036, 201, 033, 123, 065, 206, 170, 179, 095, 177, 073,
194, 086, 064, 122, 133, 049, 060, 078, 112, 150, 163, 130, 059, 101, 113, 135,
146, 137, 189, 195, 063, 157, 181, 166, 052, 043, 061, 092, 124, 029, 096, 093,
094, 138, 202, 211, 129, 144, 058, 162, 168, 045, 085, 066, 082, 053, 140, 158,
159, 090, 182, 183, 051, 087, 104, 116, 117, 205, 034, 203, 222, 223, 226, 229,
207, 214, 220, 230, 070, 103, 215, 110, 068, 077, 079, 128, 153, 075, 080, 083,
084, 097, 176, 105, 134, 136, 143, 147, 111, 171, 131, 151, 156, 109, 180, 145,
062, 118, 126, 127, 152, 139, 142, 209, 081, 099, 119
RECALLING
FIRM/MANUFACTURER
Recalling Firm: AMS Innovative Center - San
Jose, CA,
Manufacturer: American
Medical Systems, Minnetonka, MN.
REASON Component missing: Some products were
issued without thermal protection switches.
VOLUME OF PRODUCT IN
COMMERCE 169 systems
DISTRIBUTION Nationwide
and Internationally
PRODUCT Ventana Image Analysis System
(VIAS) - PATHWAY anti-HER-2/neu (4B5)
primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00,
Pathology Image Analysis System,
CODE
Serial Numbers: HIS06086 HIS05042
HIS06047 HIS05018 HIS05022 HIS06046 HIS06092 HIS06059 HIS06053 HIS05053 HIS06035
HIS06038 HIS05026 HIS06100 HIS06021 HIS06074 HIS05041 HIS05017 HIS06031 HIS05051
HIS06061 HIS06028 HIS05011 HIS06083 HIS06064 HIS06057 HIS06055 HIS05047 HIS05012
HIS06054 HIS06073 HIS06088 HIS06076 HIS06002 HIS06001 HIS06004 HIS06034 HIS06015
HIS06098 HIS06069 HIS05044 HIS06033 HIS06050 HIS05046 HIS06030 HIS06095 HIS06067
HIS05028 HIS06027 HIS06056 HIS05033 HIS06049 HIS06026 HIS06008 HIS05049 HIS05013
HIS06079 HIS06072 HIS06089 HIS06084 HIS06044 HIS06007 HIS05027 HIS06051 HIS06052
HIS05025 HIS06096 HIS06066 HIS06039 HIS06065 HIS06019 HIS05052 HIS06029 HIS06022
HIS06068 HIS05048, and HIS05058
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ventana Medical Systems Inc.,
Tucson, AZ,
Manufacturer: Bd Diagnostic Systems Tripath, Durham, NC.
REASON
Incomplete upgrade: The
software upgrade from February 1, 2007 may not have been completed. This
software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu
(4B5) antibody to the VIAS system.
VOLUME OF PRODUCT IN
COMMERCE 77 devices
DISTRIBUTION Nationwide
and Canada
PRODUCT
a) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6
mm x 20 mm, P/N 7211109, Ligament Screw,
b) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6
mm x 25 mm, P/N 7211110, Ligament Screw,
c) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw,
Reverse Thread, 6 mm x 25 mm, P/N 7211111, Ligament
Screw,
d) Smith & Nephew, CALAXO Bioabsorbable
lnterference Screw, 7 mm x 20 mm, P/N 7211112, Ligament
Screw,
e) Smith & Nephew, CALAXO Bioabsorbable
lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament
Screw,
f) Smith & Nephew, CALAXO Bioabsorbable
lnterference Screw, Reverse Thread, 7 mm x 25 mm, P/N
7211114, Ligament Screw,
g) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 7 mm x 30 mm, P/N
7211115, Ligament Screw,
h) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 8 mm x 25 mm, P/N
7211116, Ligament Screw,
i) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 8 mm x 30 mm, P/N
7211117, Ligament Screw,
j) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N
7211118, Ligament Screw,
k) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 9 mm x 25 mm, P/N
7211119, Ligament Screw,
l) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 9 mm x 30 mm, P/N
7211120, Ligament Screw,
m) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 9 mm x 35 mm, P/N
7211121, Ligament Screw,
n) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 10 mm x 25 mm, P/N
7211122, Ligament Screw,
o) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 10 mm x 30 mm, P/N
7211123, Ligament Screw,
p) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N
7211124, Ligament Screw,
q) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 11 mm x 30 mm, P/N
7211125, Ligament Screw,
r) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 11 mm x 35 mm, P/N
7211126, Ligament Screw,
s) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 12 mm x 35 mm, P/N
7211127, Ligament Screw,
t) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 8 mm x 20 mm, P/N
72201069, Ligament Screw,
u) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 9 mm x 20 mm, P/N
72201070, Ligament Screw,
v) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 10 mm x 20 mm, P/N
72201071, Ligament Screw,
w) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, 11 mm x 25 mm, P/N
72201072, Ligament Screw,
x) Smith & Nephew, CALAXO
Bioabsorbable lnterference Screw, Reverse Thread, 8 mm x
25 mm, P/N 72201073, Ligament Screw, CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc.,
Endoscopy Division, Andover, MA,
Manufacturer: Smith & Nephew, Inc., Endoscopy Division, Mansfield,
MA.
REASON Patient
Reaction: Post operative condition sterile fluid pocket has been identified,
including the potential for graft failure and premature material
degradation.
VOLUME OF PRODUCT IN COMMERCE 68,285
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous,
60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22,
Catalog # 00-6200-060-22,
CODE Lot
Number: 26208600; exp. 2013-02
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN,
Manufacturer: Zimmer Manufacturing
B.V., Mercedita,
PR.
REASON Parts
missing and incomplete etch: The units may not contain the locking ring or the
etched alignment marks on the rim.
VOLUME OF PRODUCT IN
COMMERCE 31 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
1) Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42
mm, Hip Prosthesis Component,
2)
Stryker Orthopaedics UHR Universal Bipolar Component; 26 x 44 mm, Hip Prosthesis Component,
3) Stryker
Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component,
4) Stryker
Orthopaedics; UHR Universal Bipolar Component; 26 x 45 mm, Hip Prosthesis Component,
5) Stryker
Orthopaedics; UHR Universal Bipolar Component; 28 x 45 mm, Hip Prosthesis Component,
6) Stryker
Orthopaedics; UHR Universal Bipolar Component; 26 x 46 mm, Hip Prosthesis Component,
7) Stryker
Orthopaedics; UHR Universal Bipolar Component; 28 x 46 mm, Hip Prosthesis Component,
8) Stryker
Orthopaedics; UHR Universal Bipolar Component; 26 x 43 mm, Hip Prosthesis Component,
9) Stryker
Orthopaedics; UHR Universal Bipolar Component; 26 x 47 mm, Hip Prosthesis Component,
10)
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 47 mm, Hip Prosthesis Component,
11) Stryker
Orthopaedics; UHR Universal Bipolar Component; 26 x
48 mm, Hip Prosthesis Component,
12) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x
48 mm, Hip Prosthesis Component,
13) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x
49 mm, Hip Prosthesis Component,
14) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x
49 mm, Hip Prosthesis Component,
15) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x
50 mm, Hip Prosthesis Component,
16) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x
50 mm, Hip Prosthesis Component,
17) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x
51 mm, Hip Prosthesis Component,
18) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x
51 mm, Hip Prosthesis Component,
19) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x
52 mm, Hip Prosthesis Component,
20) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x
53 mm, Hip Prosthesis Component,
21) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x
52 mm, Hip Prosthesis Component,
22) Stryker Orthopaedics; UHR Universal Bipolar Component; 28
x 53 mm, Hip Prosthesis Component,
23) Stryker Orthopaedics; UHR Universal Bipolar
Component; 26 x 54 mm, Hip Prosthesis
Component,
24) Stryker Orthopaedics; UHR Universal
Bipolar Component; 26 x 55 mm, Hip Prosthesis
Component,
25) Stryker Orthopaedics; UHR Universal
Bipolar Component; 28 x 55 mm, Hip
Prosthesis Component,
26) Stryker Orthopaedics; UHR
Universal Bipolar Component; 28 x 56 mm, Hip
Prosthesis Component,
27) Stryker Orthopaedics; UHR
Universal Bipolar Component; 26 x 41 mm, Hip
Prosthesis Component,
28) Stryker Orthopaedics; UHR
Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component,
29) Stryker
Orthopaedics; UHR
Universal Bipolar Component; 28 x 56 mm, Hip
Prosthesis Component,
30) Stryker Orthopaedics; UHR
Universal Bipolar Component; 26 x 56 mm, Hip Prosthesis Component,
31) Stryker
Orthopaedics; UHR Universal Bipolar Component; 28 x
58 mm, Hip Prosthesis Component,
32) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x
61 mm, Hip Prosthesis Component,
33) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x
61 mm, Hip Prosthesis Component,
34) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x
68 mm, Hip Prosthesis Component,
35) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x
68 mm, Hip Prosthesis Component,
36) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x
72 mm, Hip Prosthesis Component,
CODE
1) Ref No: Description: Lot Code:
UH1-42-26 UHR BIPOLAR 26X42mm HD8MJA UH1-42-26 K53MND
UH1-42-26 TK6MEA;
2) Ref No: Description: Lot Code: UH1-44-26 UHR BIPOLAR
26X44mm 5NDMLA UH1-44-26 UHR BIPOLAR 26X44mm 5NEMLA
UH1-44-26 UHR BIPOLAR 26X44mm 7PDMCA UH1-44-26 UHR
BIPOLAR 26X44mm PEKMEA UH1-44-28
UHR BIPOLAR 26X44mm
2RKMED UH1-44-26 29AMPD UH1-44-26 4JDMPD UH1-44-26 4JEMPD
UH1-44-26 DT9MND UH1-44-26 M15MHD;
3) Ref No: Description: Lot Code:
UH1-44-28 UHR BIPOLAR 28X44mm 3K4MMD UH1-44-28 UHR
BIPOLAR 28X44mm 5P0MLA UH1-44-28 UHR BIPOLAR 28X44mm
JEMMNA UH1-44-28 04YMPD UH1-44-28 0YHMMD UH1-44-28
247MMD
UH1-44-28 29EMPD UH1-44-28 2HYMRA UH1-44-28 66NMKD
UH1-44-28 6W5MPD UH1-44-28 6W6MPD UH1-44-28 8XEMPD UH1-44-28 8XKMPD UH1-44-28 9W0MJA UH1-44-28 D05MKD UH1-44-28 ED8MND UH1-44-28 EP2MPA UH1-44-28 K57MND UH1-44-28 K6LMND
UH1-44-28 LA6MPA UH1-44-28 V13MLD UH1-44-28 V17MLD;
4) Ref No: Description: Lot Code: UH1-45-26 UHR BIPOLAR 26X45mm
2RJMPA UH1-45-26 UHR BIPOLAR 26X45mm 2RMMPA UH1-45-26 UHR
BIPOLAR 26X45mm K15MPA UH1-45-26 3KDMMD UH1-45-26 3KLMPD
UH1-45-26
4JHMPD UH1-45-26 637MKD UH1-45-26 75TMMD
UH1-45-26 E94MPD UH1-45-26 EDAMND UH1-45-26 EDDMND
UH1-45-26 K4VMND;
5) Ref No: Description: Lot Code: UH1-45-28 UHR BIPOLAR
28X45mm 6AWMNA UH1-45-28 UHR BIPOLAR 28X45mm 88LMNA
UH1-45-28 UHR BIPOLAR 28X45mm V1RMLD UH1-45-28 0YMMMD
UH1-45-28 3KKMMD UH1-45-28
4JJMPD UH1-45-28 6W7MPD
UH1-45-28 8XLMPD UH1-45-28 DTEMND UH1-45-28 EHRMKA
UH1-45-28 L96MPA UH1-45-28 PM5MEA UH1-45-28 PM7MEA
UH1-45-28 V1LMLD UH1-45-28 V1MMLD UH1-45-28 V1NMLD
UH1-45-28 V1TMLD;
6) Ref No: Description: Lot Code: UH1-46-26 UHR BIPOLAR
26X46mm 0A4MLA UH1-46-26 UHR BIPOLAR 26X46mm 88WMNA
UH1-46-26 UHR BIPOLAR 26X46mm D4KMDD UH1-46-26 UHR
BIPOLAR 26X46mm D7YMKA
UH1-46-26 7YYMPD UH1-46-26 8P4MLD
UH1-46-26 JD0MND;
7) Ref No: Description: Lot Code: UH1-46-28 UHR
BIPOLAR 28X46mm 155MJA UH1-46-28 UHR BIPOLAR 28X46mm
1V9MED UH1-46-28 UHR BIPOLAR 28X46mm 615MMD UH1-46-28 UHR
BIPOLAR 28X46mm 9PMMMA
UH1-46-28 UHR BIPOLAR 28X46mm
T55MEA UH1-46-28 0YJMMD UH1-46-28 248MMD UH1-46-28 29JMPD
UH1-46-28 3K2MMD UH1-46-28 4DLMMD UH1-46-28 800MPD
UH1-46-28 8XMMPD UH1-46-28 E98MPD UH1-46-28 LAPMPA
UH1-46-28 LARMPA
UH1-46-28 N8WMPA UH1-46-28 N93MPA
UH1-46-28 N94MPA;
8) Ref No: Description: Lot Code: UH1-43-26 UHR BIPOLAR
26X43mm 341MCA UH1-43-26 UHR BIPOLAR 26X43mm 4DEMMD
UH1-43-26 UHR BIPOLAR 26X43mm J9YMAD UH1-43-26 UHR
BIPOLAR 26X43mm KP6MJD UH1-43-26 1DYMPD UH1-43-26 3KHMPD
UH1-43-26 ED7MND;
9) Ref No: Description: Lot Code: UH1-47-26 UHR BIPOLAR
26X47mm 0A8MMA UH1-47-26 UHR BIPOLAR 26X47mm K1AMHA
UH1-47-26 801MPD UH1-47-26 K1AMHA;
10) Ref No:
Description: Lot Code: UH1-47-28 UHR BIPOLAR 28X47mm
87YMCA UH1-47-28 2J3MHA UH1-47-28 6W8MPD UH1-47-28 K5HMND UH1-47-28 L94MPA UHI -47-28 057MPD;
11)
Ref No: Description: Lot Code: UH1-48-26 UHR BIPOLAR 26X48mm ELYMLA UH1-48-26 UHR BIPOLAR 26X48mm LXWMHD
UH1-48-26 802MPD UH1-48-26 E99MPD UH1-48-26
RDRMEA UH1-48-26 RDVMEA;
12) Ref No: Description: Lot Code: UH1-48-28 UHR
BIPOLAR 28X48mm 0YNMMD UH1-48-28 UHR BIPOLAR
28X48mm 1A7MEA UH1-48-28 UHR BIPOLAR 28X48mm
611MMD UH1-48-28 UHR BIPOLAR 28X48mm EYRMLD
UH1-48-28 UHR BIPOLAR 28X48mm MALMDA UH1-48-28 1A7MEA
UH1-48-28 62JMKD UH1-48-28 803MPD UH1-48-28
A24MND;
13) Ref No: Description: Lot Code: UH1-49-26 UHR BIPOLAR 26X49mm
0N3MJD UH1-49-26 UHR BIPOLAR 26X49mm K22MHA
UH1-49-26 804MPD UH1-49-26 D10MKD;
14) Ref No: Description: Lot Code: UH1-49-28 UHR BIPOLAR 28X49mm 63PMDD UH1-49-28 4JNMPD UH1-49-28 D78MKA UH1-49-28
K51MND UH1-49-28 KHRMEA UH1-49-28 KHTMEA
UH1-49-28 KHWMEA UH1-49-28 MHLMKD;
15) Ref No: Description: Lot Code:
UH1-50-26 UHR BIPOLAR 26X50mm 6X5MAD
UH1-50-26 UHR BIPOLAR 26X50mm J3VMKA UH1-50-26 UHR BIPOLAR 26X50mm J84MDA UH1-50-26 KJ1MEA UH1-50-26
KJ4MEA UH1-50-26
KJ8MEA UH1-50-26 KJ9MEA
UH1-50-26 KJAMEA;
16) Ref No: Description: Lot Code: UH1-50-28 UHR BIPOLAR
28X50mm 0L7MHD UH1-50-28 UHR BIPOLAR 28X50mm
3JDMKA UH1-50-28 UHR BIPOLAR 28X50mm N4NMRA
UH1-50-28 1E6MEA UH1-50-28 1EEMPD UH1-50-28
4E4MMD UH1-50-28 685MTA UH1-50-28 6W9MPD UH1-50-28 805MPD UH1-50-28 8HMMJA UH1-50-28 8XNMPD UH1-50-28
E9EMPD UH1-50-28 EKPMEA UH1-50-28 HHYMDA
UH1-50-28 HLEMEA UH1-50-28 K5AMND;
17) Ref No: Description: Lot Code:
UH1-51-28 UHR BIPOLAR 28X51mm AD0MLA
UH1-51-28 UHR BIPOLAR 28X51mm D8XMLD UH1-51-28 0MNMJD UH1-51-28 763MMD UH1-51-28 7DJMND;
18) Ref
No: Description: Lot Code: UH1-51-26 UHR BIPOLAR 26X51mm 38RMNA UH1-51-26 UHR BIPOLAR 26X51mm 8MXMDD
UH1-51-26 D91MPD UH1-51- 26 K52MND;
19)
Ref No: Description: Lot Code: UH1-52-26 UHR BIPOLAR 26X52mm 09NMKA UH1-52-26 UHR BIPOLAR 26X52mm MVHMTA
UH1-52-26 3KTMPD UH1-52-26 8XPMPD UH1-52-26
D92MPD UH1-52-26 EDKMND UH1-52-26 K6RMND;
20) Ref No: Description: Lot Code: UH1-53-26 UHR BIPOLAR 26X53mm 0N2MJD UH1-53-26 UHR BIPOLAR 26X53mm N40MRA
UH1-53-26 UHR BIPOLAR 26X53mm XLJMKD
UH1-53-26 0N1MJD UH1-53-26 29NMPD UH1-53-26
806MPD;
21) Ref No: Description: Lot Code: UH1-52-28 UHR BIPOLAR 28X52mm
1VKMED UH1-52-28 UHR BIPOLAR 28X52mm 53MMLD
UH1-52-28 3KXMPD UH1-52-28 3KYMPD UH1-52-28
4KPMCA UH1-52-28 5JMMPD UH1-52-28 77MMLD
UH1-52-28 8XRMPD UH1-52-28 D93MPD
UH1-52-28
E9HMPD UH1-52-28 EDLMND UH1-52-28 EDRMND;
22) Ref No: Description: Lot Code:
UH1-53-28 UHR BIPOLAR 28X53mm 65KMDD
UH1-53-28 28601C UH1-53-28 29PMPD UH1-53-28 406MTA UH1-53-28 807MPD;
23) Ref No: Description: Lot Code:
UH1-54-26 UHR BIPOLAR 26X54mm 8EYMCA
UH1-54-26 4JTMPD UH1-54-26 K6VMND;
24) Catalog number; description; lot
code: UH1-55-26 UHR BIPOLAR 26X55mm REYMKD
UH1-55-26 UHR BIPOLAR 26X55mm XAHMAD UH1-55-26 8XWMPD UH1-55-26 W22MEA;
25)
Catalog Number; description; lot code: UH1-55-28 UHR BIPOLAR 28X55mm 1EHMPD UH1-55-28 UHR BIPOLAR 28X55mm D31MLA;
26) Ref No: Description: Lot Code: UH1-56-28 UHR BIPOLAR 28X56mm
8Y1MED UH1-56-28 4JWMPD UH1-56-28 8HRMCA
UH1-56-28 8Y0MPD UH1-56-28 8Y1MED UH1-56-28
K5JMND;
27) Ref No: Lot Code: UH1-41-26 A7LMKD UH1-41-26 DT8MND;
28) Ref
No: Lot Code: UH1-54-28 5JNMPD UH1-54-28 EDTMND UH1-54-28 HE2MND UH1-54-28 KX6MKD UH1-54-28 LPYMNA
UH1-54-28 NARMKD;
29) Ref No: Lot Code: UH1-56-28 4JWMPD UH1-56-28 8HRMCA
UH1-56-28 8Y0MPD UH1-56-28 8Y1MED UH1-56-28
K5JMND;
30) Ref No: Lot Code: UH1-56-26 4JVMPD UH1-56-26 8XXMPD UH1-56-26
DTPMND;
31) Ref No: Lot Code: UH1-58-28
3L0MPD UH1-58-28 3L1MPD
UH1-58-28 86TMND
UH1-58-28 86VMND;
32) Ref No: Lot Code: UH1-61-26 EDWMND;
33) Ref No: Lot
Number: UH1-61-28 7DVMND UH1-61-28 DTRMND;
34) Ref No: Lot
Number: UH1-68-26 80AMPD UH1-68-26 A34MPD;
35) Ref No: Lot Number: UH1-68-28
MR0MMD;
36) Ref No: Lot Number: UH1-72-28 05AMPD;
RECALLING
FIRM/MANUFACTURER Styker Howmedica Osteonics Corp., Mahwah, NJ,
REASON
Incorrect part:
Device may have an incorrect locking ring assembled with the UHR bipolar
head.
VOLUME OF PRODUCT IN COMMERCE 360
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Siemens Magnetom Harmony Mobile MRI System. Model Number:
4759309,
b) Siemens Magnetom
Harmony syngo. Model Number: 7106714,
c) Siemens Magnetom Harmony sygno. Model Number: 7104693,
d)
Siemens Magentom Symphony, Model Number: 4760265,
e)
Siemens Magnetom Sonata syngo, Model Number: 7106425,
f) Siemens Magnetom Symphony syngo, Model Number: 7104594,
g) Siemens Magentom Symphony
syngo Upgrade, Model Number: 7106557,
h) Siemens Magnetom Sonata syngo, Model Number: 7104719,
CODE
a) Serial Numbers: 10018, 10022,
10029, 10032 10036, 10160, 10167, 10255, 10289, 10316,
10386, and 10429;
b) Serial Numbers: 10510, 10555, 10565, 10620,10663, 10665,
and 10669;
c) Serial Numbers: 11006, 11044, 11065, 11090, 11102, 11112,
11115, 11127, 11157, and 11162;
d) Serial Numbers:
13309 and 13390;
e) Serial Number: 21936;
f) Serial Numbers: 22021, 22024,
22060, 22074, 22079, 22108, 22115, 22116, 22121, 22127,
22172, 22196, 22225, 22242, 22272, 22306, 22311, 22342, 22352, 22353, 22356, 22402, 22440, 22441, 22446, 22471, 22498, 22510,
22520, 22523, 22530, 22561, 22565, 22596, 22598, 22604,
22619, 22621 22622, 22636, 22674, 22690, 22698, 22711,
22801, 22810, 22825, 22835, 22836, 22865, 22881, 22885, 22907, 22911, 22914, 22916, 22944, 22967, 23001, 23057, 23059,
23085, 23099, 23104, 23132, 23136, 23156, 23176, 23199,
23218, 23247, 23252, 23255, 23284, 23315, 23323, 23357,
23381, 23491, 23497, 23507, 23538, 23552, 23574, 23578, 23579, 23580, 23585, 23590, 23594, 23596, 23602, 23604, 23605,
23610, 23613, 23628, 23641, 23642, 23672, 23682, 23687,
23691, 23698, 23731, 23760, 23762, 23764, 23782, 23783,
23788, 23796, 23804, 23823, 23834, 23839, 23883, 23885, 23902,
23904, 23913, 23919, 23932, 23943, 23950, 23956, 23984,
23986, 23987, 23994, 23997, 23999, 24017, 24019, 24022,
24030, 24043, 24071, 24099, 24104, and 24107;
g) Serial Numbers: 14001,
14087, 14101, 14182, 14184, 14186, 14206, 14220, 14235,
14236, 14238, 14247, 14252, 14264, 14272, 14276, 14278, 14312, 14334, 14344, 14357, 14359, 14360, 14362, 14268, 14427, 14424, 14427,
14430, 14431, 14434, 14436, 14438, 14443, and
14447;
h) Serial Numbers: 21238 and 21269
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA,
Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions,
Erlangen, Germany.
REASON Magnet Quench,
unintended- magnet of a mobile MRI system quenched into the exam
room.
VOLUME OF PRODUCT IN COMMERCE 156
units
DISTRIBUTION Nationwide
PRODUCT
a) Draeger TI500. Isolette Infant Incubator. Catalog Number:
MU20505,
b) Draeger GT500. Globe
Trotter Transport System. Catalog Number: MU20508,
c) Draeger Globe Trotter IC, Catalog Number: MU20509,
CODE
a) Serial Numbers: PK05967, PK05990,
PK05973, PK05986, PK05987, PK05988, PK05962, PK05963,
PK05964, PK05965, PK05989, PK05976, PK05972, LT05951,
PK05968, LT05952, PK05969, and PK05974;
b) Serial Numbers: PK00983 and
PK00982;
c) Serial Numbers: QT05675, QT05676, ST05708, and
ST05704
RECALLING FIRM/MANUFACTURER Draeger Medical,
Inc., Telford, PA,
REASON Heating failure - The power board which
controls the incubator heater may not regulate the temperature properly
resulting in a high temperature alarm and a loss of temperature control within
the patient compartment.
VOLUME OF PRODUCT IN COMMERCE 24
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
UniCel
Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access
Immunoassay Systems, Part Number : 386167,
CODE Lot Code: 1201291 &
1201431
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Beckman Coulter, Inc., Brea, CA,
Manufacturer: Nypro, Gurnee, IL.
REASON
Erroneous Results - UniCel Dxl Access
Immunoassay Systems Reaction Vessels have been found to be defective and there
is a potential for an increase in signal leading to an erroneous
result.
VOLUME OF PRODUCT IN COMMERCE 264 units in US; 9
units in Canada
DISTRIBUTION Nationwide and
Canada
PRODUCT
Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30,
Expires October 19, 2007, RCR#2018433-10/25/07-006R,
CODE Lot Number: 52044HW00
RECALLING
FIRM/MANUFACTURER Abbott Laboratories, Inc., South Pasadena, CA
REASON
Three potential issues with Creatine
Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient
results (2) An Increased imprecision, or (3) Error Code 1054 (Unable to
calculate results, Reaction Failure) on Architect cSystems.
VOLUME OF
PRODUCT IN COMMERCE 714
kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Stryker Orthopedics, Locking Screw, T7, Catalog Number: 40-27622,
Size: 2.7X22MM, Non Sterile, Titanium Alloy, CODE Lot Numbers: H8W00F0B41; H9H00FB41, and
H9R00F0B41
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Stryker Howmedica Osteonics Corp., Mahwah, NJ, Manufacturer: Stryker Leibinger
Gmbh, Freiburg, Germany.
REASON Screws do not have locking
threads.
VOLUME OF PRODUCT IN COMMERCE 100
units
DISTRIBUTION Nationwide
PRODUCT
Gambro cartridge blood set with Phoenix Hemodialysis System,
CODE
All catalog numbers involving the
Gambro Cartridge Blood Sets: 6184071, 6186886, 6186886, 6187439, 6187660,
6187686, 617894, 6032536, 6188320, 6189153, 6189211, 6189450, 6280481, 6280598,
003409-400, 003409-410, 003410-500, 003410-510, 004310-710, 003411-500,
003412-500, 003414-500, 003414-510, 003415-510, 003422-500, 003422-515,
003422-520, 003429-500
RECALLING FIRM/MANUFACTURER Gambro
Dasco S.p.A. Monitor Division, Medolla, Italy
REASON Tube kinking -
Improper tubing installation may result in serious injury or
death.
VOLUME OF PRODUCT IN COMMERCE 66,438,390
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Parks
Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes),
b)
Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes),
c) Parks Medical Ultrasonic Doppler Flow Detector,
Model 811-BTS (finished assembly without accompanying
probes),
d) Parks Medical Dual Frequency Doppler
Vascular Flow Detector, Model 915-BL (finished assembly
without accompanying probes), CODE
a) Serial Numbers: 811-B-600001762 thru
600001769 (to Australian consignee) 811-B-600001876 thru
600001880 and 600001882 thru 600001884 (to Brazilian
consignee) 811-B-600001896 thru 600001901 811-B-600001910 thru 600001912 811-B-600001926 811-B-600001955 and 1956 811-B-600001959
thru 1962
811-B-600001974 and 1975 811-B-600001998
811-B-600002005 thru 2007 811-B-600002010 thru 2019
811-B-600002022 thru 2027 811-B-600002029 thru 2031
811-B-600002036 thru 2039 811-B-600002050 thru 2055 811-B-600002057 thru 2059 Code Breakdown Example: 811B-600001896; 811B =
the series; 6 = the
version; 00 = the revision; 001896 =
the unique identifier number;
b) Serial Number: 811-B-400001438;
c) Serial
numbers to be provided by firm;
d) Serial Numbers:: 915B-000001329 thru 1332
Code Breakdown Example: 915B-000001329; 915B = the final
assembly of series 915-BL; 0 = the version; 00 = the
revision; 001329 = the unique identifier number
RECALLING
FIRM/MANUFACTURER Parks Medical Electronics Inc., Aloha, OR,
REASON
Premature battery failure: Wrong acid
flux used on circuit board which may lead to premature battery failure of
ultrasonic non-directional doppler flowmeter.
VOLUME OF PRODUCT IN
COMMERCE 164 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for
use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide
per tyvek pouch, 20 pouches per box,
CODE Lot Numbers: M102250 and
M105440
RECALLING FIRM/MANUFACTURER Civco Medical
Instruments Inc., Kalona, IA,
REASON Incorrect Needle Guide- The individual
pouches contained V53W Endocavity Needle guide (p/n/034-054) instead of the
Shimadzu T/R Needle guide (p/n134-054).
VOLUME OF PRODUCT IN
COMMERCE 7
boxes
DISTRIBUTION Nationwide
PRODUCT
a) AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder
Number: 653005,
b) AlloCraft DBM
with Syringe Assembly, 10 CC,
CODE
a) Lot Numbers: B07F25I; Exp 4/2009;
B07F25J: Exp 4/2009; and B07425H; Exp 3/2009.
b) Lot
Numbers: B06E02E; Exp 3/2008; B06E02F, Exp. 3/2008;
B07C29B, Exp 2/2009; B07E14E, Exp 3/2009; B07G24B, Exp 5/2009; B07G24C, Exp 5/2009; B07G24E, Exp 5/2009; and B07G24F,
Exp 5/2009
RECALLING FIRM/MANUFACTURER LifeCell
Corporation, Somerville, NJ,
REASON Improper donor
screening test; diagnostic test kits were used in lieu of a donor screening test
kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening
test found samples non-reactive for both Hepatitis B Surface Antigen and
Hepatitis B Core IgM/IgG Antibody)
VOLUME OF PRODUCT IN
COMMERCE 156 kits
DISTRIBUTION NJ