MAY 2008
WEEK ENDING MAY 3
PRODUCT ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system:
a) Material Number 8245875;
b) Material Number 8246951;
c)
Material Number 8267697;
CODE
a)
Serial Numbers: 54602 56482 55620 53997 51959 56156 56192 56040 53614 56483
56651 56526 60018 60247 60348 60835 60870 60339 56577 53519 62170 59126 62257
60258 62370 63164 54043 63929-1 55706 56104 56124 56654 56922 57303 57380 57494
59024 59131 59174 59176 59221 60054 60057 60228 60237 60251 60254 60282 60285
60338 60438 60450 60460 60461 60601 60620 60625 60631 60633 60634 60645 60647
60661 60728 60860 60875 60880 60947 61043 61053 61067 61108 61114 61118 61120
61121 61123 61127 61212 61221 61225 61290 61422 61544 61661 61673 61745 61751
61771 61974 62040 62053 62057 62116 62128 62130 62132 62233 62240 62282 62396
62431 62543 62644 62738 62764 62790 62838 62840 62861 62871 62916 62924 63023
63097 63101 63103 63114 63115 63146 63165 63184 63196 63203 63205 63208 63337
63366 63368 63389 63408 63420 63455 63462 63468 63470 63566 63573 63690 63856
63862 63867 63878 63885 63886 63899 63928 64051 50970 51577 52356 52448 52565
52732 52743 52770 53437 53712 53725 54223 54549 54937 55091 55092 55156 55272
55734 54640 55197 53060 54446 54254 54423 54766 52071 52110 52427 53011 55012
54686 51080 52076 53357 54552 53467 54380 54688 52959 53932 52034 54121 52051
53446 50447 50834 50975 51048 51073 51571 52865 53252 53626 53631 53643 53844
53950 54065 54123 54317 54389 54521 54529 54546 54603 54934 54949 55082 55104
55135 55140 55441 55461 55838 55895 56355 57017 55351 55244 54315 54199 54366
51648 53978 51023 54489 54536 54808 50140 54130 53579 55553 50194 55853 53590
55477 53524 54958 63546 56823 56717 56758 56786 56196 55713 56123 56247 56248
56625 62755 50235 54425 53244 53803 50228 53182 54361 and 53990;
b) Serial
Numbers: 62519 62835 63108 56191 and 54332;
c) Serial Numbers: 63168 61316
62848 63188 63275 and 63727
RECALLING
FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Mountain
View, CA,
REASON Measurement Error affecting all Sequoia
systems using the PAL video standard configuration and have a perspective PC
installed: 1) The Sequoia" system is operating at a software revision below 8.0.
2) The Sequoia" system is configured to PAL video mode (normal for systems
running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display
options listed above, an image or clip is then stored or saved to the system
hard drive, MOD or a storage device. (This image or clip is known as a secondary
capture.). 4) The secondary capture images/clips are subsequently recalled for
review and measurements are made. If a measurement is taken on these secondary
capture images/clips, an error can occur. The error is 0% if taken in the same
axis that calibration was performed, and ranges proportionately up to 9% if the
measurement is taken orthogonal or at right angles (90 degrees) to the axis that
was used for calibration. If calibration was done on the horizontal axis, then
vertical measurements are underestimated. If calibration was done on the
vertical axis, then horizontal measurements are overestimated.
VOLUME
OF PRODUCT IN COMMERCE 280
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
1) BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask,
and/or accessories for sleep therapy and ventilation
devices,
2) Filters under the following brand names: a)
filter std incoming 7100 CPAP qty 1
model number 1039618;
b) filter reusable PLV 2/pkg model number 35220;
c) LX UL
Fine Filter 2 pack model number 1006193;
d) RP-M Series
Ultrafine Filters 6 pack model number 1029331;
e) RP
Vision OM Reg Filter (ASCO) model number 1007547;
and f)
REPL Filters package of 4 model number 929-4. Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
3) Non-continuous ventilator accessories under the
following brand names:
a) Adult ECG Electrodes model
number 1016360;
b) O2 Enrichment Attachment BX 10 model
number 312010;
c) O2 Enrichment Attachment Single model
number 312710;
d) Alice 5, Domestic model number 1017226;
e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number
CA701HS;
f) BIPAP Auto M.W/Humid, W/SmartCard, US model
number DS700HS;
g) BIPAP Auto M, W/SmartCard, US model
number DS700S;
h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716;
i) BIPAP
Harmony, Intl model number 1012823;
j) BIPAP Plus M,
US model number DS600;
k) BIPAP Plus M, W/Humid US
model number DS600H;
l) BIPAP S/T Core Pkg NA model
number 1014248;
m) BIPAP S/T North America model
number 1012885;
n) BIPAP Vision Filter Pack model
number 582101;
o) Duet LX/BIPAP Pro/Synch Pollen
QTY 1 model number 1039611;
p) FLXTB, 5 ½ inch STD,
22 mm, CE model number 1006042;
q) FLXTB, 6 in
Trach 15 mm taper, CE model number 1004968;
r) GP
UL-Fine Filter 2 pack model number 1006190;
s)
Incoming Filter 7000, 7001 CPAP model number 7070;
t) Infant ECG Electrodes model number 1016361.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
4) Inv Circuit Assembly Box 10
CE model number 652002. Filter, mask, and/or
accessories
for sleep therapy and ventilation devices,
5) M Series
Heated Humidifier Domestic model number 1022257. Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
6) Mouthpiece, Angled 22mm CE model number FC06566.
Filter, mask, and/or
accessories for sleep therapy and
ventilation devices,
7) Omni Lab Core Domestic model
number 1043343. Filter, mask, and/or accessories
for
sleep therapy and ventilation devices,
8) PLV-102, 100V
50/60 HZ Japanese model number 87006. Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
9) Power Cord Accessory under the following brand
names: a) Power Cord W/C7 End
Europe 5 ft model number
1039014 and b) Power Cord W/C7 End USA/CAN model
number
1005894. Filter, mask, and/or accessories for sleep therapy and ventilation
devices,
10) Non-continuous
ventilators accessories under the following brand names:
a) REM Auto M. w/Humid, w/Smartcard A Flex US model number DSS10HS;
b) REM Auto M. w/SC, w/Humid A Flex CAN model number
CA511HS. Filter,
mask, and/or accessories for sleep
therapy and ventilation devices,
11) Non-continuous ventilator accessories under the following
brand names:
a) REMStar (Tower) Ultrafine Qty
1 model number 1036915,
b) REMStar Auto M.
w/Humid. w/Smartcard. US model number DS500HS;
c) REMStar Auto M. w/Smartcard A FLEX US model number DS510S;
d) REMStar Auto M. w/Smartcard, CNDA model
number CA501S;
e) REMStar Auto M w/Smartcard
Intl model number IN501S;
f) REMStar Auto M
w/Smartcard US model number DS500S;
g)
REMStar Auto w/C-FLEX CANADA model number CA1017454;
h) REMStar Auto w/C-FLEX Domestic Core Pkg model number
1017476.
Filter, mask, and/or accessories for
sleep therapy and ventilation devices,
12) REMStar Heated Humidifier Pkg model number 1005792.
Filter, mask, and/or
accessories for sleep
therapy and ventilation devices
13) Non-continuous
ventilator accessories under the following brand names:
a) REMStar M US model number DS100;
b) REMStar M w/Humid US model number DS100H.
Filter, mask, and/or accessories for sleep therapy and
ventilation devices,
14) Non-continuous ventilator accessories under the following
brand names:
a) REMStar Plus M US model
number DS200;
b) REMStar Plus M w/Humid AHP
model number AHP200H;
c) REMStar Plus M
w/Humid US model number DS200H;
d) REMStar
Plus M w/Humid, w/Smartcard, AHP model number AH200HS;
e) REMStar Plus M w/Smartcard, US model number DS200S;
f) REMStar Plus w/C Flex Dom model
number 1009586.
Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
15) Non-continuous ventilator accessories
under the following brand names:
a) REMStar
Pro2 Domestic model number 1020923;
b)
REMStar Pro M, w/Humid w/Smartcard US model number DS400HS;
c) REMStar Pro M w/Smartcard US model number
DS400S;
d) REMStar Pro/Plus Silencer Cap model
number 1005962;
e) REMStar Pro/Plus/Auto/Lite
Pollen model number 1005964;
f) REMStar
Pro/Plus/Auto/Lite Pollen SNGL model number 1001389;
g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945;
h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1
model number 1039607.
Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
16) Rotating Connector Packaged model
number 302209. Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
17) Non-continuous ventilator accessories under the following
brand names:
a) RP-L ComfortGel Cush and Flap
model number 1031404;
b) RP-M ComfortGel Cush
and Flap model number 1031403. Filter, mask, and/or
accessories for sleep therapy
and ventilation devices,
18) RP M Series Pollen Filter
Kit 1 pack model number 1035443, Filter, mask, and/or
accessories for sleep therapy and
ventilation devices,
19) Non-continuous ventilator
accessories under the following brand names:
a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S
ComfortGel Cush and
Flap model number 1031392. Filter, mask, and/or
accessories for sleep therapy and
ventilation devices,
20) Power Supply under the
following brand names:
a) RP, Power Supply
Assembly model number H3600-015,
b) RP,
Wiring Harness, Lamp Holder model number H3600-020. Filter, mask,
and/or accessories
for sleep therapy and ventilation devices,
21) RP-Assy,
Cover, DC-5 pack model number F35933. Filter, mask, and/or
accessories for sleep therapy and ventilation
devices,
22) Non-continuous ventilator accessories
under the following brand names:
a) RP-BIPAP
Flow Pick-Up Tube Kit model number 332185;
b)
RP-BIPAP M Series Keypad model number 1038122; and
c) RP-BIPAP Pro 2 /Plus Tubing Kit model
number 1020358.
Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
23) RP-Cable DC 6
w/Ring PLV RBL POR model number FC07270. Filter, mask,
and/or accessories for sleep therapy and
ventilation devices,
24) RP C-Flex Mini Din Plug model
number 1011220. Filter, mask, and/or accessories
for sleep therapy and ventilation devices,
25) Non-continuous ventilator accessories under the
following brand names:
a) RP-ComfortGel Gel
Cushion M model number 1009050;
b) RP-ComfortGel Gel Cushion P model number 1009048;
c) RP-ComfortGel Gel Cushion S model number
1009049;
d) RP-ComfortGel Silicone Flap L
model number 1009109;
e) RP-ComfortGel
Silicone Flap M model number 1009054; and
f)
RP-ComfortGel Silicone Flap S model number 1009053.
Filter, mask, and/or accessories for sleep
therapy and ventilation devices,
26) RP Diaphragm Exhalation model number FC06372. Filter, mask,
and/or
accessories for sleep therapy and
ventilation devices,
27) RP Duet LX/Pro Out Port w/Seal
model number 622239. Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
28) RP-Leaf, Check valve-5 pk model number F33440. Filter, mask,
and/or
accessories for sleep therapy and
ventilation devices,
29) RP-REM Auto w/C-FLEX/REM Pro
Tubing Kit model number 1008492 and RP-
REM
Power Cord N. AMER model number 362524. Filter, mask, and/or
accessories for sleep therapy and ventilation
devices,
30) RP-REMStar Plus Keypad model number
1006852. Filter, mask, and/or
accessories for
sleep therapy and ventilation devices,
31) Continuous
ventilator accessories under the following brand names:
a) RP-Seal, Spring-5 pk model number F35465;
b) RP-Seal, Greece, Ballscrew model number
F35036;
c) RP-Tub PVC 1/8 in x ¼ 50 ft model
number 1008841;
d) RP-Vision Filter Cover
model number 1003444;
e) RP-Vision RS-232 HRN
ABV 106K model number 1004699; and
f)
RP-Wrap, Cord model number F35195.
Filter,
mask, and/or accessories for sleep therapy and ventilation devices,
32) APNEA monitor
accessories under the following brand names:
a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422;
b) SM 2/2 PS Europe Patient Cable, Metal
model number 1030194; and
c) Smartmonitor 2
with modem, PCMCIA model number 4003.
Filter,
mask, and/or accessories for sleep therapy and ventilation devices,
33) Breathing
Frequency Monitor Stardust 2 Domestic model number 1025720.
Filter, mask, and/or accessories for sleep
therapy and ventilation devices,
34) Non-continuous ventilators under the following brand names:
a) Sync S/T Lab, w/o modem US/CAN model
number 1010771;
b) Sync S/T Lab, w/o modem
US/CAN-RENT model number R1010771;
c)
Synchrony S w/o modem US/CAN model number 1002816;
d) Tranquility Ultrafine Qty 1 model number
1039671; and
e) Tubing Coupler model number
300065. Filter, mask, and/or accessories for
sleep therapy and
ventilation devices,
35) Stardust Flexible Y Sensor
Probe model number 612054. Filter, mask, and/or
accessories for sleep therapy and ventilation
devices,
36) ECG Lead Set 60 in SOC to Snap model
number 8049-1. Filter, mask, and/or
accessories for sleep therapy and ventilation devices,
37) Oximeter Patient Cable Masimo 8 ft model number H5870.
Filter, mask, and/or
accessories for sleep
therapy and ventilation devices,
38) Oximetry Ear Clip
Sensor model number 948. Filter, mask, and/or accessories for
sleep therapy and ventilation devices,
39) Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter,
mask, and/or
accessories for sleep therapy
and ventilation devices,
CODE Lot
Numbers 071010, 071011, and 071012
RECALLING
FIRM/MANUFACTURER Respironics, Inc., Murrysville, PA,
REASON Foreign material: Glass fragments may present in
the plastic bag material used to ship components.
VOLUME OF PRODUCT
IN COMMERCE 20,950
units
DISTRIBUTION Nationwide
PRODUCT
CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire
Automated Hematology Analyzer. Each package is identified with product
description "CDS HGB SRNG W/BU",
CODE All Hemoglobin Reagent Syringes, List No. 08H49-02,
with packaging dates between May 8, 2007 and November 29,
2007
RECALLING FIRM/MANUFACTURER Abbott Laboratories,
Santa Clara, CA,
REASON Count may be out of
specification--Hemoglobin background count may be out of specification (high)
after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with
packaging dates between May 8, 2007 and November 29, 2007.
VOLUME OF
PRODUCT IN COMMERCE 2,742
syringes
DISTRIBUTION Nationwide and Internationally
WEEK ENDING MAY 10
PRODUCT
a)
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000,
b) Pathway Balloon Expandable Ureteral Access Sheath-
11/14/36, Ureteral dilator, Catalog Number: 255101;
Product Number: M0062551010,
c) Pathway Balloon
Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020,
d) Pathway Balloon Expandable Ureteral Access Sheath-
13/16/28, Ureteral dilator, Catalog Number: 255103;
Product Number: M0062551030,
e) Pathway Balloon
Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040,
f) Pathway Balloon Expandable Ureteral Access Sheath-
13/16/46, Ureteral dilator, Catalog Number: 255105;
Product Number: M0062551050,
g) Pathway Balloon
Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060,
h) Pathway Balloon Expandable Ureteral Access Sheath-
12/15/46, Ureteral dilator, Catalog Number: 255108;
Product Number: M0062551080,
CODE
a)
Lot numbers: W03-1606, W03-1649, , W03-1700, W03-1702, W03-1924, W03-2077, W03-2143, W03-2277, W03-2283;
b) Lot numbers:
W03-1527, W03-1579, W03-1587, W03-1595, W03-1623, W03-1644, W03-1753, W03-1786, W03-1787, W03-1813, W03-1832,
W03-1938, W03-2108, W03-2110, W03-2139, W03-2271,
W03-2278, W03-2279, W03-2280, W03-2535, W03-2589;
c)
Lot numbers: W03-1613, W03-1747, W03-1805, W03-1945, W03-2111, W03-2272, W03-2484, W03-2577;
d) Lot numbers: W03-1473,
W03-1474, W03-1909, W03-2055, W03-2112, W03-2144,
W03-2232, W03-2284, W03-2232, W03-2391, W03-2464, W03-2579;
e) Lot numbers:
W03-1482, W03-1491, W03-1508, W03-1524, W03-1740, W03-1917, W03-2107, W03-2113, W03-2214, W03-2216, W03-2236,
W03-2239, W03-2240, W03-2285, W03-2354, W03-2410,
W03-2446, W03-2457, W03-2483, W03-2580;
f) Lot numbers: W03-1464, W03-1767,
W03-2106, W03-2215, W03-2241, W03-2242, W03-2275,
W03-2470, W03-2566;
g) Lot numbers: W03-2337, W03-2359, W03-2392, W03-2553,
W03-2554, W03-2590;
h) Lot Number: W03-2341, W03-2357, W03-2395,
W03-2578
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Boston Scientific Corporation, Natick, MA,
Manufacturer: Onset Medical Corporation, Irvine, CA.
REASON
Sheath Removal
Difficulty: Users experience difficulty in removing the
sheath.
VOLUME OF PRODUCT IN COMMERCE 1,998 units (total
also includes Recall # Z-0912-2008 – Class
III)
DISTRIBUTION Nationwide
PRODUCT
a)
Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1,
b) Siemens Coherence Therapist system, Part No:
7339125, medical charged-particle radiation therapy
system with software version 2.1,
c) Siemens Coherence
Impression Therapist system, Part No: 7341410, medical
charged-particle radiation therapy system with software version 2.1,
d) Siemens Primeview 3i medical
charged-particle radiation therapy system, Part No:
7341428, with software version 3i,
e) Siemens AG
Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345411,
f)
Siemens Impression Therapist 3rd Party V&R medical charged-particle
radiation therapy system, Part No: 7345429,
g) Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437,
h) Siemens Coherence Therapist 2.0 medical
charged-particle radiation therapy system, Part No:
8139839, with software version 2.1,
i) Siemens
Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0,
j) Siemens Coherence Therapist 2.1 medical charged-particle
radiation therapy system, Part No: 8147667, with software
version 2,
k) Siemens Primeview 3i 2.1 medical
charged-particle radiation therapy system, Part No:
8147675, with software version 3i,
CODE
a) Serial Numbers: 84601, 84602, 85703,
85714, 85718, 85720, and 00E0815479E1;
b) Serial Numbers: 10007, 10010,
10015, 10017, 10020, 10026, 10028, 10030, 10037, 10038,
10001, 10003, 10004, 10005, 10008, 10009, 10011, 10019, 10027, 10031, 10039, 11004, 11006, 10006, 10018 ,10021, 10022, 10024,
10025, 11005, 10016, 10023, 10029, 10032, 10033, 10035,
10036, 10040, 11001, and 11008;
c) Serial Numbers: 2801, 10201, 14101, 22201,
56302, 57401, 62701, 79102, 93301, 98001, 00E0815462E6,
00E08154754E, 00E081548949, 102001, 1601, and 39901;
d) Serial Numbers:
102301, 104201, 00E0815462E6, 5602, 48701, 57401;
e) Serial Numbers:
24801;
f) Serial Number: 735429;
g) Serial Numbers: 10017;
h) Serial
Numbers: 10035, 10037, 15901, 10020, 10030, 10034, 10002;
i) Serial
Numbers: 10007, 10021, and 10014;
j) Serial Numbers: 10007, 10010, 10015,
10017, 10020, 10026, 10028, 10030, 10037, and 10038;
k) Serial Numbers: 3764, 10003, 10014, 10017, 10020, 10005, 10007, 10008,
10010, 10011, 10013, 10028, 10001, 10006, 10022, 10026,
10033, 10002, 10018, 10019, 10021, 10023, 10024, 10025,
10032, 10048
RECALLING FIRM/MANUFACTURER Siemens Medical
Solutions, USA, Inc., Concord, CA
REASON Image Orientation Incorrect
(Image Shifts) - 1) if the reference image has been calibrated for centering and
the reference image is used for patient positioning, the image will shift when
the positioning tools are used. 2) This problem occurs only when non-square
reference images are used, such as when images are cropped. At this point, the
images will refresh, and the center of the reference image will
shift.
VOLUME OF PRODUCT IN COMMERCE 118
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Leonardo
Workstation Picture Archiving and Communication System, Model Number: 7129534,
Software Version: VB30B,
CODE
Serial
Numbers: 10483, 10651, 10628, 10488, 10605, 10676, 10658, 10421, 10685, 10724,
10584, 10619, 10626, 10629, 10635, 10694, 10706, 10438, 10600, 10668, 10655,
10436, 10606, 10702, 10433, 10558, 10636, 10642, 10692, 10698, 10412, 10440,
10539, 10613, 10674, 10621, 10634, 10583, 10684, 10476, 10414, 10664, 10671,
10712, 10472, 10567, and 10641
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA,
Inc., Malvern, PA,
Manufacturer:
Siemens AG, Medical Solution, Forchheim, Germany.
REASON
Incorrect display: The orientation
labels will be incorrectly displayed on the reconstructed InSpace 3-D image if
the orientation was not originally HFS on the acquisition
system.
VOLUME OF PRODUCT IN COMMERCE 47
units
DISTRIBUTION Nationwide
PRODUCT Seradyn
QMS Vancomycin reagents, Part Number: 0373589,
CODE All lots (lots 501930, 502063, 502074,
600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and
703027)
RECALLING FIRM/MANUFACTURER Seradyn, Inc.,
Indianapolis, IN
REASON False negative test results due to
Interfering substances (heterophile antibodies) in the patient's blood may
produce erroneously low results.
VOLUME OF PRODUCT IN
COMMERCE 1,819 kits plus bulk material for 1,863
kits
DISTRIBUTION Nationwide and Internationally
PRODUCT GE
Centricity PACS RA1000 Workstation; for diagnostic image analysis,
CODE
Software versions 2.1.X. and
3.0.X
RECALLING FIRM/MANUFACTURER GE Healthcare
Integrated IT Solutions, Barrington, IL
REASON Report missing
characters: Four special characters, when entered into the exam notes, are not
transferred to the preview panel or hard copy printout (greater than [>],
less than [<], quotation mark ["], and apostrophe [']). This may not be
evident to the end user, as the symbols only appear when the Exam Note window is
open.
VOLUME OF PRODUCT IN COMMERCE 423 units nationwide;
134 units internationally
DISTRIBUTION Nationwide and
Internationally
PRODUCT Stryker
Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for
use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, CODE
Lots 05167CG2, 05192012,
05223012 and 06335012.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of
Stryker Corporation, Portage, MI,
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR.
REASON
Sterility may be compromised,
as the packaging may have channels in the packaging seal.
VOLUME OF
PRODUCT IN COMMERCE 25 boxes of
6
DISTRIBUTION Nationwide
PRODUCT Pathway
Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog
Number: 255107; Product Number: M0062551070,
CODE
Lot numbers: W03-2339, W03-2342,
W03-2362, W03-2382, W03-2409, W03-2431, W03-2434, W03-2436, W03-2439, W03-2479,
W03-2482, W03-2550, W03-2555, W03-2581, W03-2591
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation,
Natick, MA,
Manufacturer: Onset Medical
Corporation, Irvine, CA.
REASON Sheath Removal Difficulty: Users
experience difficulty in removing the sheath.
VOLUME OF PRODUCT IN
COMMERCE 1,998 units (total also includes Recall #
Z-0905/Z-0913-2008 – Class II
Recalls)
DISTRIBUTION Nationwide
PRODUCT
a)
Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part
Number: 626554,
b) Cytomics FC
500 MPL Flow Cytometry System with CXP Software, Software
Version 2.2, Automated differential cell counter, Part Number 626553,
CODE
a)
Serial numbers: AJ50363, AK25191, AK39273, AJ30194AK02009, AK24144, AJ32209, AL13073, AJ43303, AK32209, AJ50358, AL17100,
AK24164, AJ47338, AJ13070, AL06029, AJ13071, AK32212,
AK32210, AJ39264, AJ43304;
b) Serial Numbers: AL11058, AK20149, AJ37243,
AJ08035, AK16130, AK01004, AJ33215, AK16129, AK25182,
AK51355, AL13064, AJ38253, AK51353, AK07059, AL12062,
AJ40271, AJ02008, AJ50371, AK07058, AL21134, AJ01002,
AK12093, AL15085, AL14077, AJ30191, AJ48342, AK20152, AK07060, AJ37246, AJ06026, AK32539, AJ39259, AL04022, AJ37240, AK48336,
AJ46318, AJ14074, AJ17095, AK34227, AJ47331, AJ48341,
AJ33210, AK48347, AK20158, AK12095,
AK16131, AK19146,
AK17138, AJ25164, AJ24147, AJ51381, AJ48339, AK51359,
AJ49351, AL14082, AL22140, AJ24155, AJ47332, AK51358, AL23144, AJ24151, AJ49348, AK51380, AJ38250, AK48343, AK17135, AK18141,
AK09075, AK13103, AJ29184, AJ30189, AJ02006, AJ14075,
AJ14073, AJ15079, AJ16087, AJ16085, AJ15078, AJ16083,
AJ19103, AJ19111, AJ21116, AJ19109, AJ21114, AJ21115,
AJ21117, AJ22121, AJ22122, AJ23135, AJ25165, AJ24156, AJ25159, AJ24154, AJ25167, AJ25161, AJ47327, AK07062, AK33215, AL18108,
AL20125, AJ17091, AK34232, AJ25160, AJ25163, AK05025,
AJ29181, AJ50366, AK48328, AJ44313, AK51370, AK34230,
AJ38248, AL19111, AJ12063, AJ44309, AJ22124, AK08071,
AK48334, AK25177, AJ48344, AJ42294, AK51372, AL12063, AJ24158, AJ46319, AJ43298, AK30199, AK20153, AK51354, AJ31195, AJ49349,
AJ12064, AK33225,
AJ35229, AK17140, AJ29183, AK16127,
AJ36234, AK17134, AL09044, AJ48340, AK19147, AK39264,
AL21133, AL06033, AJ19110, AJ10048, AK51361, AJ24148,
AJ50368, AJ11056, AJ34221, AJ03012, AK19148, AK06051, AK34233, AK39246,
AJ14072, AJ44316, AJ42292, AK48338, AK34229, AJ29182,
AK18139, AK08066, AK44284, AJ05020, AK30204, AK08063,
AJ34217, AJ23129, AJ23134, AJ34226,
AJ37238, AK25181,
AK34231, AK34228, AK34234, AK48342, AJ24142, AK39266,
AJ47326, AL21135, AJ07032, AL16093, AJ38251, AJ38252, AJ43300, OAK48341,
AJ23138, AJ25166, AL23145, AK39273, AJ30194, AK02009,
AJ24144, AJ32209, AL13073
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA,
Manufacturer: Applied
Cytometry, Sheffield, UK.
REASON Data generation
error: If the cytosettings is not refreshed or restarted during data
importation, the output will include old and new data.
VOLUME OF
PRODUCT IN COMMERCE 516 units nationwide; 73 units in
Canada
DISTRIBUTION Nationwide and Canada
PRODUCT Straumann
NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04,
Straumann,
CODE Lot Number:
G8677
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Straumann Usa, Llc, Andover, MA,
Manufacturer:
Instituit Strauman, Basel, Switzerland.
REASON Mislabeled package: Narrow Connection (NC)
Closure Screws contain closure screws for the regular connection (RC) bone level
implant. The RC closures screw is larger (3.5mm diameter) and therefore, will
not fit into the NC implant (3.0mm diameter) narrow
connection.
VOLUME OF PRODUCT IN COMMERCE 26
units
DISTRIBUTION Nationwide