SEPTEMBER 2007
WEEK ENDING SEPTEMBER 1
PRODUCT EasyLink
Informatics System, software version 3.0, Part Number 1000034941
CODE
Software version
3.0
RECALLING FIRM/MANUFACTURER Dade Behring, Inc.,
Newark, DE
REASON Sample ID and Patient results could be
associated with the wrong patient.
VOLUME OF PRODUCT IN
COMMERCE 72 units
DISTRIBUTION Nationwide
and
Belgium
PRODUCT
a) PhaSeal, Protector 14, Item No. P14, US Order No. 21320,
b) PhaSeal Injector Luer Lock, Model Item N31, US Order No.
10310,
c) PhaSeal, Protector 21, Item No. P21, US Order
No. 22020,
d) PhaSeal, Protector 50, Item No. P50, US
Order No. 22050,
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carmel
Pharma, Inc., Columbus, OH,
Manufacturer:
Carmel Pharma Ab, Gotenburg, Sweden.
REASON Risk of Leakage. When the PhaSeal Protector and
Injector are used with drug vials with thick rubber stoppers which have a
concave upper surface and a flat bottom surface there is a potential for
leakage. These rubber stoppers are made of a harder rubber formulation and may
be more difficult to penetrate.
VOLUME OF PRODUCT IN
COMMERCE 6.1 million
DISTRIBUTION Nationwide
and
Canada
PRODUCT
a)
AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List
Number-7A73-01
b) AxSYM Quinidine Controls - are composed of 3 bottles of
controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low,
Control Medium, Control High) containing quinidine
prepared in human serum to yield the different concentration
ranges- Product List Number 7A73-10,
c) XSYSTEMS Quinidine Calibrators consists of six bottles of Cal
A-F (2.5 mL each). Product List Number-9506-01,
d) XSYSTEMS Quinidine Controls are composed of 3 bottles of
controls (AxSYM 8mL & XSYSTEM 2.5ml) containing
quinidine prepared in human serum to yield different
concentration ranges.-Product List Number 9506-10,
CODE
a) Lot # 44794Q100 Exp. Date:
08/09/2007 and
Lot # 47093Q100 Exp. Date:
10/10/2007;
b) Lot # 43273Q100 Exp. Date: 06/23/2007 and
Lot # 47028Q100 Exp. Date; 10/14/2007;
c) Lot #
42442Q100 Exp. Date: 07/17/2007,
Lot # 44791Q100 Exp.
Date: 10/09/2007,
Lot # 46753Q100 Exp. Date: 12/10/2007,
Lot # 48107Q100 Exp. Date: 10/09/2007,
Lot # 50236Q100 Exp. Date: 04/21/2008,
and Lot # 51591Q100 Exp. Date: 04/21/2008;
d) Lot #
44161Q100 Exp. Date: 08/23/2007,
Lot # 46295Q100 Exp.
Date: 8/23/2007,
Lot # 48239Q100 Exp. Date: 01/04/2008,
and Lot# 50238Q100 Exp. Date:
05/20/2008
RECALLING FIRM/MANUFACTURER Abbott Diagnostic
International, Ltd., Barceloneta, PR
REASON Controls Out of
Range/Specification.
VOLUME OF PRODUCT IN COMMERCE 719
DISTRIBUTION Nationwide and
Internationally
PRODUCT BacT/ALERT® FN Culture Bottles, Product Number 259793,
CODE
Lot: 1015145
RECALLING
FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC,
REASON Microbial Contamination: Bacillus sp.
contamination was detected in inoculated bottles.
VOLUME OF PRODUCT
IN COMMERCE 2,403 cases (100 bottles per
case)
DISTRIBUTION Nationwide and
Internationally
PRODUCT Amsco
Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm), Model #'s V-136H,
V-148H, V-160H, SV-148H, V-1264 & V-1263& SFPP Steam Sterilizer, Model
#'s P-148H & P-160H,
CODE
Lots:
B093934202, B093924204, B09324223, B093924225, B093924227, B093924229,
B093924233, B093924244, B093924246, B093924248, B093924250, B093924286,
B093924288, B093924296, B093924307, B093924309, B093924310, B093924434,
B093924476, B093927301, B093927302, B093927322, B300903936
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH
Manufacturer: Steris Mexico, Guadalupe, Mexico.
REASON
The cables
inside the pump conduit box may be exposed (not covered with wire nut and/or
electrical tape) that could cause a potential electrical shock hazard.
VOLUME OF PRODUCT IN COMMERCE 78
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Zimmer
Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370,
CODE
Lot: 2385941
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc.,
Warsaw, IN,
Manufacturer: Zimmer Gmbh, Winterthur, Switzerland.
REASON The package actually contains a
knee patellar implant.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION MD
PRODUCT ABL80
FLEX Analyzer, Model #393-839
CODE All analyzers produced between 10/26/06
to 3/15/07 are being recalled (serial code/lot code range of 300101 to
300517)
RECALLING FIRM/MANUFACTURER Sendx Medical Inc.,
Carlsbad, CA
REASON There have been reported experiences
where waste fluids have sprayed out from the waste drain at the front of the
ABL80 analyzer when excessive pressure builds within the waste line.
VOLUME OF PRODUCT IN COMMERCE 334
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Volcano
s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of
the CPU, control console, monitor, printer, and patient interface module (PIM).
Device listing A863634, part number 804200-100. monitor part number that is
being replaced: 90X0315A, CODE All
units shipped on or before November 2005
RECALLING
FIRM/MANUFACTURER Volcano Corporation, Rancho Cordova, CA
REASON
During emissions testing, it was
discovered that the product exceeds emissions limits for electromagnetic
compatibility.
VOLUME OF PRODUCT IN COMMERCE 383
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Polaris
Dx Diagnostic Catheter, for cardiac electrophysiology studies, Catalog Model
number/Product UPN number M0049663S0, CODE Batch numbers: 9535942, 9596195, 9618290
RECALLING FIRM/MANUFACTURER Boston Scientific, Corp.,
San Jose, CA
REASON Product is mislabeled as hexapolar (6
electrodes), but is actually quadripolar (4 electrodes).
VOLUME OF
PRODUCT IN COMMERCE 30 units
DISTRIBUTION FL
and
TN
PRODUCT Atkinson
Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The
product is sold in boxes that contain 10 needles each
CODE Lot number 700894M
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Alcon Research,
Ltd, Fort Worth, TX
Manufacturer: Alcon Manufacturing LTD, Sinking Spring, PA.
REASON
Mislabeled. Boxes
actually contained Tri-Fact needles.
VOLUME OF PRODUCT IN
COMMERCE 2 boxes
DISTRIBUTION CA
WEEK ENDING SEPTEMBER 8
PRODUCT Varian
On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed
Tomography. Medical Linear Accelerator,
CODE Serial numbers:
H070002-H072113
RECALLING FIRM/MANUFACTURER Varian
Medical Systems Inc, Palo Alto, CA
REASON Patient positioning
errors may occur because of mechanical variations during product
installation.
VOLUME OF PRODUCT IN COMMERCE 291
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Abbott CELL-DYN 3000 Hematology Analyzer, Model number
CELL-DYN 3000 CS: List Numbers 91323-01 and 91323-03,
CELL-DYN 3000 SL: List Numbers 91325-01 and 91325-03,
b) Abbott
CELL-DYN 3500 Hematology Analyzer, Model
number CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03, Model number
CELL-DYN 3500 SL, List
Numbers 91350-01 and 91350-03, 91350-01 1 EACH CD3500 SL
ANALYZE(1 EACH) 1.000 0031192P, 91350-03 1 EACH CD3500SL
ANAL-REF(1 EACH) 1.000 30336P96, 91350-03 1 EACH CD3500SL
ANAL-REF 1.000 32159P96 05/05/2000, 91340-03 1 EACH CD
3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000,
c) Abbott
CELL-DYN 3700 Hematology Analyzer, Model number CELL-DYN 3700 CS, List Numbers 02H30-01and 91340-02, all serial numbers
distributed on or before May 3, 2007. Model number CELL-DYN 3700 SL, List
Numbers 02H31-01 and 02H31-03, all serial numbers distributed on or before May
3, 2007: 02H30-01 EA CD3700 CS(EA) 1.000 20222AN 01/16/2004 0708421226 ZOR 1025,
02H31-01 EA CD3700 SL(EA) 1.000 21423AK 04/16/2003 0705836717 ZOR 1025, 02H31-01
EA CD3700 SL(EA) 1.000 20575AK 01/17/2001 0700657123 ZINS 1024, 02H30-01 EA
CD3700 CS(EA) 1.000 20088AN 11/14/2001 0701853939 ZINS 1024, 02H31-01 EA CD3700
SL(EA) 1.000 21086AK 04/02/2002 0702540521 ZINC 1024, 02H31-01 EA CD3700 SL
1.000 20158AK 01/20/2000 30001171534T2 NC 1024, 02H30-01 EA CD3700 CS 1.000
19966AN 03/17/2000 30003160556T2 NC 1024, 02H31-01 EA CD3700 SL 1.000 20210AK
02/15/2000 30002100642T2 NC 1024, 02H30-01 EA CD3700 CS(EA) 1.000 19999AN
11/20/2000 0700475941 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20333AK
05/30/2000 0700023564 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21162AK
05/29/2002 0702793182 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20662AK
10/09/2001 0701535236 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21151K
04/26/2002 0702654355 ZINC 1024, 02H31-01 EA CD3700 SL 1.000 20215AK 02/23/2000
30002110316T2 NC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/29/2000
0700519556 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/29/2000
0700519556 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21526AK 08/22/2003
0707048787 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21195AK 05/29/2002
0702793121 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21193AK 05/29/2002
0702759492 ZOR 1025, 02H30-01 EA CD3700 CS 1.000 19953AN 01/21/2000
39912022083U3 SALE 1025 02H30-01 EA CD3700 CS 1.000 19966AN 03/08/2000
30002101167U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20210AK 01/27/2000
39912213420U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20215AK 01/27/2000
39912212921U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20333AK 05/18/2000
30004103499U2 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20565AK 11/29/2000
0700519549 ZINS 1024, 02H30-01 EA CD3700 CS 1.000 19953AN 01/27/2000
30001270601T2 NC 1024, 02H30-01 EA CD3700 CS(EA) 1.000 19999AN 10/31/2000
0700430444 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20088AN 10/25/2001
0701722636 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20106AN 02/14/2002
0702285397 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/30/2000
0700531142 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20565AK 11/30/2000
0700531141 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20574AK 12/01/2000
0700419159 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20575AK 12/01/2000
0700419161 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20576AK 12/01/2000
0700419160 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20662AK 03/08/2001
0700818411 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21086AK 03/01/2002
0702067225 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21151AK 04/22/2002
0702638488 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21162AK 04/26/2002
0702536142 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21508AK 08/18/2003
0706963179 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22038AK 03/10/2005
0721127803 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22039AK 03/10/2005
0721127803 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22035AK 03/08/2005
0721102104 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22041AK 03/10/2005
0721127061 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20576AK 01/17/2001
0700657124 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20574AK 11/29/2001
0701921151 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 22055AK 03/22/2005
0721231650 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21836AK 08/26/2004
0710348806 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20368AK 06/15/2000
0700067140 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20369AK 06/20/2000
0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20370AK 06/20/2000
0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20371AK 06/20/2000
0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20372AK 06/20/2000
0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20373AK 06/21/2000
0700067141 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20340AK 05/26/2000
0700022704 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20344AK 05/30/2000
0700022198 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20347AK 05/26/2000
0700022704 ZOR 1025, 02H30-01 EA CD3700 CS(EA) 1.000 20010AN 10/11/2000
0700390326 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20036AN 02/27/2001
0700702499 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20037AN 02/28/2001
0700665110 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20039AN 03/08/2001
0700764419 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20059AN 05/23/2001
0701034352 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20069AN 07/13/2001
0701274789 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20073AN 07/25/2001
0701296466 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20075AN 07/25/2001
0701296466 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20117AK96 03/12/2004
0708902744 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20154AK96 08/28/2006
0724669259 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20200AN 07/01/2003
0706596666 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20201AN 07/01/2003
0706596666 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20233AN 02/17/2004
0708707057 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20465AK96 09/29/2006
0724957687 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20645AK 02/27/2001
0700702498 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20646AK 02/27/2001
0700702498 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20700AK 03/29/2001
0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20703AK 03/29/2001
0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20704AK 03/29/2001
0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20705AK 03/29/2001
0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20707AK 03/30/2001
0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20708AK 03/29/2001
0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20710AK 03/30/2001
0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20711AK 03/30/2001
0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20712AK 03/30/2001
0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20716AK 03/30/2001
0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20742AK 04/24/2001
0700847325 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20869AK 08/06/2001
0701363650 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20870AK 08/07/2001
0701326067 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20871AK 08/07/2001
0701326067 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20877AK 08/14/2001
0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20881AK 08/14/2001
0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20882AK 08/14/2001
0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20883AK 08/15/2001
0701428194 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20884AK 08/15/2001
0701428194 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20885AK 08/16/2001
0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20886AK 08/16/2001
0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20887AK 08/16/2001
0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20888AK 08/16/2001
0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20889AK 08/17/2001
0701419778 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20891AK 08/21/2001
0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20892AK 08/21/2001
0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20893AK 08/21/2001
0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20894AK 08/23/2001
0701458396 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20896AK 08/28/2001
0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20897AK 08/23/2001
0701458396 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20898AK 08/23/2001
0701439537 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20902AK 08/28/2001
0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20903AK 08/29/2001
0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20904AK 08/28/2001
0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20905AK 08/28/2001
0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20907AK 08/28/2001
0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20908AK 08/31/2001
0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20909AK 08/29/2001
0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20910AK 08/29/2001
0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20911AK 08/29/2001
0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20912AK 08/29/2001
0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20913AK 08/31/2001
0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20914AK 08/31/2001
0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20915AK 08/31/2001
0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20917AK 08/31/2001
0701419777 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20940AK96 03/08/2004
0708891681 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20967AK 10/19/2001
0701730439 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20970AK 10/19/2001
0701730439 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20987AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20989AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20991AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20992AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20993AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20994AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20996AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20997AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20998AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20999AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21000AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21001AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21002AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21003AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21004AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21005AK 12/03/2001
0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21045AK 01/28/2002
0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21046AK 01/28/2002
0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21048AK 01/28/2002
0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21049AK 01/28/2002
0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21050AK 01/28/2002
0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21058AK 02/07/2002
0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21059AK 02/07/2002
0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21060AK 02/07/2002
0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21061AK 02/07/2002
0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21062AK 02/08/2002
0702270892 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21063AK 02/11/2002
0702277975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21064AK 02/08/2002
0702270892 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21065AK 02/13/2002
0702282548 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21067AK 02/11/2002
0702277975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21068AK 02/13/2002
0702282548 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21069AK 02/15/2002
0702299928 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21070AK 02/19/2002
0702311964 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21076AK 02/26/2002
0702357048 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21082AK 02/28/2002
0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21083AK 02/28/2002
0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21084AK 02/28/2002
0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21089AK 03/07/2002
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0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21091AK 03/08/2002
0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21092AK 03/08/2002
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0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21096AK 03/12/2002
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0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21098AK 03/13/2002
0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21099AK 03/12/2002
0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21100AK 03/14/2002
0702409791 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21101AK 03/13/2002
0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21102AK 03/13/2002
0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21103AK 03/19/2002
0702409792 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21104AK 03/14/2002
0702409791 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21105AK 03/19/2002
0702409792 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21107AK 03/19/2002
0702409792 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21127AK96 02/27/2004
0708817941 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21163AK 04/25/2002
0702452514 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21180AK 05/09/2002
0702726859 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21181AK 05/10/2002
0702726862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21182AK 05/09/2002
0702726859 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21183AK 05/10/2002
0702726862 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21244AK96 08/28/2006
0724669259 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21245AK96 08/17/2006
0724616503 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21473AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21474AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21475AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21476AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21478AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21479AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21480AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21481AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21482AK 07/01/2003
0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21483AK 07/01/2003
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0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21590AK 11/20/2003
0707872598 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21592AK 11/20/2003
0707872598 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21624AK 01/21/2004
0708229861 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21625AK 01/21/2004
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0708229862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21629AK 01/26/2004
0708230220 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21630AK 01/27/2004
0708520940 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21639AK 02/05/2004
0708585282 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21640AK 02/05/2004
0708585282 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21643AK 02/10/2004
0708585283 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21644AK 02/12/2004
0708585284 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21645AK 02/10/2004
0708585283 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21647AK 02/17/2004
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0708707082 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21651AK 02/24/2004
0708707083 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21652AK 02/23/2004
0708707082 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21654AK 03/04/2004
0708707085 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21655AK 03/04/2004
0708707085 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21656AK 03/04/2004
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0708707086 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21658AK 03/04/2004
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0708707098 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21839AK 08/26/2004
0710361988 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21841AK 08/26/2004
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0720995106 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22111AK 04/13/2005
0721376532 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22113AK 06/02/2005
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0721693890 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22119AK 06/02/2005
0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22138AK 06/02/2005
0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22154AK 06/02/2005
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0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22184AK 07/27/2005
0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22186AK 08/01/2005
0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22187AK 08/01/2005
0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22200AK 08/01/2005
0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22201AK 08/01/2005
0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22215AK 07/27/2005
0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22217AK 07/27/2005
0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22218AK 07/27/2005
0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22220AK 09/09/2005
0722368703 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22221AK 09/09/2005
0722368703 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22233AK 09/08/2005
0722353178 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22260AK 10/12/2005
0722601656 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22261AK 10/12/2005
0722601656 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22287AK 11/10/2005
0722807036 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22303AK 02/02/2006
0723378074 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22318AK 12/20/2005
0723075608 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22341AK 01/18/2006
0723279431 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22357AK 03/03/2006
0723573497 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22385AK 02/02/2006
0723378074 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22404AK 03/24/2006
0723666112 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22486AK 06/08/2006
0724084813 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22518AK 06/27/2006
0724306909 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22579AK 08/14/2006
0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22581AK 08/14/2006
0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22582AK 08/14/2006
0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22584AK 08/14/2006
0724381933 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22586AK 08/16/2006
0724600552 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22606AK 08/31/2006
0724658143 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22610AK 09/11/2006
0724831647 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22618AK 09/11/2006
0724794142 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22645AK 10/09/2006
0725013284 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20407AK 07/18/2000
0700159975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20409AK 07/18/2000
0700159975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20414AK 07/24/2000
0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20415AK 07/24/2000
0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20417AK 07/24/2000
0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20418AK 07/24/2000
0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20419AK 07/25/2000
0700179062 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20435AK 08/07/2000
0700214053 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20438AK 08/09/2000
0700214054 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20474AK 09/11/2000
0700242470 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20478AK 09/21/2000
0700242471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20480AK 09/21/2000
0700242471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20484AK 09/21/2000
0700242472 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20487AK 09/21/2000
0700242472 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20516AK 10/11/2000
0700308524 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20518AK 10/13/2000
0700242473 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20527AK 10/19/2000
0700242474 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20528AK 10/19/2000
0700242474 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20531AK 10/24/2000
0700242475 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20533AK 10/24/2000
0700242475 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20555AK 11/14/2000
0700242476 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20556AK 11/15/2000
0700488515 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20607AK 01/22/2001
0700242477 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20609AK 01/23/2001
0700668678 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20619AK 02/06/2001
0700311274 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20620AK 02/06/2001
0700242478 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20621AK 02/06/2001
0700311274 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20623AK 02/06/2001
0700242478 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20642AK 02/27/2001
0700399168 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20653AK 02/28/2001
0700311275 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20684AK 03/20/2001
0700311276 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20687AK 03/20/2001
0700764417 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20688AK 03/20/2001
0700311276 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20691AK 03/22/2001
0700311277 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20692AK 03/22/2001
0700311277 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20698AK 03/27/2001
0700311278 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20702AK 03/27/2001
0700311278 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20366AK 06/15/2000
0700067139 ZOR 1025, 02H30-01 EA CD3700 CS 1.000 19954AN 01/19/2000
30001052430U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20201AK 01/19/2000
30001052492U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20202AK 01/19/2000
30001052475U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20222AK 02/07/2000
30001272996U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20227AK 02/10/2000
30001272997U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20228AK 02/10/2000
30001272998U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20230AK 02/15/2000
30002100624U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20232AK 02/15/2000
30002100624U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20237AK 02/18/2000
30001273000U3 SALE 1025, 02H31-01 EA CD3700 SL 1.000 20239AK 02/18/2000
30001272999U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20242AK 02/28/2000
30001273003U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20243AK 02/22/2000
30001273001U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20246AK 02/23/2000
30001273002U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20280AK 03/30/2000
30003070642U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20285AK 03/31/2000
30003070647U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20286AK 03/31/2000
30003070652U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20296AK 04/13/2000
30003070646U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20298AK 04/13/2000
30003070659U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20306AK 04/21/2000
30004112193U3 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22669AK 01/24/2007
0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22711AK 01/24/2007
0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22725AK 01/24/2007
0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22746AK 03/08/2007
0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22747AK 03/19/2007
0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22748AK 03/08/2007
0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22750AK 03/19/2007
0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22758AK 03/19/2007
0725947869 ZOR 1025, 02H31-01 EA CD3700 SL 1.000 20239AK 02/18/2000
30001272999U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20242AK 02/28/2000
30001273003U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20243AK 02/22/2000
30001273001U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20246AK 02/23/2000
30001273002U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20280AK 03/30/2000
30003070642U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20285AK 03/31/2000
30003070647U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20286AK 03/31/2000
30003070652U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20296AK 04/13/2000
30003070646U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20298AK 04/13/2000
30003070659U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20306AK 04/21/2000
30004112193U3 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22669AK 01/24/2007
0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22711AK 01/24/2007
0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22725AK 01/24/2007
0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22746AK 03/08/2007
0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22747AK 03/19/2007
0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22748AK 03/08/2007
0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22750AK 03/19/2007
0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22758AK 03/19/2007
0725947869 ZOR 1025,
CODE All serial
numbers distributed before May 3, 2007.
RECALLING
FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA
REASON
The product failed electrostatic
discharge testing, which could result in product failure.
VOLUME OF
PRODUCT IN COMMERCE 3,429 total
units
DISTRIBUTION Nationwide and Internationally
PRODUCT ABL8O
FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number
914863
CODE Lot numbers: 17293,
17384, 17440, 17515, 17572 and 17663
RECALLING
FIRM/MANUFACTURER Sendx Medical Inc., Carlsbad, CA
REASON The ABL8O FLEX software version 1.10 contains
errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox).
These incorrect calculations result in a mild to moderate lowering of the base
excess value, the severity depending on the concentration of hemoglobin and the
oxygen saturation in the sample. Elevated hemoglobin concentrations have the
greatest impact on this calculation error.
VOLUME OF PRODUCT IN
COMMERCE 165 CDs
DISTRIBUTION Nationwide and
Internationally
PRODUCT Abbott
AxSYM System Digoxin III Reagent Pack
CODE Lot # 42740Q100 Exp Date: 05/11/07 Lot #
46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date:
05/11/07
RECALLING FIRM/MANUFACTURER Abbott Diagnostic
International, Ltd, Barceloneta, PR
REASON Customers are
receiving error codes (1062, 1063, 1113, & 1118) when running patient
samples on the AxSYM Digoxin III assay.
VOLUME OF PRODUCT IN
COMMERCE 2,579 kits
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a) Assorted sterile surgical kits/ trays:
DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in
Mexico;
DeRoyal D/C LEEPS, Hysteroscopes 80015, REF
89-4915.02, sterile, Rx only, assembled in Mexico;
DeRoyal ACF Tray, REF 50-11919.13, sterile, Rx only,
assembled in Mexico;
DeRoyal Ortho III, REF 89-2761.04,
sterile, Rx only, assembled in Mexico;
DeRoyal Shoulder
Tray, REF 89-3948.05, sterile, Rx only;
DeRoyal Cath Lab
Tray, REF 89-4100.03, sterile, Rx only;
DeRoyal Total
Knee Tray, REF 89-4191.06, sterile, Rx only;
DeRoyal LAP
Chole Tray Piggyback, REF 89-4017.05, sterile, Rx only;
DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, sterile, Rx only;
DeRoyal Thoracotomy Tray, REF 89-4199.06, sterile, Rx
only;
DeRoyal LAP GYN, REF 89-2995.07, sterile, Rx only;
DeRoyal Extremity Pack, REF 89-3068.11, sterile, Rx only;
DeRoyal Head and Neck Tray, REF 89-3281.04, sterile, Rx
only;
DeRoyal Sinus Tray, REF 89-3952.03, sterile, Rx
only, DeRoyal;
DeRoyal Arthroscopy, REF 89-4052.03,
sterile, Rx only;
DeRoyal Arthroscopy Tray, REF
89-4138.02, sterile, Rx only;
DeRoyal Plastics Tray, REF
89-4197.04, sterile, Rx only;
DeRoyal Laparotomy Pack, REF
89-4312.04, sterile, Rx only;
DeRoyal OR Tray, REF
89-4422.02, sterile, Rx only;
DeRoyal Breast Augmentation
Pack, REF 89-4447.03, sterile, Rx only;
DeRoyal ORTHO
Pack, REF 89-4482.03, sterile, Rx only;
DeRoyal Major
Joint Tray, REF 89-4613.06, sterile, Rx only;
DeRoyal Hip
Joint Tray, REF 89-4614.05, sterile, Rx only;
DeRoyal
Podiatry Tray, REF 89-4976.02, sterile, Rx only;
DeRoyal
Extremity Tray, REF 94-0148.03, sterile, Rx only;
DeRoyal
Arthroscopy Tray, REF 89-4998.03, sterile, Rx only;
DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, sterile, Rx only;
DeRoyal Lap Banding Pack, REF 89-5693.01, sterile, Rx
only;
DeRoyal C-Section Pack, REF 89-5703.01, sterile, Rx
only;
DeRoyal Shoulder Pack, REF
89-5715.01, sterile, Rx only;
DeRoyal C/V Pack Tray, REF
20-011700.12, sterile, Rx only;
DeRoyal Heart Pack, REF
20-12059.16A, sterile, Rx only;
DeRoyal Arthroscopy Tray,
REF 89-3146.06, sterile, Rx only;
DeRoyal Pacemaker, REF
89-4024.06, sterile, Rx only;
DeRoyal Major Lithotomy
Tray, REF 89-4193.05, sterile, Rx only;
DeRoyal
Angiography Drape Pack, REF 89-4278.05, sterile, Rx only;
DeRoyal Minor General Pack, REF 89-4289.05, sterile, Rx only;
DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A,
sterile, Rx only;
DeRoyal Total Knee Tray, REF
50-12456.07, sterile, Rx only;
DeRoyal Extremity Tray,
REF 89-4697.03, sterile, Rx only;
DeRoyal C-Section Pack,
REF 50-13134.08, sterile, Rx only;
DeRoyal Major Vascular
Tray, REF 89-3561.06, sterile, Rx only;
DeRoyal LAP
Hernia/Band Tray, REF 89-5707.01, sterile, Rx only;
DeRoyal C-Section Pack, REF 50-13134.09, Rx only;
DeRoyal
Ortho Basic Tray, REF 89-2650.14, sterile, Rx only;
DeRoyal Head/Neck Pack, REF 89-5736.01, exp. 2012-04, sterile, Rx only;
DeRoyal Major Pack, REF 50-12783.06, sterile, Rx only;
DeRoyal AAA Tray, REF
89-3453.05 A, sterile, Rx only,
DeRoyal AAA Tray, REF
89-3453.05 B, sterile, Rx only;
DeRoyal Foot Pack, REF
89-5713.01, sterile, Rx only;
DeRoyal Cardiac Cath Tray,
REF 50-13027.16, sterile, Rx only;
DeRoyal PEDS Accessory
Tray, REF 50-13017.16, sterile, Rx only;
DeRoyal Head and
Neck Tray, REF 50-7738.18, sterile, Rx only;
DeRoyal
Spine Tray II Pgybk, REF 89-3792.04 A, sterile, Rx only;
DeRoyal Spine Tray II Pgybk, REF 89-3792.04 B, sterile, Rx only;
DeRoyal C-Section Tray, REF 94-0007.08, Rx
only;
DeRoyal Open Heart Tray, REF 89-4196.10 A, sterile,
Rx only;
DeRoyal Open Heart Tray, REF 89-4196.10 B,
sterile, Rx only;
DeRoyal Open Heart Tray, REF
89-4196.10 S, sterile, Rx only;
DeRoyal Shoulder Tray, REF
89-4184.05, sterile, Rx only;
DeRoyal Cysto Tray, REF
89-3251.07, sterile, Rx only;
DeRoyal C-Section Tray, REF
89-3619.04, sterile, Rx only;
DeRoyal Shoulder
Tray, REF 89-3948.05, sterile, Rx only;
DeRoyal
Hand/Foot Tray, REF 89-4181.06, sterile, Rx only;
DeRoyal
Major Pack, REF 89-4251.03, sterile, Rx only;
DeRoyal
Knee Arthroscopy Pack, REF 89-4307.05, sterile, Rx only;
DeRoyal LAP Chole Tray, REF 89-4342.02, sterile, Rx only;
DeRoyal Shoulder Arthroscopy, REF 89-4453.02, sterile, Rx only;
DeRoyal Radical Prost Tray
Pgybk, REF 89-4558.03, sterile, Rx only,
DeRoyal General Pack, REF 89-5231.03, sterile, Rx only;
DeRoyal Knee Arthroscopy Pack, REF 89-5295.01, sterile,
Rx only;
DeRoyal Thoracotomy Tray, REF 50-8130.09,
sterile, Rx only;
DeRoyal JIT C-Section Pack, REF
89-2572.06, sterile, Rx only;
DeRoyal C-Section w/Pouch
Drape, REF 89-3435.02, sterile, Rx only;
DeRoyal LAP
Chole Tray, REF 50-11064.09, sterile, Rx only;
DeRoyal
Open Heart Tray II, REF 89-3181.05, sterile, Rx only;
DeRoyal Carotid/AV Fistula Tray, REF 89-3712.02, sterile, Rx only;
DeRoyal Open Heart Tray, REF 50-4504.14, sterile, Rx
only;
DeRoyal LAP Chole Tray, REF 50-12788.08, sterile,
Rx only;
DeRoyal Carotid Tray, REF 50-7650.22, sterile,
Rx only;
DeRoyal General/Plastic Tray Standard, REF
89-5031.01, sterile, Rx only;
DeRoyal Cataract Tray, REF
50-12183.07, sterile, Rx only;
DeRoyal Cath Lab Tray, REF
50-12050.11, sterile, Rx only;
DeRoyal Ear Tray, REF
50-3028.18, sterile, Rx only;
DeRoyal All Service Basic,
REF 89-2651.09, sterile, Rx only;
DeRoyal CV Drape Pack,
REF 89-5137.01, sterile, Rx only;
DeRoyal Extremity Tray,
REF 89-5164.02, sterile, Rx only;
DeRoyal Shoulder
Arthroscopy, REF 89-5258.05, sterile, Rx only;
DeRoyal C
Section Tray Pgybk, REF 94-0101.08, sterile, Rx only;
DeRoyal Cysto Tray, REF 89-3251.07, sterile, Rx only;
DeRoyal Liposuction Tray, REF 89-3763.02, sterile, Rx only;
DeRoyal Foot Pack Pgybk, REF 89-3794.07 A, sterile, Rx
only;
DeRoyal Shoulder Pack, REF 89-5725.01, , Rx only;
DeRoyal Open Heart Tray I, REF 89-3182.05, sterile, Rx
only;
DeRoyal Arteriogram Tray, REF 50-12994.14, sterile,
Rx only;
DeRoyal Total Hip, REF 50-13535.08,
sterile, Rx only;
DeRoyal Basic
Pack, REF 89-2746.03, sterile, Rx only;
DeRoyal
Arthroscopy Tray, REF 89-3645.03, sterile, Rx only;
DeRoyal C-Section Pack, REF 89-2310.02, sterile, Rx only;
DeRoyal Total Knee Tray, REF 89-3987.04, sterile, Rx only;
DeRoyal Podiatry Tray Pgybk, REF 50-9406.16, sterile, Rx
only;
DeRoyal Basic Endo Tray, REF 89-3456.04, sterile,
Rx only;
DeRoyal Minor Tray, REF 89-3823.13, sterile, Rx
only;
DeRoyal Shoulder Pack, REF 89-5154.01, sterile, Rx
only;
DeRoyal LAP Chole Tray, REF 89-5291.01, sterile, Rx
only;
DeRoyal Hand Pack, REF 89-5810.01, sterile, Rx
only9;
DeRoyal LAP Chole Tray, REF 50-11036.07, sterile,
Rx only;
DeRoyal CABG Pack, REF 50-13509.10, sterile, Rx
only;
DeRoyal Total Hip Basin Set, REF 89-1319.05,
sterile, Rx only;
DeRoyal Total Knee Basin Set, REF
89-1321.07, sterile, Rx only;
DeRoyal Total Hip, REF
89-2608.06, sterile, Rx only;
DeRoyal Angiography Tray,
REF 89-3558.07, sterile, Rx only;
DeRoyal Abdohyst, Lapaexpl, REF 89-2497.12, sterile, Rx only;
DeRoyal
General Surgery Tray, REF 89-4094.02, sterile, Rx only;
DeRoyal Neuro/Spine Basin Pack, REF 89-5717.01, sterile, Rx only;
DeRoyal TAH Tray, REF 89-2672.09, sterile, Rx only;
DeRoyal LAP Hernia Tray, REF 89-3468.04, sterile, Rx
only;
DeRoyal C-Section Tray 3/Case, REF 50-2688.19,
sterile, Rx only;
DeRoyal Peripheral Vascular
Tray, REF 89-3874.05, sterile, Rx only;
DeRoyal Major
Abdominal Tray, REF 89-4155.04, sterile, Rx only;
DeRoyal
Open Heart Pack, REF 89-5339.02 A, sterile, Rx only;
DeRoyal Open Heart Pack, REF 89-5339.02 B, sterile, Rx only;
DeRoyal LAP Chole Tray, REF 50-12892, sterile, Rx
only;
DeRoyal Auxilary Towel Pack, REF 50-12925.11,
sterile, Rx only;
DeRoyal Fayette Arthroscopy Tray, REF
50-12975.06, sterile, Rx only;
DeRoyal Craniotomy Tray,
REF 89-3563.11, sterile, Rx only;
DeRoyal O.R. Basin Tray
4/CS, REF 50-3482.22, sterile, Rx only;
DeRoyal Basic
Set, REF 89-3514.05, sterile, Rx only;
DeRoyal C-Section
Tray, REF 89-4849.02, sterile, Rx only;
DeRoyal
Arthroscopy Tray, REF 89-3188.07, sterile, Rx only;
DeRoyal Major Vascular Tray, REF 89-3561.07, sterile, Rx only;
DeRoyal Basic Pack, REF 89-4101.06, sterile, Rx only;
DeRoyal Basic Extremity Pack, REF
89-4309.05, sterile, Rx only;
DeRoyal Minor Joint Tray,
REF 89-4615.05, sterile, Rx only;
DeRoyal Shoulder
Arthroscopy Pack, REF 89-4974.03, sterile, Rx only;
DeRoyal Basic Set, REF 94-0146.05, sterile, Rx only;
DeRoyal C-Section Pack, REF
50-12111.02, sterile, Rx only;
DeRoyal Upper Extremity
Value Set, REF 89-4426.04, sterile, Rx only;
DeRoyal
Laparotomy Pack, REF 50-12471.07, sterile, Rx only;
DeRoyal Podiatry Tray, REF 50-835.06, sterile, Rx only;
DeRoyal Basic Cath Tray, REF 89-4173.05,
sterile, Rx only;
DeRoyal Cardiac Cath Tray, REF
50-13119.19, sterile, Rx only;
DeRoyal Limb Pack, REF
50-3836.23, sterile, Rx only;
DeRoyal Extremity Tray, REF
89-5113.05, sterile, Rx only;
DeRoyal Basic Pack, REF
89-5798.01, sterile, Rx only;
DeRoyal
Pacemaker Tray, REF 89-3727.06, sterile, Rx only;
DeRoyal
Kellog Back Pack, REF 89-5817.01, sterile, Rx only;
DeRoyal Basic Pack, REF 89-5155.02, sterile, Rx only
DeRoyal Abdominalplasty Tray, REF 89-5677.01, sterile, Rx only;
DeRoyal Extremity Pack, REF 89-5812.01, sterile, Rx only;
DeRoyal General Orthopedic Tray, REF 89-2851.06, sterile,
Rx only;
DeRoyal Total Hip Pack, REF 89-3876.03, sterile,
Rx only;
DeRoyal LAMI Pack, REF 89-4114.03, sterile, Rx
only;
DeRoyal Podiatry Tray, REF 50-13341.04, sterile, Rx
only;
DeRoyal Total Knee Tray, REF 89-3288.04, sterile,
Rx only;
DeRoyal Basic LAP Tray, REF 89-3297.06, sterile,
Rx only;
DeRoyal Radical Prost Tray Pgybk, REF
89-4558.03, sterile, Rx only;
DeRoyal NW ASC Shoulder Arthro, REF 89-4569.07, sterile, Rx only;
DeRoyal TVT
Pack, REF 89-5782.01, sterile, Rx only;
DeRoyal Double
Basin Set, REF 89-0191.05, sterile, Rx only;
DeRoyal
Vascular AV Fistula Pack, REF 50-8118.08, sterile, Rx only;
DeRoyal Arthroscopy Pack, REF 50-12988.10, sterile, Rx
only;
DeRoyal Gyn Laparoscopy, REF 89-2646.10, sterile,
Rx only;
DeRoyal Heart Tray, REF 89-3916.05 A, sterile,
Rx only;
DeRoyal Heart Tray, REF 89-3916.05 B, sterile,
Rx only;
DeRoyal Arthroscopy Tray, REF 89-5714.01,
sterile, Rx only;
DeRoyal Lumbar Disk, REF 89-3390.06,
sterile, Rx only;
DeRoyal Cath Lab Accessory Tray, REF
89-4023.07, sterile, Rx only;
DeRoyal Extremity Pack, REF
89-2565.08, sterile, Rx only;
DeRoyal Custom hand Tray,
REF 89-4593.03, sterile, Rx only;
DeRoyal Basic Major
Tray, REF 94-0283.11, sterile, Rx only;
DeRoyal Cardiac
Cath Lab Tray, REF 89-5109.01, sterile, Rx only;
DeRoyal
Open Heart Drape Pack, REF 89-5202.01, sterile, Rx only;
DeRoyal Total Hip A&B Pack Pgybk, REF
89-5285.01 A, sterile, Rx only;
DeRoyal Total Hip A&B
Pack Pgybk, REF 89-5285.01 B, sterile, Rx only;
DeRoyal
Clevens Facelift Pack, REF 89-5728.01, sterile, Rx only;
DeRoyal C-Section Tray, REF 50-12505.08, sterile, Rx only;
b) Assorted non- sterile Tracecarts (with sterile
component(s));
1) DeRoyal C-Section Tracecart, REF 53-1746.02,
non-sterile, Rx only;
2) DeRoyal CABG Tracepak, REF
90-2838.11, non-sterile, Rx only;
3) DeRoyal CABG
Tracecart, REF 53-1865.03, non-sterile, Rx only;
4)
DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, non-sterile, Rx only;
5) DeRoyal Neuro Tracecart, REF 53-1763.02, non-sterile,
Rx only;
6) DeRoyal Heart Tracecart, REF 53-1897.02, Rx
only;
7) DeRoyal LAP Chole Tracecart, REF 53-1862.03,
non-sterile, Rx only;
8) DeRoyal LAP Chole Tracepak, REF
90-2774.10, non-sterile, Rx only;
9) DeRoyal Total Knee
Tracecart, REF 53-1838.02, non-sterile, Rx only;
10)
DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, non-sterile, Rx only;
11) DeRoyal Heart Tracecart, REF 53-1725.13, non-sterile, Rx
only;
12) DeRoyal C-Section Tracecart, REF 53-1837.03,
non-sterile, Rx only;
13) DeRoyal C-Section Tracecart, REF
53-1781.04, non-sterile, Rx only;
14) DeRoyal Carotid/AV
Fistula Tracecart, REF 53-1760.03, non-sterile, Rx only;
15)
DeRoyal Neuro Tracecart, REF 53-1815.06, non-sterile, Rx only,
16) DeRoyal AAA Tracecart, REF 53-1765.08, non-sterile, Rx only;
17) DeRoyal LAP Chole Tracecart, REF 53-1767.08, non-sterile,
Rx only,
CODE
a) DeRoyal Neuro
Tray, REF 89-4502.05, Lots: 12319975, exp 2008-01 and
12521971, exp 2008-01,
DeRoyal Diskectomy Pack, REF
89-4504.03, Lots: 12319983, exp 2009-02 and 12521989, exp 2009-02;
Shoulder
Tray, REF 89-3948.05, Lot 12319595, exp 2012-04;
DeRoyal
Cath Lab Tray, REF 89-4100.03, Lots: 12219616, exp 2012-07 and 12519205, exp 2012-05;
DeRoyal
Total Knee Tray, REF 89-4191.06, Lot 12364881, exp 2009-02;
DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, Lot
12364899, exp 2011-10;
DeRoyal Knee Arthroscopy Tray, REF
89-4206.04, Lot 12364944, exp 2009-01;
DeRoyal Thoracotomy
Tray, REF 89-4199.06, Lot 12365082, exp 2011-01;
DeRoyal
D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, Lot 12365162, exp 2009-06;
DeRoyal ACF Tray, REF
50-11919.13, Lot 12365381, exp 2009-01;
DeRoyal Ortho III,
REF 89-2761.04, Lot 12365584, exp 2012-04;
DeRoyal LAP GYN, REF 89-2995.07, Lot 12365681, exp 2010-03;
DeRoyal
Extremity Pack, REF 89-3068.11, Lot 12365728, exp 2012-01;
DeRoyal Head and Neck Tray, REF 89-3281.04, Lot 12365939,
exp 2012-04;
DeRoyal Sinus Tray, REF 89-3952.03, Lot
12366270, exp 2011-10;
DeRoyal Arthroscopy, REF
89-4052.03, Lot 12366341, exp 2011-01;
DeRoyal
Arthroscopy Tray, REF 89-4138.02, Lot 12366448, exp 2010-01;
DeRoyal Plastics Tray, REF 89-4197.04, Lot 12366544, exp
2011-071;
DeRoyal Laparotomy Pack, REF 89-4312.04, Lot
12366632, exp 2009-02;
DeRoyal OR Tray, REF 89-4422.02,
Lot 12366755, exp 2012-04;
DeRoyal Breast Augmentation
Pack, REF 89-4447.03, Lot 12366801, exp 2010-01,
DeRoyal ORTHO Pack, REF 89-4482.03, Lot
12366923, exp 2008-02;
DeRoyal Major Joint Tray, REF
89-4613.06, Lot 12367205, exp 2012-03;
DeRoyal Hip Joint
Tray, REF 89-4614.05, Lot 12367192, exp 2012-03;
DeRoyal
Podiatry Tray, REF 89-4976.02, Lot 12367344, exp 2011-12;
DeRoyal Extremity Tray, REF 94-0148.03, Lot 12367408, exp 2012-04;
DeRoyal Arthroscopy Tray, REF 89-4998.03, Lot 12367521,
exp 2010-02;
DeRoyal Shoulder Arthroscopy Tray, REF
89-5678.01, Lot 12368259, exp 2012-02;
DeRoyal Lap Banding Pack, REF
89-5693.01, Lots: 12368304, exp 2010-01 and
12580436, exp 2010-01;
DeRoyal C-Section Pack, REF
89-5703.01, Lot 12368380, exp 2010-02;
DeRoyal Shoulder
Pack, REF 89-5715.01, Lot 12368460, exp 2012-04;
DeRoyal
C/V Pack Tray, REF 20-011700.12, Lot 12368654, exp 2011-10;
DeRoyal Heart Pack, REF 20-12059.16A, Lot 12368726, exp 2009-01;
DeRoyal Arthroscopy Tray, REF 89-3146.06, Lot 12332598,
exp 2010-01;
DeRoyal Pacemaker, REF 89-4024.06, Lot
12332871, exp 2008-07;
DeRoyal Major Lithotomy Tray, REF
89-4193.05, Lot 12332951, exp 2009-04;
DeRoyal Angiography Drape Pack, REF 89-4278.05, Lot 12332993, exp
2008-12;
DeRoyal Minor General Pack, REF
89-4289.05, Lot 12333005, exp 2012-04;
DeRoyal Back Table
Set Up - Knee, REF 50-11617.07 A, Lot 12334155,
exp
2010-02;
DeRoyal Total Knee Tray, REF 50-12456.07, Lot
12345743, exp 2009-01;
DeRoyal Extremity Tray, REF
89-4697.03, Lot 12428901, exp 2010-01;
DeRoyal C-Section
Pack, REF 50-13134.08, Lot 12345786, exp 2011-09;
DeRoyal
Major Vascular Tray, REF 89-3561.06, Lot 12346308, exp
2009-01;
DeRoyal LAP Hernia/Band Tray, REF 89-5707.01,
Lots: 12332598, exp 2012-01
and 12580532, exp.
2011-11;
DeRoyal C-Section Pack, REF 50-13134.09, Lot
12428987, exp 2011-12;
DeRoyal Ortho Basic Tray, REF
89-2650.14, Lot 12429040, exp 2012-04;
DeRoyal Head/Neck
Pack, REF 89-5736.01, Lots: 12430307, exp 2012-04 and
12475708, exp. 2012-04;
DeRoyal
Major Pack, REF 50-12783.06, Lot 12323683, exp 2011-04;
DeRoyal AAA Tray, REF 89-3453.05 A, Lots: 12324310, exp 2009-12 and 12572647, exp 2010-02;
DeRoyal AAA
Tray, REF 89-3453.05 B, Lot 12572647, exp 2010-02;
DeRoyal
Foot Pack, REF 89-5713.01, Lot 12429963, exp 2010-01;
DeRoyal Cardiac Cath Tray, REF 50-13027.16, Lot 12274383, exp
2008-12;
DeRoyal Dr. D. C. Pack, REF 50-8858.24, Lots:
12242699, exp 2012-03 and
12384540, exp
2012-04;
DeRoyal PEDS Accessory Tray, REF 50-13017.16, Lot
12458553, exp 2010-01;
DeRoyal Head and Neck Tray, REF
50-7738.18, Lot 12411413, exp 2009-02;
DeRoyal Spine Tray
II Pgybk, REF 89-3792.04 A, Lot 12411552, exp 2009-01;
DeRoyal Spine Tray II Pgybk, REF 89-3792.04 B, Lot 12411552, exp
2009-01;
DeRoyal C-Section Tray, REF 94-0007.08, Lot
12411886, exp 2009-01;
DeRoyal Open Heart Tray, REF
89-4196.10 A, Lot 12411958, exp 2009-10;
DeRoyal Open
Heart Tray, REF 89-4196.10 B, Lot 12411958, exp 2009-10;
DeRoyal Open Heart Tray, REF 89-4196.10 S, Lot 12411958, exp
2009-10;
DeRoyal Shoulder Tray, REF 89-4184.05, Lot
12411991, exp 2009-03;
DeRoyal Cysto Tray, REF 89-3251.07,
Lot 12412441, exp 2009-11;
DeRoyal C-Section Tray, REF
89-3619.04, Lot 12412539, exp 2009-12;
DeRoyal Shoulder
Tray, REF 89-3948.05, Lot 12412643, exp 2012-04;
DeRoyal Hand/Foot Tray, REF
89-4181.06, Lot 12412782, exp 2011-07;
DeRoyal Major Pack,
REF 89-4251.03, Lot 12412926, exp 2009-03;
DeRoyal Knee
Arthroscopy Pack, REF 89-4307.05, Lot 12412942, exp 2012-01;
DeRoyal LAP Chole Tray, REF 89-4342.02,
Lot 12412951, exp 2011-10;
DeRoyal Shoulder Arthroscopy,
REF 89-4453.02, Lot 12412993, exp 2012-01;
DeRoyal Radical
Prost Tray Pgybk, REF 89-4558.03, Lot 12413099, exp 2009-03;
DeRoyal General Pack, REF 89-5231.03, Lot 12413355, exp
2012-01;
DeRoyal, Powell, TN 37849 DeRoyal Knee
Arthroscopy Pack, REF 89-5295.01,
Lot 12413443, exp
2010-01;
DeRoyal Thoracotomy Tray, REF 50-8130.09, Lot
12414227, exp 2009-03;
DeRoyal JIT C-Section Pack, REF
89-2572.06, Lot 12586395, exp 2008-09;
DeRoyal C-Section
w/Pouch Drape, REF 89-3435.02, Lot 12403616, exp 2012-04;
DeRoyal LAP Chole Tray, REF
50-11064.09, Lot 12403878, exp 2011-12;
DeRoyal Open Heart
Tray II, REF 89-3181.05, Lot 12403915, exp 2010-03;
DeRoyal Carotid/AV Fistula Tray, REF 89-3712.02, Lots: 12404070, exp 2009-03,
12521946, exp 2008-12, 12459425, exp 2009-04;
DeRoyal Open Heart Tray, REF 50-4504.14, Lot 12383918,
exp 2011-07;
DeRoyal LAP Chole Tray, REF 50-12788.08, Lot
12383951, exp 2011-10;
DeRoyal Carotid Tray, REF
50-7650.22, Lot 12384013, exp 2009-02;
DeRoyal
General/Plastic Tray Standard, REF 89-5031.01, Lot 12384030, exp 2010-01;
DeRoyal Cataract Tray,
REF 50-12183.07, Lot 12384072, exp 2010-03;
DeRoyal Cath
Lab Tray, REF 50-12050.11, Lot 12404070, exp 2009-12;
DeRoyal Ear Tray, REF 50-3028.18, Lot 12384435, exp
2012-04;
DeRoyal All Service Basic, REF 89-2651.09, Lot
12384831, exp 2012-04;
DeRoyal CV Drape Pack, REF
89-5137.01, Lot 12385024, exp 2012-04;
DeRoyal Extremity
Tray, REF 89-5164.02, Lot 12385032, exp 2011-08;
DeRoyal
Shoulder Arthroscopy, REF 89-5258.05, Lots: 12385083,
exp
2010-01 and 12454739, exp. 2010-01;
DeRoyal C Section Tray
Pgybk, REF 94-0101.08, Lot 12355044, exp 2008-11;
DeRoyal
Cysto Tray, REF 89-3251.07, Lot 12355247, exp 2009-11;
DeRoyal Liposuction Tray, REF 89-3763.02, Lot 12355271, exp
2012-04;
DeRoyal Foot Pack Pgybk, REF 89-3794.07 A, Lot
12355343, exp 2009-03;
DeRoyal Shoulder Pack, REF
89-5725.01, Lot 12358149, exp 2010-03, sterile;
DeRoyal
Open Heart Tray I, REF 89-3182.05, Lot 12411958, exp
2011-10;
DeRoyal Endo Tray, REF 89-3462.06, Lots:
12358350, exp 2009-01 and 12459353, exp 2009-03;
DeRoyal Arteriogram Tray, REF 50-12994.14, Lots:
12364354, exp 2011-11 and 12555935, exp. 2012-01;
DeRoyal Total Hip, REF 50-13535.08, Lot 12364362, exp
2009-01;
DeRoyal Basic Pack, REF 89-2746.03, Lot
12364573, exp 2012-04;
DeRoyal Arthroscopy Tray, REF
89-3645.03, Lot 12364821, exp 2009-01;
DeRoyal Dr. K.
Tray, REF 89-4004.05, Lot 12364872, exp 2010-02;
DeRoyal
C-Section Pack, REF 89-2310.02, Lot 12538617, exp 2008-12;
DeRoyal Total Knee Tray, REF 89-3987.04, Lot 12519150, exp 2009-03;
DeRoyal Podiatry Tray Pgybk, REF 50-9406.16, Lot
12519176, exp 2011-11;
DeRoyal Basic Endo Tray, REF
89-3456.04, Lots: 12459409, exp 2009-02 and 12521866, exp
2009-02;
DeRoyal Minor Tray, REF 89-3823.13, Lot 12587742,
exp 2011-10;
DeRoyal Shoulder Pack, REF 89-5154.01, Lot
12588323, exp 2012-01;
DeRoyal LAP Chole Tray, REF
89-5291.01, Lot 12588462, exp 2010-01;
DeRoyal Hand Pack,
REF 89-5810.01, Lot 12589019, exp 2010-01;
DeRoyal LAP
Chole Tray, REF 50-11036.07, Lot 12589060, exp 2011-11;
DeRoyal CABG Pack, REF 50-13509.10, Lot 12589107, exp
2008-10;
DeRoyal Total Hip Basin Set, REF 89-1319.05,
Lots: 12589158, exp 2009-02
and 12459311, exp
2009-02;
DeRoyal Total Knee Basin Set, REF 89-1321.07,
Lots: 12589166, exp 2009-02
and 12628508, exp 2009-02;
DeRoyal Total Hip, REF 89-2608.06, Lot 12490799, exp
2012-03;
DeRoyal Angiography Tray, REF 89-3558.07, Lot
12490975, exp 2008-12;
DeRoyal Abdohyst, Lapaexpl, REF
89-2497.12, Lot 12491601, exp 2008-09;
DeRoyal General
Surgery Tray, REF 89-4094.02, Lot 12490975, exp 2012-02;
DeRoyal Neuro/Spine Basin Pack, REF 89-5717.01, Lot 12491994, exp
2011-10;
DeRoyal TAH Tray, REF
89-2672.09, Lot 12587523, exp 2010-02;
DeRoyal LAP Hernia
Tray, REF 89-3468.04, Lot 12459361, exp 2009-03;
DeRoyal
C-Section Tray 3/Case, REF 50-2688.19, Lot 12586512, exp
2012-05;
DeRoyal Peripheral Vascular Tray, REF 89-3874.05,
Lot 12586555, exp 2011-10;
DeRoyal Major Abdominal Tray,
REF 89-4155.04, Lot 12466107, exp 2011-11;
DeRoyal Open
Heart Pack, REF 89-5339.02 A, Lots: 12589326, exp 2009-01 and 12572727, exp 2009-01;
DeRoyal
Open Heart Pack, REF 89-5339.02 B, Lot 12572727, exp 2009-01;
DeRoyal LAP Chole Tray, REF 50-12892, Lot 12586889, exp
2009-02;
DeRoyal Auxilary Towel Pack, REF 50-12925.11, Lot
12586918, exp 2012-05;
DeRoyal Fayette Arthroscopy Tray,
REF 50-12975.06, Lots: 12586951, exp 2010-02 and
12429488, exp. 2010-02;
DeRoyal Craniotomy Tray, REF
89-3563.11, Lots: 12473315, exp 2008-11 and 12604848, exp
2010-01, sterile;
DeRoyal O.R. Basin Tray 4/CS, REF
50-3482.22, Lot 12473374, exp 2012-04;
DeRoyal Basic Set,
REF 89-3514.05, Lot 12473420, exp 2012-05;
DeRoyal
C-Section Tray, REF 89-4849.02, Lot 12473462, exp 2009-02;
DeRoyal Arthroscopy Tray, REF 89-3188.07, Lot 12474086, exp
2012-02;
DeRoyal Major Vascular Tray, REF 89-3561.07, Lot
12474211, exp 2009-02;
DeRoyal Basic Pack, REF 89-4101.06,
Lot 12474351, exp 2012-05;
DeRoyal Basic Extremity Pack,
REF 89-4309.05, Lot 12474529, exp 2011-11;
DeRoyal Minor
Joint Tray, REF 89-4615.05, Lot 12474756, exp 2011-08;
DeRoyal Shoulder Arthroscopy Pack, REF 89-4974.03, Lot 12474799, exp 2012-02;
DeRoyal Basic Set, REF
94-0146.05, Lots: 12474861, exp 2012-05 and 12579945, exp
2012-05;
DeRoyal C-Section Pack, REF 50-12111.02, Lot
12475767, exp 2012-04;
DeRoyal Upper Extremity Value Set,
REF 89-4426.04, Lot 12454667,
exp
2008-07;
DeRoyal Laparotomy Pack, REF 50-12471.07, Lot
12429402, exp 2012-04;
DeRoyal Podiatry Tray, REF
50-835.06, Lot 12429568, exp 2012-04;
DeRoyal Basic Cath
Tray, REF 89-4173.05, Lot 12429200, exp 2010-01;
DeRoyal
Cardiac Cath Tray, REF 50-13119.19, Lot 12429234, exp 2008-10;
DeRoyal Limb Pack, REF 50-3836.23, Lot 12429285, exp
2012-04;
DeRoyal Extremity Tray, REF 89-5113.05, Lot
12656023, exp 2012-05;
DeRoyal Basic Pack, REF
89-5798.01, Lot 12628268, exp 2012-03;
DeRoyal Pacemaker
Tray, REF 89-3727.06, Lot 12640110, exp 2012-05;
DeRoyal
Kellog Back Pack, REF 89-5817.01, Lot 12640523, exp 2009-02;
DeRoyal Basic Pack, REF 89-5155.02, Lot 12624777, exp
2010-01;
DeRoyal Abdominalplasty Tray, REF 89-5677.01,
Lot 12364573, exp 2009-10;
DeRoyal Extremity Pack, REF
89-5812.01, Lot 12624929, exp 2012-05;
DeRoyal General Orthopedic Tray, REF 89-2851.06, Lots: 12578336,
exp 2012-05;
DeRoyal Total Hip
Pack, REF 89-3876.03, Lot 12578598, exp 2012-05;
DeRoyal
LAMI Pack, REF 89-4114.03, Lot 12578660, exp 2008-12;
DeRoyal Podiatry Tray, REF 50-13341.04, Lot 12578811, exp 2008-12;
DeRoyal Total Knee Tray, REF 89-3288.04, Lot 12578993,
exp 2012-05;
DeRoyal Basic LAP Tray, REF 89-3297.06, Lot
12579005, exp 2012-01;
DeRoyal Radical Prost Tray Pgybk,
REF 89-4558.03, Lots: 12579806,
exp 2009-03 and 12537016,
exp 2009-04;
DeRoyal NW ASC Shoulder Arthro, REF
89-4569.07, Lot 12579814,
exp
2008-12;
DeRoyal TVT Pack, REF 89-5782.01, Lots: 12580727,
exp 2010-01
and 12538203, exp
2010-01;
DeRoyal Double Basin Set, REF 89-0191.05, Lot
12580807, exp 2008-11;
DeRoyal Vascular AV Fistula Pack,
REF 50-8118.08, Lot 12580874, exp 2012-05;
DeRoyal
Arthroscopy Pack, REF 50-12988.10, Lot 12556006, exp 2012-05;
DeRoyal Gyn Laparoscopy, REF 89-2646.10, Lot 12556196,
exp 2011-11;
DeRoyal Heart Tray, REF 89-3916.05 A, Lot
12571927, exp 2009-03;
DeRoyal Heart Tray, REF 89-3916.05
B, Lot 12571927, exp 2009-03;
DeRoyal Arthroscopy Tray,
REF 89-5714.01, Lot 12572401, exp 2010-02;
DeRoyal Lumbar
Disk, REF 89-3390.06, Lot 12535310, exp 2009-03;
DeRoyal
Cath Lab Accessory Tray, REF 89-4023.07, Lot 12535547, exp 2009-02;
DeRoyal Extremity Pack, REF 89-2565.08, Lot 12535598, exp
2012-05;
DeRoyal Custom hand Tray, REF 89-4593.03, Lot
12537067, exp 2009-01;
DeRoyal Basic Major Tray, REF
94-0283.11, Lot 12537201, exp 2012-05;
DeRoyal Cardiac
Cath Lab Tray, REF 89-5109.01, Lot 12537251, exp 2012-05;
DeRoyal Open Heart Drape Pack, REF 89-5202.01, Lot 12537358, exp
2012-05;
DeRoyal Total Hip A&B Pack Pgybk, REF
89-5285.01 A, Lot 12537500, exp 2009-01;
DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 B,
Lot 12537500, exp 2009-01;
DeRoyal
Clevens Facelift Pack, REF 89-5728.01, Lot 12538094, exp 2010-01;
DeRoyal C-Section Tray, REF 50-12505.08, Lot 12538596,
exp 2008-12;
b) 1) Lot: 12781158, exp 2008-10, 2) Lot 12830124, exp
2010-01,
3) Lot: 12585413, exp 2008-08, 4)
Lot 12388751, exp 2009-02,
5) Lot: 12680189, exp
2008-11, 6) Lot 12729915, exp 2008-11,
7) Lot:
12924403, exp 2010-05, 8)) Lot 12493236, exp 2011-09,
9) Lot: 12585296, exp 2009-03, 10) Lot 12570676,
exp 2008-1105,
11) Lot: 12617657, exp 2008-02, 12) Lot
11829924, exp 2008-10,
13) Lot: 12866047, exp 2008-10, 14) Lot
12585405, exp 2009-03,
15) Lot: 12671151, exp 2008-01, 16) Lot
12862695 exp 2009-04,
17) Lot: 12671101, exp
2009-02
RECALLING FIRM/MANUFACTURER DeRoyal Lafollette,
LaFollette, TN
REASON Packaging failure. Lack of
sterility assurance.
VOLUME OF PRODUCT IN COMMERCE 1,826
cases
DISTRIBUTION Nationwide
PRODUCT Spectrum
Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number
120-224S,
CODE Lot number 30838,
serial numbers BAE256 through BAE275, manufactured June, 2006. Expiration date
is five years from date of manufacture.
RECALLING
FIRM/MANUFACTURER Spectrum Designs, Inc., Carpinteria, CA,
REASON
The product is being recalled
because it was discovered that at least one unit in the lot contained a
mismatched pair (two rights and no left). Since the lot was produced with equal
numbers of pairs, it is assumed that one other unit was packaged with two lefts
and no right. This was discovered through a physician complaint.
VOLUME OF PRODUCT IN COMMERCE 15 pair
(left/right)
DISTRIBUTION Nationwide
PRODUCT Multi-Link
Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15,
CODE
Lot # 7052951
RECALLING
FIRM/MANUFACTURER Abbott Vascular-Cardiac Therapies dba Guidant
Corporation, Temecula, CA
REASON The affected single lot
did not meet an internal specification. One unit failed the test criteria for
stent dislodgment testing.
VOLUME OF PRODUCT IN
COMMERCE 43
units
DISTRIBUTION Nationwide
PRODUCT
a)
Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF
21-7100-24, Sterile,
b) Smiths
CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC 4694-24A, REF
21-7001-24, Sterile,
c) Smiths CADD
Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4695-24A, REF
21-7002-24, Sterile EO,
CODE
a) 083X16, 084X16, 116X16, 131X16,137X16,
140X16, 146X16, 151X16, 162X16, 185X16, 198X16, 224X16,
225X16;
b) 102X16, 117X16, 118X16, 130X16, 133X16, 135X16, 139X16, 147X16, 150X16, 158X16, 165X16, 178X16, 180X16, 181X16, 188X16,
191X16, 194X16, 202X16, 205X16,
226X16;
c) 081X16, 082X16, 085X16, 088X16, 089X16, 090X16,
091X16, 094X16, 095X16, 096X16, 097X16, 104X16, 105X16,
106X16, 107X16, 109X16, 110X16, 112X16, 113X16, 115X16,
119X16, 120X16, 121X16, 122X16, 123X16, 128X16, 129X16,
136X16, 138X16, 142X16, 144X16, 145X16, 149X16, 152X16, 154X16, 155X16, 157X16, 160X16, 161X16, 163X16, 164X16, 167X16, 168X16,
169X16, 170X16, 171X16, 172X16, 173X16, 176X16, 177X16,
179X16, 182X16, 183X16, 186X16, 187X16, 189X16, 190X16,
192X16, 195X16, 196X16, 199X16, 200X16, 203X16,
204X16,
206X16, 207X16, 209X16, 210X16, 211X16, 212X16, 213X16, 214X16, 216X16, 218X16, 220X16, 221X16, 222X16, 223X16, 228X16,
229X16
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths
Medical MD, Inc., Saint Paul, MN
Manufacturer: Smiths Healthcare Manufacturing
S.A. de C.V., Tijuana,
B.C., Mexico.
REASON Smith Medical has become aware that an
increase in pH may occur with some medications when instilled in the Affected
Cassettes. Also, a small number of catheter occlusions have been reported from
one customer when these cassettes have been used for delivering Flolan.
VOLUME OF PRODUCT IN COMMERCE 148,377 boxes (1780524
cassettes)
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator,
b) LX125V Swivel Collimator,
Model E600; Manual Radiographic
Collimator,
c) PCS125 Swivel Collimator, Model F100; Manual Radiographic
Collimator,
CODE
a) Serial numbers NA578-1092 to
NE785-0201, all swivel units manufactured between
11/14/1992 and 02/13/2001;
b) Serial numbers VA163-1192 to VB985-0798, all
swivel units manufactured between 11/14/1992 and
07/31/1998;
c) Serial numbers WA153-1092 to WA153-0697, all swivel units
manufactured between 10/01/1992 and
06/30/1997
RECALLING FIRM/MANUFACTURER Summit Industries,
Inc., Chicago, IL
REASON The D800 Swivel Collimator may come loose
from the tube stand and fall onto the x-ray table.
VOLUME OF PRODUCT
IN COMMERCE 3,034
units
DISTRIBUTION Nationwide and Internationally
WEEK ENDING SEPTEMBER 15
PRODUCT BD
Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green.
21 Gauge. Translucent, integrated protective shield that provides one-handed
activation immediately after use, 0.75 in needle length, 12 in tubing, Luer
adapter and holder, wings, sterile, Catalog # 368652,
CODE
Lot Numbers: 5236082; 5236093;
5236095
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Becton Dickinson & Company, Franklin Lakes, NJ
Manufacturer: BD Medical Systems Infusion Therapy, Nogales, Sonora,
Mexico.
REASON The BD
Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem
where the non-patient needle (in the holder) may become separated from the hub
and remain the stopper of an evacuated blood collection tube.
VOLUME
OF PRODUCT IN COMMERCE 147,200
units
DISTRIBUTION Nationwide and
Canada.
PRODUCT OneTouch
Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring
systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch
UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of
100 and 50. (Part numbers: 020-245-07 (100 pack), 020-244-07 (50 pack),
020-963-01(50 pack mail order)),
CODE Expiration dates 08/2007 through
11/2008
RECALLING FIRM/MANUFACTURER LifeScan, Inc.,
Milpitas, CA
REASON Damaged Vials/Inaccurate test results: a
manufacturing equipment problem on one of the packaging lines had the potential
to puncture vials, causing a single hole in the side of the vial below the rim.
This result of this defect may produce inaccurately high or low blood glucose
test results or error message readings.
VOLUME OF PRODUCT IN
COMMERCE 33 million vials
DISTRIBUTION Worldwide; USA, Europe, Middle East,
Africa, Latin America and
Canada.
PRODUCT Intellivue
Central Station Software for the: Intellivue Information Center, Philips
Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169,
CODE
Software versions: J.00.23 and
J.00.24
RECALLING FIRM/MANUFACTURER Philips Medical
Systems, Andover, MA
REASON Incorrect Patient Assignment: The
information center will in most cases be associated with the “incorrect”
patient.
VOLUME OF PRODUCT IN COMMERCE 26
units
DISTRIBUTION NJ, NY, OK, MI, UT, Australia,
Finland, France, Netherlands, and
UK
PRODUCT Kion
Anesthesia Workstation, Article number: 6454800, CODE Serial #: 1719, 2034, 3078, 3416, 3417,
3418, 3419, 3420, 3027
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater,
NJ
Manufacturer: Maquet Critical Care AB, Solna,
Sweden.
REASON Overcharging of batteries and the release
of acid fumes.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION Nationwide
PRODUCT Biogel
Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8),
CODE
Lot #: 07B026, Size
8
RECALLING FIRM/MANUFACTURER
Recalling Firm: Molnlycke
Health Care, Inc., Norcross, GA
Manufacturer: Regent Hospital Products, Sdn
Bhd, Kulim, Kedah Darulaman, Malaysia.
REASON Sterility compromised (package
integrity): The primary packaging for a portion of the lot may contain gloves
that were not sealed properly.
VOLUME OF PRODUCT IN
COMMERCE 6,000
pair
DISTRIBUTION Nationwide
PRODUCT
a)
BioHorizons 0.035 Hex Driver, REF 300-377, non-sterile, Rx only, REF 300-377,
b) BioHorizons
0.050 Hex Driver, Regular, REF 300-350, non-sterile, Rx only,
c) BioHorizons 0.050 Hex
Driver, Long, REF 300-351, non-sterile, Rx only,
d) BioHorizons 0.050 Hex Driver, Regular, REF 134-350,
non-sterile, Rx only. The product is part of a Prosthetic
Instrumentation system Kit 51-K,
CODE
a) Lot No 09040003
b) Lot No.
06060009
c) Lot Number: 08060239;
d) Lot Number:
11060189
RECALLING FIRM/MANUFACTURER BioHorizons Implant
Systems, Inc., Birmingham, AL
REASON Premature wear; The
material from which the hex driver was made was improperly hardened during
manufacturing and could lead to premature wear.
VOLUME OF PRODUCT IN
COMMERCE 1,294 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a)
Avazzia Tennant Biomodulator®; Model: BEST AV-1; P/N #TB04303-103,
b) Avazzia BEST-RSI; Model: BEST
AV-1; P/N #RS04303-103,
c)
Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1;
P/N #MB04182-103,
d) Avazzia Med-Sport Massager; Model:
BEST AV-1; P/N #MS04182-103,
CODE
a) Lot # TB07120-AC024;
b)
Lot # RS07120-AC024;
c) Lot # MB07120-AC024;
d) Lot #
MS07120-AC024
RECALLING FIRM/MANUFACTURER Avazzia, Inc.,
Dallas, TX, REASON Plastic Cases may crack due to
manufacturing by the supplier not meeting specifications.
VOLUME OF
PRODUCT IN COMMERCE 278
units
DISTRIBUTION TX, PA, LA, WY, and CA
B. Braun Medical Inc. Issues Recall of Normal Saline Flush Syringes with Lot Numbers Ending in "SFR"
B. Braun Medical Inc., Bethlehem, PA, announced a nationwide recall of Normal Saline Flush syringes with lot numbers ending in "SFR" due to an increase in customer complaints for particulate matter in the saline.
Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to usage of this product. Customers that have the affected product in their possession may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.
This recall affects normal saline 3mL in 12mL syringes, designated by product code 513584, and normal saline 10mL in 12mL syringes, designated by product code 513587. Between June 11 and July 18 of this year, B. Braun Medical Inc. distributed approximately 33,000 units of product code 513584 and 1.2 million units of product code 513587 of lot numbers ending in "SFR" to hospitals and distributors. The product code, identified as REF, and lot number, identified as LOT, can be found on the syringe label just below the product description.
WEEK ENDING SEPTEMBER 22
PRODUCT
a)
Clinical Chemistry Lipase, in vitro diagnostic test reagent.
List Numbers:
7D80-20 and 7D80-30,
b) MULTIGENT Acetaminophen, in
vitro diagnostic test reagent.
List Number 2K99-20,
CODE
a) Control Numbers: 37033HW00,
33032HW00, 30053HW00, 47048HW00, 45067HW00, 43002HW00, 42016HW00 &
42010HW00;
b) Control Numbers: 30455UQ11 & 31046UQ02
RECALLING
FIRM/MANUFACTURER Abbott Laboratories, Inc., South Pasadena, CA
REASON
Lipase results are falsely elevated when
a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from
the same sample cup or tube on the ARCHITECT c8000.
VOLUME OF PRODUCT
IN COMMERCE 7,602
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT The
product is an isolation transformer, an accessory to Computed Tomography
Scanner. It consists of electronic circuitry enclosed in a metal case. According
to Philips Medical Systems, the metal case is manufactured from
self-extinguishing materials. The unit is labeled in part, "Power Conditioner
*** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: ***
INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL
POWER SUPPLY UL ***
CODE
Part
Number: 4450028-01; Serial Numbers: 73343, 74482, 74481, 74480, 74477, 74478,
74479, 74639, 74637, 74640, 74638, 74641, 74758, 79281, 79279, 79282, 79278,
79280, 79348, 79347, 79345, 79346, 79512, 79513, 79514, 79511, 79515, 79582,
79699, 79698, 79696, 79697, 79700, 79778, 79774, 79776, 79773, 79775, 79772,
79777, 79898, 79899, 79893, 79894, 79892, 79897, 79896, 79891, 79895, 79976,
79980, 79978, 79975, 79977, 79979, 79974, 80060, 80132, 80125, 80127, 80123,
80124, 80131, 80161, 80128, 80130, 80129, 80126, 80571, 80570, 80574, 80579,
80577, 80572, 80573, 80578, 80575, 80576, 80729, 80730, 80894, 80895, 80896,
80934, 80932, 80897, 80931, 80933, 80935, 80848, 81007, 81004, 81008, 81005,
81010, 81009, 81006, 81090, 81091, 81095, 81093, 81089, 81092, 91094, 746390.
Part Number 4450028-02; Serial Numbers: 80583, 81116, 81121, 81117, 81115,
81119, 81128, 81118, 81120, 81126, 81122, 81123, 81125, 81127, 81124, 81129,
81168, 81165, 81169, 81167, 81166, 81170, 81179, 81177, 81171, 81175, 81176,
81351, 81354, 81347, 81348, 81349, 81353, 81350, 81346, 81355, 81352, 81173,
81174, 81172, 81178, 81446, 81454, 81458, 81459, 81455, 81448, 81445, 81449,
81447, 81456, 81457, 81453, 81451, 81452, 81450, 81826, 81830, 81827, 81829,
81828, 81851, 81853, 81852, 81854, 81855, 82053, 82054, 82051, 82052, 82050,
82114, 82112, 82113, 82116, 82119, 82115, 82117, 82120, 82121, 82118, 82154,
82156, 82155, 82157, 82153, 82267, 82266, 82273, 82268, 82265, 82269, 82274,
82271, 82272, 82270, 82387, 82386, 82385, 82383, 82384, 82472, 82473, 82476,
82474, 82475, 82519, 82521, 82518, 82517, 82520, 82604, 82600, 82598, 82603,
82602, 82599, 82607, 82605, 82606, 82601, 82705, 82708, 82707, 82704, 82706,
82798, 82797, 82801, 82799, 82800, 82928, 82927, 82926, 82924, 82925, 83010,
83011, 83012, 83014, 83013, 83109, 83108, 83107, 83106, 83115, 83112, 83110,
83111, 83113, 83114, 83156, 83157, 83158, 83159, 83160, 83155, 83161, 83164,
83162, 83276, 83269, 83272, 83273, 83163, 83271, 83274, 83275, 83277, 83270,
83278, 83381, 83378, 83380, 83375, 83377, 83373, 83374, 83379, 83382, 83376,
73546, 83543, 83548, 83543, 83547, 83544, 83549, 83550, 83551, 83552, 83675,
83676, 83673, 83678, 83681, 83679, 83677, 83674, 83672, 83680, 83748, 83746,
83745, 83744, 83747, 83882, 83878, 83875, 83876, 83877, 83880, 83883, 83884,
83879, 83881, 83881, 83884, 83879, 83880, 83883, 84010, 84014, 84009, 84013,
84008, 84011, 84012, 84016, 84007, 84015, 84065, 84064, 84066, 84072, 84071,
84070, 84069, 84067, 84068, 84073, 84209, 84211, 84212, 84213, 84207, 84210,
84208, 84215, 84216, 84236, 84239, 84233, 84237, 84231, 84235, 84238, 84240,
84232, 84234, 83672, 84519, 84517, 84514, 84516, 84515, 84513, 83877, 83878,
84518, 84520, 84523, 84525, 84526, 84521, 84524, 84522, 84527, 84597, 84598,
84595, 84599, 84596, 84600, 84849, 84854, 84853, 84852, 84850, 84848, 84855,
84851, 84857, 84856, 85014, 85007, 85012, 85006, 85010, 85011, 85009, 85015,
85005, 85016, 85008, 85013, 85017, 85004, 85003, 83678, 85148, 85151, 85149,
85154, 85156, 85152, 85150, 85155, 85157, 85253, 85256, 85258, 85259, 85257,
85254, 85252, 85255, 85153, 85262, 85261, 85260, 85263, 85265, 85264, 85266,
85281, 85282, 85283, 85284, 85286, 85289, 85290, 85287, 85285, 85288, 85320,
85318, 85314, 85313, 85317, 85321, 85316, 85322, 85323, 85325, 85327, 85319,
85333, 85324, 85326, 85332, 85347, 85330, 85315, 85349, 85348, 85336, 85335,
85334, 85337, 85351, 85340, 85353, 85350, 85355, 85339, 85356, 85374, 85352,
85354, 85372, 85371, 85373, 85379, 85378, 85377, 85376, 85375, 85380, 85790,
85791, 85792, 85786, 85785, 85793, 85788, 85784, 85787,
85789
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips
Medical Systems (Cleveland) Inc., Cleveland, OH
Manufacturer: Teal Electronics Corp., San Diego, CA.
REASON
The TEAL Power
Conditioning units may fail and result in the unit emitting fire and/or smoke.
Note: the TEAL Power Conditioning Unit has the potential to fail when the
scanner that is attached to the TEAL is powered and in use as well as when not
in use.
VOLUME OF PRODUCT IN COMMERCE 491
units
DISTRIBUTION Nationwide and Internationally
WEEK ENDING SEPTEMBER 29
PRODUCT Welch
Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery
powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo
Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216
(Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E),
CODE
Serial number range -
205787 - 207509 (non-contiguous) 205787, 205788, 205789, 205790, 205791, 205793,
205794, 205795, 205796, 205797, 205798, 205799, 205800, 205801, 205802, 205803,
205804, 205805, 205807, 205808, 205809, 205810, 205811, 205812, 205813, 205814,
205815, 205816, 205817, 205818, 205819, 205820, 205821, 205822, 205823, 205824,
205825, 205826, 205827, 205828, 205829, 205830, 205831, 205832, 205833, 205834,
205835, 205836, 205837, 205838, 205839, 205840, 205841, 205842, 205843, 205844,
205845, 205846, 205847, 205848, 205849, 205850, 205851, 205852, 205853, 205854,
205855, 205856, 205857, 205858, 205860, 205861, 205862, 205863, 205864, 205865,
205866, 205867, 205868, 205869, 205870, 205871, 205872, 205873, 205874, 205875,
205876, 205877, 205878, 205879, 205880, 205881, 205882, 205883, 205884, 205885,
205886, 205887, 205888, 205889, 205890, 205891, 205892, 205893, 205894, 205897,
205898, 205899, 205900, 205901, 205902, 205903, 205904, 205905, 205906, 205908,
205909, 205910, 205911, 205912, 205913, 205914, 205915, 205916, 205917, 205918,
205919, 205920, 205921, 205922, 205923, 205924, 205925, 205926, 205927, 205928,
205929, 205930, 205931, 205932, 205933, 205934, 205935, 205936, 205937, 205938,
205939, 205940, 205941, 205942, 205943, 205944, 205945, 205946, 205947, 205948,
205949, 205950, 205951, 205952, 205953, 205954, 205956, 205957, 205958, 205959,
205960, 205961, 205962, 205963, 205964, 205965, 205966, 205967, 205968, 205969,
205970, 205971, 205972, 205973, 205974, 205975, 205976, 205977, 205978, 205979,
205980, 205981, 205982, 205983, 205984, 205985, 205986, 205987, 205988, 205989,
205990, 205991, 205992, 205994, 205995, 205996, 205997, 205998, 205999, 206000,
206001, 206002, 206003, 206004, 206005, 206006, 206007, 206008, 206009, 206010,
206011, 206012, 206013, 206014, 206015, 206016, 206017, 206018, 206019, 206020,
206021, 206022, 206023, 206024, 206025, 206026, 206027, 206028, 206029, 206030,
206032, 206033, 206034, 206035, 206036, 206037, 206038, 206039, 206040, 206041,
206042, 206043, 206044, 206045, 206046, 206047, 206048, 206049, 206050, 206051,
206052, 206053, 206054, 206055, 206056, 206057, 206059, 206060, 206061, 206062,
206063, 206064, 206065, 206066, 206067, 206068, 206069, 206070, 206071, 206072,
206074, 206075, 206076, 206077, 206078, 206079, 206080, 206081, 206082, 206083,
206084, 206085, 206086, 206087, 206088, 206089, 206090, 206091, 206092, 206093,
206094, 206095, 206096, 206097, 206098, 206099, 206100, 206101, 206102, 206103,
206104, 206105, 206106, 206107, 206108, 206109, 206110, 206111, 206112, 206113,
206114, 206115, 206116, 206118, 206119, 206120, 206121, 206122, 206123, 206124,
206125, 206126, 206127, 206128, 206129, 206130, 206131, 206132, 206133, 206134,
206135, 206136, 206137, 206138, 206139, 206140, 206141, 206142, 206143, 206144,
206145, 206147, 206148, 206149, 206150, 206151, 206152, 206153, 206154, 206155,
206156, 206157, 206158, 206159, 206160, 206161, 206162, 206163, 206164, 206165,
206167, 206168, 206169, 206170, 206171, 206172, 206173, 206174, 206175, 206176,
206177, 206178, 206179, 206180, 206181, 206182, 206183, 206184, 206185, 206186,
206187, 206188, 206189, 206190, 206191, 206192, 206193, 206194, 206195, 206196,
206197, 206198, 206199, 206200, 206201, 206202, 206203, 206204, 206205, 206206,
206207, 206208, 206209, 206210, 206211, 206212, 206213, 206214, 206215, 206216,
206217, 206218, 206219, 206220, 206221, 206222, 206223, 206224, 206225, 206226,
206227, 206228, 206229, 206230, 206231, 206232, 206233, 206234, 206235, 206236,
206237, 206238, 206239, 206240, 206241, 206242, 206243, 206244, 206245, 206246,
206247, 206248, 206249, 206250, 206251, 206252, 206253, 206254, 206255, 206256,
206257, 206258, 206259, 206260, 206261, 206263, 206264, 206265, 206266, 206267,
206268, 206269, 206270, 206271, 206272, 206273, 206274, 206275, 206276, 206277,
206278, 206279, 206280, 206281, 206282, 206283, 206284, 206285, 206286, 206287,
206288, 206289, 206290, 206291, 206292, 206293, 206294, 206296, 206297, 206298,
206299, 206300, 206301, 206302, 206303, 206304, 206305, 206306, 206307, 206308,
206309, 206310, 206311, 206312, 206313, 206314, 206315, 206316, 206317, 206318,
206319, 206320, 206321, 206322, 206323, 206324, 206325, 206326, 206327, 206328,
206329, 206331, 206332, 206333, 206334, 206335, 206336, 206337, 206338, 206339,
206340, 206341, 206342, 206343, 206344, 206345, 206346, 206347, 206348, 206349,
206350, 206351, 206352, 206353, 206354, 206355, 206356, 206357, 206358, 206359,
206360, 206361, 206362, 206363, 206364, 206365, 206366, 206367, 206368, 206369,
206370, 206371, 206372, 206373, 206375, 206376, 206377, 206378, 206379, 206380,
206381, 206382, 206383, 206384, 206385, 206386, 206387, 206388, 206389, 206390,
206391, 206392, 206394, 206395, 206396, 206397, 206398, 206399, 206400, 206401,
206402, 206403, 206404, 206405, 206406, 206407, 206410, 206411, 206412, 206413,
206414, 206415, 206416, 206417, 206418, 206419, 206420, 206421, 206422, 206423,
206424, 206425, 206426, 206427, 206428, 206429, 206430, 206431, 206432, 206433,
206434, 206435, 206436, 206437, 206438, 206439, 206440, 206441, 206442, 206443,
206444, 206445, 206446, 206447, 206448, 206449, 206450, 206451, 206452, 206453,
206454, 206455, 206456, 206457, 206458, 206459, 206460, 206461, 206462, 206463,
206464, 206465, 206466, 206467, 206468, 206469, 206470, 206471, 206472, 206473,
206474, 206475, 206476, 206477, 206478, 206479, 206480, 206481, 206482, 206483,
206484, 206485, 206486, 206488, 206489, 206490, 206491, 206492, 206493, 206494,
206496, 206497, 206498, 206499, 206500, 206501, 206502, 206503, 206504, 206505,
206506, 206507, 206508, 206509, 206510, 206511, 206512, 206513, 206514, 206515,
206516, 206517, 206518, 206519, 206520, 206521, 206522, 206523, 206524, 206525,
206526, 206527, 206528, 206529, 206530, 206531, 206532, 206533, 206534, 206535,
206536, 206537, 206538, 206539, 206540, 206541, 206542, 206543, 206544, 206545,
206546, 206547, 206549, 206550, 206551, 206552, 206553, 206554, 206555, 206556,
206557, 206558, 206560, 206561, 206562, 206563, 206564, 206565, 206566, 206567,
206569, 206571, 206572, 206575, 206576, 206577, 206578, 206579, 206580, 206581,
206582, 206583, 206584, 206585, 206586, 206587, 206588, 206589, 206590, 206591,
206592, 206593, 206594, 206595, 206596, 206597, 206598, 206599, 206600, 206602,
206603, 206604, 206605, 206606, 206607, 206608, 206609, 206610, 206611, 206612,
206613, 206614, 206617, 206618, 206619, 206620, 206621, 206622, 206623, 206624,
206625, 206626, 206627, 206628, 206629, 206630, 206631, 206632, 206633, 206634,
206635, 206636, 206637, 206638, 206639, 206641, 206642, 206643, 206644, 206645,
206646, 206647, 206648, 206649, 206650, 206651, 206652, 206653, 206654, 206655,
206656, 206657, 206658, 206659, 206660, 206661, 206662, 206663, 206664, 206665,
206666, 206667, 206668, 206669, 206670, 206671, 206672, 206673, 206674, 206675,
206676, 206677, 206678, 206679, 206680, 206681, 206682, 206683, 206684, 206685,
206686, 206687, 206688, 206689, 206690, 206691, 206692, 206693, 206694, 206695,
206696, 206697, 206698, 206699, 206700, 206701, 206703, 206704, 206705, 206706,
206707, 206708, 206709, 206710, 206711, 206712, 206713, 206715, 206716, 206717,
206718, 206719, 206720, 206721, 206722, 206724, 206725, 206726, 206727, 206728,
206729, 206730, 206731, 206732, 206733, 206734, 206735, 206736, 206737, 206738,
206739, 206740, 206741, 206742, 206743, 206744, 206745, 206746, 206747, 206748,
206749, 206750, 206751, 206752, 206753, 206754, 206755, 206756, 206757, 206758,
206759, 206760, 206761, 206762, 206763, 206764, 206765, 206766, 206768, 206769,
206770, 206771, 206772, 206773, 206775, 206776, 206777, 206778, 206779, 206780,
206781, 206782, 206783, 206784, 206785, 206786, 206787, 206788, 206789, 206790,
206791, 206792, 206793, 206794, 206795, 206796, 206797, 206798, 206799, 206800,
206801, 206802, 206803, 206804, 206805, 206806, 206807, 206808, 206809, 206810,
206811, 206812, 206813, 206814, 206815, 206816, 206817, 206818, 206819, 206820,
206821, 206822, 206823, 206824, 206825, 206826, 206827, 206828, 206829, 206830,
206831, 206832, 206833, 206834, 206835, 206836, 206837, 206838, 206839, 206840,
206841, 206842, 206843, 206844, 206845, 206846, 206847, 206848, 206849, 206850,
206851, 206852, 206853, 206854, 206855, 206856, 206858, 206860, 206861, 206862,
206863, 206864, 206867, 206868, 206869, 206870, 206871, 206872, 206873, 206874,
206875, 206876, 206877, 206878, 206879, 206880, 206881, 206882, 206883, 206884,
206885, 206886, 206887, 206888, 206889, 206890, 206891, 206892, 206893, 206894,
206895, 206896, 206897, 206898, 206899, 206900, 206901, 206902, 206903, 206904,
206905, 206906, 206907, 206908, 206909, 206910, 206911, 206912, 206913, 206914,
206915, 206916, 206917, 206918, 206919, 206920, 206921, 206922, 206923, 206924,
206925, 206926, 206927, 206928, 206929, 206930, 206931, 206932, 206933, 206934,
206935, 206936, 206937, 206938, 206939, 206940, 206941, 206942, 206943, 206944,
206945, 206946, 206947, 206948, 206949, 206950, 206951, 206952, 206953, 206954,
206955, 206956, 206957, 206958, 206959, 206960, 206961, 206962, 206963, 206964,
206965, 206966, 206967, 206969, 206970, 206971, 206972, 206973, 206974, 206975,
206976, 206977, 206978, 206979, 206980, 206981, 206982, 206983, 206984, 206985,
206986, 206987, 206988, 206989, 206990, 206991, 206992, 206993, 206994, 206995,
206996, 206997, 206998, 206999, 207000, 207001, 207002, 207003, 207004, 207005,
207006, 207007, 207008, 207009, 207010, 207011, 207012, 207013, 207015, 207016,
207017, 207018, 207020, 207022, 207023, 207024, 207026, 207027, 207028, 207029,
207030, 207031, 207032, 207033, 207034, 207035, 207036, 207037, 207039, 207040,
207041, 207042, 207043, 207044, 207045, 207046, 207047, 207048, 207049, 207050,
207051, 207052, 207053, 207054, 207055, 207056, 207057, 207058, 207059, 207060,
207061, 207062, 207063, 207064, 207065, 207066, 207067, 207068, 207069, 207070,
207071, 207072, 207073, 207074, 207075, 207076, 207077, 207078, 207079, 207080,
207081, 207082, 207083, 207084, 207085, 207086, 207087, 207088, 207089, 207090,
207091, 207092, 207093, 207094, 207095, 207096, 207097, 207098, 207099, 207100,
207101, 207102, 207103, 207104, 207105, 207106, 207107, 207108, 207110, 207111,
207112, 207113, 207114, 207115, 207116, 207117, 207118, 207119, 207120, 207121,
207122, 207123, 207124, 207125, 207126, 207127, 207128, 207129, 207130, 207131,
207132, 207133, 207134, 207135, 207137, 207138, 207139, 207140, 207141, 207142,
207143, 207144, 207145, 207146, 207147, 207148, 207149, 207150, 207151, 207152,
207153, 207154, 207155, 207156, 207157, 207158, 207159, 207160, 207161, 207162,
207164, 207165, 207166, 207169, 207171, 207172, 207173, 207174, 207175, 207176,
207177, 207178, 207179, 207180, 207181, 207182, 207183, 207184, 207185, 207186,
207187, 207188, 207189, 207190, 207191, 207192, 207194, 207195, 207196, 207197,
207198, 207199, 207200, 207201, 207202, 207203, 207204, 207205, 207206, 207207,
207208, 207210, 207211, 207212, 207213, 207214, 207215, 207216, 207217, 207218,
207219, 207220, 207221, 207222, 207223, 207224, 207225, 207226, 207227, 207228,
207229, 207230, 207231, 207232, 207233, 207234, 207235, 207237, 207238, 207239,
207240, 207241, 207242, 207243, 207244, 207245, 207246, 207247, 207248, 207249,
207250, 207251, 207252, 207253, 207254, 207255, 207256, 207257, 207258, 207259,
207260, 207261, 207262, 207263, 207264, 207265, 207266, 207267, 207268, 207270,
207271, 207272, 207273, 207274, 207275, 207276, 207277, 207278, 207279, 207280,
207282, 207283, 207284, 207285, 207286, 207287, 207288, 207289, 207290, 207291,
207292, 207293, 207294, 207295, 207296, 207297, 207298, 207299, 207300, 207301,
207302, 207303, 207304, 207305, 207306, 207307, 207308, 207309, 207310, 207311,
207312, 207313, 207314, 207315, 207316, 207317, 207318, 207319, 207320, 207321,
207322, 207323, 207324, 207325, 207326, 207327, 207328, 207329, 207330, 207331,
207332, 207333, 207334, 207335, 207336, 207337, 207338, 207339, 207340, 207341,
207342, 207343, 207344, 207345, 207346, 207347, 207348, 207349, 207350, 207351,
207352, 207353, 207354, 207355, 207356, 207357, 207358, 207359, 207360, 207361,
207362, 207363, 207364, 207365, 207366, 207367, 207368, 207369, 207370, 207371,
207372, 207373, 207374, 207375, 207376, 207377, 207378, 207379, 207380, 207381,
207382, 207383, 207384, 207387, 207389, 207390, 207391, 207392, 207393, 207394,
207395, 207396, 207397, 207398, 207399, 207400, 207401, 207402, 207403, 207404,
207405, 207406, 207407, 207408, 207409, 207410, 207411, 207412, 207413, 207414,
207415, 207416, 207417, 207418, 207419, 207420, 207421, 207422, 207423, 207424,
207425, 207426, 207427, 207428, 207429, 207430, 207431, 207432, 207433, 207434,
207435, 207436, 207437, 207438, 207439, 207440, 207442, 207443, 207444, 207445,
207445, 207446, 207447, 207448, 207449, 207450, 207451, 207452, 207453, 207454,
207455, 207456, 207457, 207458, 207459, 207460, 207461, 207462, 207463, 207464,
207465, 207467, 207468, 207469, 207470, 207472, 207473, 207474, 207475, 207476,
207477, 207478, 207479, 207481, 207484, 207485, 207486, 207487, 207492,
207495
RECALLING FIRM/MANUFACTURER
Recalling Firm: Welch
Allyn Protocol, Inc., Beaverton, OR,
Manufacturer: MRL, Inc., A Welch Allyn
Company, Buffalo Grove, IL. REASON Failure to deliver shock: The Welch
Allyn AED20 Defibrillators may display a "Defib Comm" error message on the
device display during use which may result in failure of the device to analyze
the patient's ECG and deliver the appropriate therapy.
VOLUME OF
PRODUCT IN COMMERCE 1,722
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT Baxter
Colleague CX Single Channel Volumetric Infusion Pumps; product code 2M8161,
CODE
Serial numbers: 14051565CC,
15034273CC, 15034492CC, 15040255CC, 15041116CC, 15041169CC, 15041170CC,
15041172CC, 15041181CC, 15041194CC, 15041199CC, 15041206CC, 15041212CC,
15041218CC, 15041241CC, 15041288CC, 15041290CC, 15041317CC, 15050020CC,
15050034CC, 15050045CC, 15050061CC, 15050080CC, 15050117CC, 15050129CC,
15060087CC, 15060217CC, 15060253CC, 15060479CC, 15060489CC, 15060549CC,
15060557CC, 15060600CC, 15060738CC, 15060790CC, 15060827CC, 15060939CC,
15060940CC, 15060968CC, 15063211CC, 15075371CC, 15075103CC
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round
Lake, IL,
Manufacturer: Baxter Healthcare
Corp., Singapore, Singapore.
REASON Some of the pumps were upgraded by one service
technician who failed to replace prisms and batteries as required in the
upgrade.
VOLUME OF PRODUCT IN COMMERCE 42
pumps
DISTRIBUTION FL and CA
PRODUCT Stryker
Medical – Wheeled Electric Stretcher, Model 1550, CODE
Serial numbers 0508083666, 0509069531,
0509069532, 0509069533, 0509069534, 0509069535, 0509069542, 0509069564,
0509069565, 0509069566, 0509069567, 0509069568, 0509069569, 0509069588,
0509069589, 0509069590, 0509069591, 0509069662, 0509069663, 0509069664,
0509069665, 0509069693, 0509069694, 0509069695, 0509069696, 0509069697,
0509069698, 0509069699, 0509069700, 0509069701, 0509069770, 0509069771,
0509069772, 0509069773, 0509069774, 0509069775, 0509069776, 0509069777,
0509069778, 0509069795, 0509069796, 0509069806, 0509069816, 0509069817,
0509069818, 0509069819, 0509069832, 0509069835, 0509069836, 0509069837,
0509069838, 0509069839, 0509069840, 0509069841, 0509069848, 0509069849,
0509069873, 0509069874, 0509069875, 0509069876, 0509069877, 0510071024,
0510071025, 0510071026, 0510071032, 0510071033, 0510071034, 0510071035,
0510071036, 0510071037, 0510071038, 0510071039, 0510071040, 0510071041,
0510071042, 0510071043, 0510071154, 0510071155, 0510071156, 0510071157,
0510071158, 0510071159, 0510071160, 0510071205, 0510071206, 0510071207,
0510071208, 0510071209, 0510071210, 0510071231, 0510071232, 0510071233,
0510071234, 0510071235, 0510071263, 0510071264, 0510071265, 0510071266,
0510071267, 0510071308, 0510071309, 0510071310, 0510071311, 0510071312,
0510071327, 0510071328, 0510071329, 0510071349, 0510071350, 0510071351,
0510071352, 0510071353, 0510071354, 0510071355, 0510071356, 0511071505,
0511071506, 0511071507, 0511071508, 0511071509, 0511071510, 0511071511,
0511071512, 0511071513, 0511071514, 0511071515, 0511071516, 0511071572,
0511071573, 0511071574, 0511071575, 0511071576, 0511071577, 0511071578,
0511071579, 0511071583, 0511071584, 0511071585, 0511071593, 0511071594,
0511071595, 0511071596, 0511071597, 0511071598, 0511071599, 0511071600,
0511071601, 0511071602, 0511071603, 0511071604, 0511071605, 0511071653,
0511071654, 0511071655, 0511071656, 0511071687, 0511071688, 0511071689,
0511071690, 0511071691, 0511071692, 0511071693, 0511071694, 0511071695,
0511071696, 0511071697, 0511071698, 0511071699, 0511071725, 0511071726,
0512070508, 0512070509, 0512070510, 0512070511, 0512070517, 0512070518,
0512070519, 0512070520, 0512070521, 0512070522, 0512070523, 0512070524,
0512070535, 0512070536, 0512070537, 0512070538, 0512070539, 0512070540,
0512070541, 0512070542, 0512070544, 0512070597, 0512070598, 0512070599,
0512070600, 0512070607, 0512070608, 0512070609, 0512070610, 0512070611,
0512070612, 0512070613, 0512070614, 0512070648, 0512070649, 0512070650,
0512070651, 0512070656, 0512070657, 0512070658, 0512070659, 0512070660,
0512070661, 0512070701, 0512070702, 0512070703, 0512073509, 0512073510,
0512073511, 0512073518, 0512073519, 0512073529, 0512073530, 0512073531,
0512073532, 0512073533, 0512073587, 0512073588, 0512073589, 0512073590,
0512073591, 0512073592, 0512073593, 0512073594, 0512073609, 0512073610,
0512073611, 0512073612, 0512073613, 0512073614, 0512073634, 0512073635,
0512073636, 0601084021, 0601084022, 0601084023, 0601084024, 0601084025,
0601084026, 0601084027, 0601084028, 0601084029, 0601084030, 0601084080,
0601084081, 0601084082, 0601084104, 0601084107, 0601084108, 0601084109,
0601084110, 0601084111, 0601084135, 0601084136, 0601084141, 0601084142,
0601084143, 0601084144, 0601084145, 0601084146, 0601084147, 0601084199,
0601084200, 0601084201, 0601084202, 0601084203, 0601084204, 0601084214,
0601084215, 0601084227, 0601084228, 0601084229, 0601084230, 0601084231,
0601084232, 0601084233, 0601084234, 0601084241, 0601084242, 0601084243,
0601084244, 0601084245, 0601084252, 0601084253, 0601084254, 0601084255,
0601084261, 0601084262, 0601084263, 0601084264, 0601084267, 0601084268,
0601084269, 0601084270, 0601084271, 0601084272, 0601084273, 0601084274,
0601084275, 0601084276, 0601084277, 0601084278, 0601084279, 0601084280,
0601084325, 0601084326, 0601084327, 0601084328, 0601084329, 0601084330,
0601084359, 0601084360, 0601084361, 0601084362, 0601084363, 0601084364,
0601084382, 0601084383, 0601084384, 0601084385, 0601084386, 0602079501,
0602079502, 0602079503, 0602079504, 0602079505, 0602079506, 0602079524,
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0602079558, 0602079559, 0602079560, 0602079561, 0602079562, 0602079563,
0602079591, 0602079592, 0602079593, 0602079594, 0602079595, 0602079596,
0602079597, 0602079598, 0602079599, 0602079648, 0602079649, 0602079650,
0602079651, 0602079661, 0602079662, 0602079663, 0602079664, 0602079665,
0602079666, 0602079667, 0602079668, 0602079685, 0602079686, 0602079687,
0602079688, 0602079695, 0602079696, 0602079697, 0602079698, 0602079699,
0602079716, 0602079718, 0602079719, 0602079720, 0602079721, 0602079722,
0602079723, 0602079724, 0602079725, 0602079726, 0602079727, 0602079728,
0602079729, 0602079730, 0602079731, 0602079732, 0602079733, 0602079734,
0602079735, 0602079802, 0602079803, 0602079804, 0602079805, 0602079806,
0602079807, 0602079808, 0602079809, 0602079810, 0602079835, 0602079836,
0602079844, 0602079845, 0602079846, 0602079847, 0602079848, 0602079849,
0602079883, 0602079886, 0602079890, 0602079891, 0602079892, 0602079893,
0603084508, 0603084509, 0603084510, 0603084511, 0603084515, 0603084537,
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0603084634, 0603084635, 0603084636, 0603084637, 0603084638, 0603084644,
0603084645, 0603084647, 0603084648, 0603084649, 0603084689, 0603084742,
0603084743, 0603084744, 0603084745, 0603084746, 0603084747, 0603084773,
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0604079854, 0604079859, 0604079860, 0604079861, 0604079862, 0604079863,
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0605087662, 0605087663, 0605087721, 0605087722, 0605087723, 0605087727,
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0605087790, 0605087791, 0605087792, 0605087793, 0605087810, 0605087811,
0605087812, 0605087813, 0605087814, 0605087815, 0605087867, 0605087868,
0605087869, 0605087870, 0605087872, 0605087873, 0605087876, 0605087877,
0605087878, 0605087879, 0605087880, 0605087881, 0605087928, 0605087929,
0605087930, 0605087931, 0605087932, 0605087933, 0605087938, 0605087939,
0605087940, 0605087941, 0605087942, 0606079001, 0606079003, 0606079004,
0606079047, 0606079048, 0606079049, 0606079050, 0606079051, 0606079052,
0606079053, 0606079054, 0606079055, 0606079056, 0606079129, 0606079130,
0606079136, 0606079137, 0606079138, 0606079289, 0606079290, 0606079307,
0606079308, 0606079309, 0606079310, 0606079311, 0606079312, 0606079313,
0606079314, 0606079315, 0606079316, 0606079337, 0606079359, 0606079360,
0606079361, 0607080526, 0607080527, 0607080528, 0607080660, 0607080664,
0607080665, 0607080666, 0607080667, 0607080668, 0607080669, 0607080670,
0607080671, 0607080717, 0607080718, 0607080719, 0607080720, 0607080721,
0607080722, 0607080723, 0607080724, 0607080725, 0607080726, 0607080727,
0607080728, 0607080729, 0607080786, 0607080806, 0607080811, 0607080812,
0607080813, 0607080814, 0607080840, 0608080501, 0608080502, 0608080503,
0608080538, 0608080539, 0608080540, 0608080541, 0608080542, 0608080543,
0608080544, 0608080545, 0608080546, 0608080547, 0608080572, 0608080573,
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0608080666, 0608080667, 0608080688, 0608080736, 0608080737, 0608080738,
0608080739, 0608080772, 0608080773, 0608080774, 0608080793, 0608080794,
0608080795, 0608080796, 0608080813, 0608080814, 0608080815, 0608080904,
0608080905, 0608080906, 0608080907, 0608080934, 0608080935, 0608080994,
0608080995, 0608084591, 0608084592, 0608084593, 0608084594, 0608084595,
0608084596, 0608084597, 0608084598, 0609081739, 0609081740, 0609081741,
0609081797, 0609081798, 0609081799, 0609081800, 0609081801, 0609081810,
0609081811, 0609081823, 0609081824, 0609081841, 0609081842, 0610082025,
0610082026, 0610082027, 0610082028, 0610082029, 0610082030, 0610082031,
0610082032, 0610082033, 0610082034, 0610082035, 0610082036, 0610082037,
0610082038, 0610082039, 0610082110, 0610082111, 0610082112, 0610082113,
0610082114, 0610082115, 0610082154, 0610082155, 0610082156, 0610082157,
0610082158, 0610082159, 0610082228, 0610082229, 0610082230, 0610082276,
0610082277, 0610082280, 0610082310, 0610082311, 0610082312, 0610082313,
0610082377, 0610082378, 0610082379, 0610082390, 0610082391, 0610082392,
0610082400, 0611080561, 0611080578, 0611080746, 0611080747, 0611080748,
0611080749, 0611080775, 0611080776, 0611080821, 0611080822, 0611080862,
0611080863, 0611080864, 0611080865, 0611080866, 0611080867, 0611080868,
0611080869, 0611080870, 0611080871, 0611080872, 0611080873, 0611080933,
0611080955, 0611080956, 0611080957, 0611080958, 0611080959, 0612081517,
0612081518, 0612081519, 0612081520, 0612081561, 0612081562, 0612081563,
0612081564, 0612081565, 0612081566, 0612081628, 0612081629, 0612081630,
0612081631, 0612081632, 0612081633, 0612081650, 0612081651, 0612081652,
0612081653, 0612081654, 0612081655, 0612081683, 0612081684, 0612081685,
0612081686, 0612081719, 0612081720, 0612081721, 0612081724, 0612081743,
0612081774, 0612081786, 0612081787, 0612081796, 0612081797, 0612081798,
0612081799, 0612081800, 0612081801, 0612081868, 0612081869, 0612081870,
0612081871, 0612081872, 0612081873, 0612081921, 0612081922, 0701089012,
0701089013, 0701089014, 0701089015, 0701089016, 0701089017, 0701089067,
0701089068, 0701089069, 0701089070, 0701089071, 0701089072, 0701090501,
0701090502, 0701090503, 0701090504, 0701090505, 0701090506, 0701090548,
0701090569, 0701090570, 0701090571, 0701090572, 0701090573, 0701090574,
0701090628, 0701090629, 0701090630, 0701090631, 0701090632, 0701090633,
0701090634, 0701090635, 0701090636, 0701090637, 0701090638, 0701090639,
0701090640, 0701090641, 0701090642, 0701090643, 0701090644, 0701090645,
0701090811, 0701090812, 0701090813, 0701090836, 0701090837, 0701090838,
0701090839, 0701090840, 0701090841, 0701090842, 0701090843, 0701090898,
0701090899, 0701090900, 0701090901, 0701090902, 0701090903, 0701090904,
0701090905, 0701090906, 0701090907, 0701090965, 0702097501, 0702097502,
0702097503, 0702097504, 0702097505, 0702097506, 0702097533, 0702097534,
0702097535, 0702097536, 0702097537, 0702097538, 0702097600, 0702097660,
0702097661, 0702097662, 0702097663, 0702097664, 0702097665, 0702097706,
0702097707, 0702097708, 0702097709, 0702097710, 0702097741, 0702097742,
0702097743, 0702097744, 0702097745, 0702097746, 0702097790, 0702097791,
0702097792, 0702097793, 0702097794, 0702097795, 0702097817, 0702097818,
0702097819, 0702097820, 0702097821, 0702097822, 0702097834, 0702097835,
0702097836, 0702097837, 0702097838, 0702097839, 0702097888, 0702097889,
0702097890, 0702097891, 0702097892, 0702097893, 0702097917, 0702097918,
0702097919, 0702097920, 0702097921, 0702097922, 0703094502, 0703094503,
0703094505, 0703094506, 0703094507, 0703094508, 0703094543, 0703094545,
0703094546, 0703094598, 0703094599, 0703094600, 0703094601, 0703094602,
0703094603, 0703094604, 0703094605, 0703094606, 0703094607, 0703094608,
0703094609, 0703094610, 0703094648, 0703094677, 0703094678, 0703094679,
0703094680, 0703094681, 0703094682, 0703094755, 0703094756, 0703094757,
0703094758, 0703094759, 0703094760, 0703094862, 0703094863, 0703094864,
0703094865, 0703094866, 0703094867, 0703094888, 0703094889, 0703094897,
0703094898, 0703094899, 0703094900, 0703094901, 0703094903, 0703094923,
0703094924, 0703094925, 0703094926, 0703094927, 0703094928, 0703094943,
0703094944, 0703094945, 0703094946, 0703094947, 0703094980, 0703094981,
0703094982, 0703094996, 0703094997, 0703094998, 0703094999, 0704096516,
0704096517, 0704096518, 0704096519, 0704096529, 0704096530, 0704096531,
0704096532, 0704096554, 0704096555, 0704096556, 0704096557, 0704096574,
0704096575, 0704096576, 0704096583, 0704096584, 0704096585, 0704096586,
0704096623 and 0704096643
RECALLING
FIRM/MANUFACTURER Stryker Medical Div. of Stryker Corporation,
Portage, MI
REASON The internal power cord may become
damaged due to wear and, if this occurs, a shock hazard
exists.
VOLUME OF PRODUCT IN COMMERCE 1048 (1009 in the
U.S. plus 39 international)
DISTRIBUTION Nationwide,
Latin America, Mexico and Spain
PRODUCT Newport
HT50 Ventilator (all Models),
CODE All models, all serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Newport Medical Instruments Inc., Costa Mesa, CA,
Manufacturer: Flight Medical
Ltd., Lod, Israel.
REASON Battery Life: With use over time, the internal battery begins losing its
ability to hold a charge resulting in shortened ventilator operation time.
Specifically, Newport has received a number of reports concerning the internal
battery not lasting as long as expected followed by ventilator shut down with
less advance warning than when the battery was new.
VOLUME OF PRODUCT
IN COMMERCE 8,160
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT IVF
Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of
30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL,
CODE
Lot # 160306022 EXP 1/22/2010 160306046
EXP 2/15/2010 160306065 EXP 3/6/2010
RECALLING
FIRM/MANUFACTURER Humagen Fertility Diagnostics, Inc.,
Charlottesville, VA
REASON Pasteur pipettes for
laboratory use were labeled as sterile but may have become
contaminated.
VOLUME OF PRODUCT IN COMMERCE 160
boxes
DISTRIBUTION IL, UK, Greece, Australia, United Arab
Emirates, the Netherlands, and
Israel
PRODUCT LTX
XP Miniplant, Dental Implant, Sterile, Model No. LTX3211 and Model No. LTX3213,
CODE
Lot No. 606199 and Lot No.
606191
RECALLING FIRM/MANUFACTURER Biomet 3i, Palm Beach
Gardens, FL, by e-mail and fax letter on August 3, 2007. Firm initiated recall
is ongoing.
REASON The LTX XP Miniplant, BIOMET 3i dental
implant, was labeled incorrectly. The 13MM implants were labeled and packaged as
11.5MM implants and 11.5MM implants were labeled and packaged as 13MM
implants.
VOLUME OF PRODUCT IN COMMERCE 240 parts (120
parts per
lot)
DISTRIBUTION Internationally
PRODUCT ARCHITECT
Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL
bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with
protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin
MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES
buffer with protein (bovine) stabilizers; list 6C27-05,
CODE
Lot 82900M
RECALLING
FIRM/MANUFACTURER Abbott Laboratories MPG, Abbott Park, IL,
Manufacturer:
Bio-Rad Diagnostics Group,
Irvine, CA.
REASON The Architect Prolactin MasterChecks may
not be stable at the recommended storage conditions of 2 to 8 degrees C through
the expiration dating (15 months). The MasterChecks may exceed the suggested
tolerance limits listed in the Reportable Range/Calibration Verification section
in Appendix B of the Architect iSystem Operations Manual.
VOLUME OF
PRODUCT IN COMMERCE 57
kits
DISTRIBUTION Nationwide and
Canada
PRODUCT BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used
during electroencephalography (EEG) /Epilepsy Monitoring evaluations with
various EEG monitoring systems. The MicroJack is used with BMSI Models 2000,
3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with
NicoletOne,
CODE Models BMSI 2000,
3000, 4000, 5000 & 6000 and BMSI kit upgraded with NicoletOne, marketed
prior to May 2007.
RECALLING FIRM/MANUFACTURER Nicolet
Biomedical Div of Viasys Healthcare, Madison, WI
REASON The BMSI
"MicroJack" patient interface electrode connection device used with the EEG
monitor systems was found to be mis-wired. A complainant alleged that during
depth electrode EEG study of a patient in preparation for brain surgery there
was an observation that was perceived as non-logical data
output.
VOLUME OF PRODUCT IN COMMERCE 2,102
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT ReliOn
0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for
subcutaneous injection of insulin, Catalog number 326743,
CODE Batch number 6297350
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company,
Franklin Lakes, NJ,
Manufacturer: BD
Medical - Diabetes Care, Holdrege, NB.
REASON Complaints received indicating open seals
on blister paks, potentially compromising the sterility of the
product.
VOLUME OF PRODUCT IN COMMERCE 644,500
units
DISTRIBUTION Nationwide
PRODUCT Medtronic
Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use
by 2009-07-31. Different components and tubing sets are included within the
Custom Pack depending on customer requirements. Tubing sets are placed within a
plastic tray, which then is wrapped and placed inside a header bag and sealed at
the plastic side. This bag serves as the product sterile barrier,
CODE
Catalogue# / lot #: 3608/7626621,
CB2E25R7/7760483, CB2E28R/7760491, CB4Q86R/7226272, 9156R2/8105907,
1D41R10/7372026, 1F61R4 / 7038360, 1E04R7 / 7277651, 9156R2 / 8105907, 1X37R /
7760774, 3608 / 7626621, 0X01R7 / 7278478, 2567R41/ 6577695, 1E97R2 / 7828564,
5G01R / 7734883, CB5305R1 / 7346602, CB4Q86R / 7226272, 2T10R1 / 7252235, 1D91R1
/ 7843300, 1A45R3 /7584969, 3M16R5 / 7411494, CB2J35R3 / 7352341, CB3R62R /
7668062, 4V60R / 7934463, DLP2X90R /7504957, 3608 /7626621, 3608/ 7626621,
3C86R9/ 7656387, 3608/ 7626621, 3608/ 7626621, HY2K51R14/ 7438662, 2H08R2/
7668273, 3608/ 7626621, 1A05R15/ 7038597, CB4826R3 / 7843481, 3608/ 7626621,
TL4K84R7/ 7900108, CB3K45R6/ 7626276, 9295R2/ 7934447, 2100R3/ 7694869, CB3U51R7
/ 7695001, 9156R2/ 8105907, 9182R3/ 7694914, 0M14R12/ 7694762, 2C50R/ 7760791,
3608/ 7626621, 2K98R1/ 7668290, CB0U83R11/ 7721206, 2997R27/ 7438443, 9156R2/
8105907, TL3E97R5/ 7722225, TL4J32R8/ 7761048, 2Z75R5/ 7960821, CB2E25R7
/7760483, 4W91R/ 7843431, 3608/ 7626621, 9156R2/ 8105907, 1G69R7/ 7760715, 3608/
7626621, 2T28R1/ 7899872, 9156R2/ 8105907, 1F77R3/ 7722348, 1F77R3/ 7722348,
1F77R3/ 7722348, DLP4X54R/ 7761021, 3608/ 7626621, 3608/
7626621
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Medtronic Perfusion Systems, Brooklyn Park, MN,
Manufacturer: Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja
California, Mexico.
REASON Medtronic Custom Tubing Packs might have open
header bag seals.
VOLUME OF PRODUCT IN COMMERCE 853
units
DISTRIBUTION Nationwide
PRODUCT NxStage
Cartridge Express, CAR-170, for hemodialysis, CODE
Lot Numbers: 7037802, 703803, 703804,
7047702, 7047703, 7047704, 7047705, 7057702, 7057703, 7057704, 7057705, 7057706,
7057707, 7057708, 7057709, 7067701, 7067702,7067703, 7067705, 7067709, 7067710,
7067711, 7067712, 7067713, 7067714, 7067715, 7077703
RECALLING
FIRM/MANUFACTURER
Recalling Firm: NxStage Medical, Inc.,
Lawrence, MA,
Manufacturer: Medimexico,
S. de R.L. de C.V., Tijuana, Mexico.
REASON Potential for dialysate leaks from the cartridge
during treatment.
VOLUME OF PRODUCT IN COMMERCE 12,085
cases
DISTRIBUTION Nationwide
PRODUCT Guidewire,
70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Product Code
5583705,
CODE Lot Numbers: 22FMA202,
22IMO531, 22KMO573, 22DN2914, 22FN5232, 22GN5835, 22GN5878, 22HN6574, 22BO6078,
22BO6163, 22FO6086, 22GO6026, 22HO6101, 22IO6111, 22KO6124, 22CP6268, 22EP6831,
REPG0035, REPG0643, REPH0954, REPK0058, REPK0729, REPL0298, REQB0030, REQB0224,
REQD0200, REQF0429, REQF0736, REQJ0282, REQK0875, RERC0052,
RERD0719
RECALLING FIRM/MANUFACTURER Bard Access Systems,
Inc., Salt Lake City, UT
REASON Metal guidewires used in Hemodialysis
Catheters may have been reverse loaded within the dispenser. Potential exists
for the stiff end of the guidewire to be inserted into the patient instead of
the flexible end.
VOLUME OF PRODUCT IN COMMERCE 7,225
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Stryker
Radius Locking Caps, Catalog Number: 486610000, CODE Lot: 06C516, 06C358, 06C515, 06C581,
06C447, 06C579, 06C446, 06C467, 06A858 and 06C357
RECALLING
FIRM/MANUFACTURER Stryker Spine, Allendale, NJ
REASON
Product dissembled in the tray or prior
to being loaded onto the inserter or tightening on the rod.
VOLUME OF
PRODUCT IN COMMERCE 1,300 U.S.; 123
Italy
DISTRIBUTION Nationwide and Italy
PRODUCT 5mm
x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog
Number 5620-530,
CODE Serial
numbers: 0028-05, 0035-05, 0069-05, and 0092-05
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Mentor Texas, Inc.,
Irving, TX,
Manufacturer: Misonix, Inc.,
Farmingdale, NY.
REASON Mis-identified and mis-labeled surgical
probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration
Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix
5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number
5610-530.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION Nationwide
PRODUCT 25-Hydroxyvitamin
D 125 I RIA Kit, in vitro diagnostic. REF:68100E,
CODE Lot # 119604A
RECALLING
FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN,
REASON
25 Hydroxyvitamin D RIA kits may contain
the incorrect lot of tracer.
VOLUME OF PRODUCT IN
COMMERCE 117 kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT BCI
Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers: 340400,
3404001, and 3404002
CODE Catalog
number/Serial number: 3404001/AI05110052/ AI05120000/ AI051200