MARCH 2010
WEEK ENDING MARCH 27
PRODUCT
1) MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access
Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier
Precautions for use with 7 - 7.5 Fr Catheters. The product is shipped in cases
containing 5 catheters (contains Q-Syte). Product number ASK-21242-UVA2.
2) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte). Product number ASK-29803-SJH.
3) Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte). Product number ASK-42703-SJH.
4) Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte). Product number ASK-42802-SHB.
5) Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte); Product number ASK-45703-SHB.
6) Multi-Lumen Central Venous
Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter,
Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte).
CODE
1) Lot numbers RF9068459 and RF9060775;
2) Lot numbers RF9044900 and RF9068155;
3) Lot numbers RF9055789 and RF9071896;
4) Lot numbers: RF9068926;
5) Lot numbers: RF9071258 and RF9069621;
6) Lot numbers: RF9056115, RF9056743, and RF9060775
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA,
REASON Q-Syte Component contained in kits was recalled by manufacturer due to the
potential for embolism if used with a central venous catheter.
VOLUME OF PRODUCT IN COMMERCE
530 kits
DISTRIBUTION
GA, MD, VA
PRODUCT
Pump Fill Kit DT10175. Contents: 1 CSR Wrap, 2 Gloves, 1 Fenestrated Drape, 1
Extension Line Approx. Priming Vol.: 0.3mL, 1 Syringe, 1 Needle, 1 CholoraPrep(R),
1 TRAY The recalled Exel Huber Needles are used to access subcutaneously
implanted ports used for the withdrawal of blood samples and infusion of
medication. The firm places the recalled needles in pump fill kit.
CODE
Lot numbers: 911127, 901218, 908258, 2008091590, 2008111790, 2009011290,
2009062290, 2009090790, 2009100590 and 2009112390
RECALLING FIRM/MANUFACTURER
Recalling Firm: Centurion Medical Products, Howell, MI,
Manufacturer: Exelint International Co., Culver City, CA.
REASON
The needles that are labeled as non-coring could core 60-72% of the time.
VOLUME OF PRODUCT IN COMMERCE
880 kits
DISTRIBUTION
Nationwide
PRODUCT
Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile; REF
904842P. Intended to be implanted for fixation of bone fractures and for bone
reconstructions.
CODE
All lots. Lot Numbers: 006120, 006130, 006150, 310980, 457500, 457510, 457520,
528050, 549180, 597000, 597010, 689520, 689530, 689540, 843100, 843140, 933310
and 933320
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, .
Manufacturer: Biomet Sports Medicine, Ontario, CA.
REASON
Anchors may be difficult to remove, or may not detach from the inserter shaft.
VOLUME OF PRODUCT IN COMMERCE
894 units
DISTRIBUTION
Nationwide and Belgium
PRODUCT
1) Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912,
917 and Modular P; Catalog no. 03800504190. The product is used for in vitro
diagnostic reagent for the quantitative determination of gentamicin in human
serum or plasma on automated clinical chemistry analyzers.
2) Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
3) Roche/Hitachi GENT2 ONLINE TDM
Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190. The
product is used for in vitro diagnostic reagent for the quantitative
determination of gentamicin in human serum or plasma on automated clinical
chemistry analyzers.
CODE
1) Lot Numbers: 15617800, 15622600, 15616900 and 15621900;
2) Lot Numbers 15622600, 15617800, 15616900 and 15816200;
3) Lot Numbers 15621900, 15617800, 15622600, 15616900, 15816200 and 15815600
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN,
REASON
A high recovery of the assay may be generated, which would lead to an
underdosage of gentamicin being administered to the patient.
VOLUME OF PRODUCT IN COMMERCE
13,187 kits
DISTRIBUTION
Nationwide
PRODUCT
Oxoid CM0225 Brain Heart Infusion IVD. The product is used for the cultivation
of streptococci, pneumococci, meningococci and other fastidious organisms and is
suitable for blood culture work.
CODE
Lot numbers: 762134, Exp. 2014.04.30; 793640, Exp. 2014.07.31; and 819693, Exp.
2014.10.31
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remel, Inc., Lenexa, KS,
Manufacturer: Oxoid, Ltd., Basingstoke, United Kingdom.
REASON
Product failure - Failure to grow quality control strains of Streptococcus
pneumoniae.
VOLUME OF PRODUCT IN COMMERCE
105 bottles
DISTRIBUTION
FL, NY, MO, DE, PA
PRODUCT
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C.
CODE
Lot numbers: 25310 and 25831
RECALLING FIRM/MANUFACTURER
Mainline Technology, Inc., Ann Arbor, MI,
REASON
Lack of assurance of safety and efficacy: unapproved for marketing in the U.S.,
non-compliance with cGMP regulations and no stability data to support labeled
expirations dates.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide, Belgium and Switzerland
PRODUCT
1) Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set;
Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging,
Catalog # HC902-SAM-911. The product is used for the quantitative determination
of calcium in serum on Hitachi analyzers.
2) Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
3) Calcium (CPC) R2 Reagent Set. Pointe
Scientific Liquid Calcium (CPC) R2 Reagent Set; Catalog #'s HC402-R2. Calcium
CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. The product is
used for the quantitative determination of calcium in serum on Hitachi
analyzers.
CODE
All lots containing 813401 as part of the lot number
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI,
REASON
Non-compliance with the Good Manufacturing Practice regulations, as the
manufacturing process for this product had not been validated.
VOLUME OF PRODUCT IN COMMERCE
54 sets plus 30 L
DISTRIBUTION
Nationwide, Chile, India, Republic of Yemen and Trinidad
PRODUCT
Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures
Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile; REF
00-5954-057-02. The product is used as an implant for knee replacement.
CODE
All lots. Lots 00111134, 60747593, 60747594, 60752676, 60752677, 60760248,
60768076, 60821507, 60824004, 60830411, 60830412, 60845351, 60850604, 60852670,
60852671, 60860895, 60866613, 60872311, 60879050, 60892605, 60900745, 60907449,
60917234, 60922494, 60938889, 60938890, 60947027, 60947028, 60963035, 60963036,
60963037, 60963039, 60983254, 61015851, 61028168, 61033723, 61033724, 61068387,
61068388, 61068389, 61074754, 61074755, 61084771, 61096604, 61116246, 61116247,
61137056, 61143427, 61149041, 61157940, 61173295, 61193516, 61193520, 61198179,
61204038, 61215644, 61225562, 61235612, 61240323, 61248321, 61259184, 61263170,
61272449, 61285508, 61298201, 61306497, 61280371, 61315873, 61319581 and
61329266
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN,
REASON
The titanium portion of the implant may separate from the trabecular metal
material.
VOLUME OF PRODUCT IN COMMERCE
846 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, Denmark, France, Germany,
Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.
PRODUCT
Hill-Rom TotalCare Bed; Model P1900. The product is used as an AC powered
adjustable hospital bed.
CODE
Serial numbers K285AM5539 through K310AM5864. Serial numbers K310AM5857 ,
K296AM5635 , K296AM5629 , K295AM5623 , K306AM5779 , K306AM5777 , K303AM5747 ,
K303AM5741 , K300AM5677 , K300AM5675 , K299AM5654 , K299AM5651 , K302AM5718 ,
K301AM5715 , K301AM5712 , K301AM5710 , K301AM5709 , K301AM5707 , K301AM5705 ,
K301AM5704 , K301AM5702 , K301AM5700 , K301AM5696 , K301AM5695 , K300AM5693 ,
K300AM5690 , K300AM5686 , K300AM5682 , K299AM5660 , K299AM5653 , K296AM5647 ,
K296AM5643 , K299AM5656 , K299AM5652 , K302AM5725 , K302AM5723 , K302AM5719 ,
K301AM5714 , K301AM5698 , K300AM5688 , K299AM5663 , K299AM5658 , K302AM5735 ,
K302AM5733 , K302AM5731 , K302AM5729 , K302AM5726 , K302AM5724 , K302AM5722 ,
K302AM5720 , K302AM5716 , K301AM5713 , K301AM5708 , K301AM5706 , K300AM5691 ,
K294AM5594 , K303AM5761 , K303AM5748 , K303AM5739 , K303AM5760 , K303AM5759 ,
K303AM5758 , K303AM5757 , K303AM5756 , K303AM5755 , K303AM5754 , K303AM5753 ,
K303AM5752 , K303AM5751 , K303AM5750 , K303AM5749 , K303AM5738 , K296AM5648 ,
K296AM5645 , K296AM5642 , K306AM5780 , K306AM5776 , K303AM5740 , K302AM5737 ,
K302AM5734 , K302AM5732 , K302AM5730 , K302AM5728 , K302AM5721 , K300AM5678 ,
K300AM5676 , K300AM5674 , K299AM5669 , K299AM5666 , K299AM5665 , K299AM5662 ,
K296AM5644 , K296AM5641 , K296AM5639 , K296AM5637 , K296AM5631 , K295AM5619 ,
K308AM5812 , K307AM5797 , K306AM5775 , K306AM5772 , K306AM5771 , K306AM5770 ,
K306AM5769 , K306AM5768 , K306AM5767 , K306AM5766 , K306AM5765 , K306AM5764 ,
K306AM5763 , K299AM5671 , K299AM5668 , K299AM5667 , K299AM5664 , K299AM5661 ,
K299AM5659 , K299AM5655 , K303AM5746 , K303AM5745 , K303AM5744 , K303AM5742 ,
K294AM5599 , K294AM5584 , K300AM5687 , K300AM5692 , K300AM5689 , K300AM5685 ,
K300AM5683 , K300AM5673 , K299AM5670 , K302AM5727 , K294AM5595 , K294AM5593 ,
K294AM5591 , K294AM5590 , K294AM5587 , K299AM5650 , K296AM5649 , K296AM5640 ,
K296AM5638 , K296AM5636 , K296AM5634 , K296AM5630 , K296AM5628 , K295AM5625 ,
K295AM5624 , K295AM5622 , K295AM5621 , K295AM5620 , K295AM5618 , K295AM5616 ,
K295AM5614 , K295AM5612 , K295AM5611 , K295AM5609 , K295AM5607 , K294AM5605 ,
K294AM5604 , K294AM5600 , K294AM5596 , K294AM5586 , K294AM5585 , K294AM5583 ,
K294AM5582 , K294AM5579 , K294AM5578 , K299AM5589 , K294AM5601 , K294AM5598 ,
K294AM5603 , K294AM5592 , K302AM5717 , K301AM5711 , K301AM5699 , K301AM5697 ,
K300AM5684 , K300AM5672 , K301AM5703 , K301AM5701 , K296AM5646 , K294AM5588 ,
K294AM5581 , K294AM5580 , K296AM5633 and K295AM5627
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc, Batesville, IN
REASON
The controls for nurse call, bed movement and entertainment functions on the
intermediate rail may fail to function.
VOLUME OF PRODUCT IN COMMERCE
185 units
DISTRIBUTION
Australia, Canada, France, Germany, Mexico, United Arab Emirates and United
Kingdom
PRODUCT Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number
21-2145-01 only for use with Smiths Medical CADD®-Solis ambulatory infusion
pumps, Model 2100. These cords were sold as an accessory for these pumps under
Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403. Electri-Cord
AC Power Cords are accessories for use with the CADD®-Solis Ambulatory Infusion
Pump. These power cords allow users to run the pump via AC power rather than
battery power. The CADD®-Solis pump is indicated for intravenous,
intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves,
into an intraoperative site (soft tissue, body cavity/ surgical wound site),
epidural space, or subarachnoid space infusion. The pump is intended for
therapies that require a continuous rate of infusion, patient-controlled demand
doses, or both.
CODE
Lot # 0068858-1-1
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN,
REASON
Potential for the power cord's prongs to crack and fail at/or inside the plug.
Other medical device manufacturers have reported incidents of sparking,
charring, and fires from the affected power cords used with their devices.
Smiths Medical has received no reports of incidents regarding the use of the
affected Electri-Cord power cords with their devices.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
KY, OH and Canada
PRODUCT
1) Femoral Sponge 10 inches REF 206-715, Rx Sterile. The femoral sponge is an
absorbent that is used to dry the intramedullary canal prior to the application
of bone cement. The suction effectively absorbs blood and fluid from the canal.
It may provide swabbing/scrubbing action during suction.
2) Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF 206-730, Rx, Sterile. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
3) Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile, REF 306-563S10. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
4) ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
5) ACM Bio-Prep with Merocel pkg/6, Rx,
Sterile, REF 0306-708-000S4. The femoral sponge is an absorbent that is used to
dry the intramedullary canal prior to the application of bone cement. The
suction effectively absorbs blood and fluid from the canal. It may provide
swabbing/scrubbing action during suction.
CODE
1) Lot numbers: 743288, 743289, 743330, 743331, 743332, 743333, 743362, 743363,
743364, 743365, 743378, 743379, 743380, 743381, 743390, 743391, 743400, 743402,
743403, 743404, 743405, 743418, 743419, 743420, 743421, 743422, 743423, 743445,
743446, 743447, 743448 and 743449;
2) Lot numbers: 04230CE2, 04257CE2, 04286CE2, 04310CE2, 04334CE2, 05004CE2, 05041CE2, 05109CE2, 05200012, 05222012, 05292012, 05346012, 06038012, 06128012, 06172012, 06241012, 06268012, 06313012, 06348012, 07022012, 07031012, 07053012, 07081012, 07106012, 07136012, 07177012, 07192012, 07219012, 07253012, 07276012, 07320012, 07341012, 08010012, 08043012, 08063012, 08095012, 08127012, 08162012, 08177012, 08203012, 08249012, 08296012, 08325012, 08351012, 09040012, 09075012, 09106012 and 09138012;
3) Lot numbers: 06292012, 07297012, 07354012 and 08164012;
4) 4) Lot number: 05068CS2 and 05210012;
5) Lot numbers: 05257012 and 08129012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI,
Manufacturer: Hydrofera, LLC, Willimantic, CT. and Stryker Puerto Rico,
LTD, Arroyo, PR.
REASON
The firm did not have packaging validation to support the labeled shelf life.
There is potential for a breach in sterility specific to the sterile packaged
femoral sponge which may result in a non-sterile product.
VOLUME OF PRODUCT IN COMMERCE
9,257 units
DISTRIBUTION
Nationwide, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands,
England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain,
and Italy
PRODUCT
PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple
beam radiation therapy treatments.
CODE
Lot numbers: 0800690C208F, 0800690C2228, 0800690C934D. 080069107C11,
08006907BB7F, 08006907B074, 08006907B129, 08006907BB7D, 0800690E964F,
0800690EA07F, 08006909355C, 08006902E7CF, 08006907BEE0, 08006909DA0F,
0800690A4565, 080069100F06, 080069103003, 080069103015, 080069103265,
08006910326F, 08006907B051, 08006910178B, 0800690A9B6B, 0800690A466D,
08006908EFB4, 080069090A10, 0800690977C2, 08006909D8DE, 08006909D8DA,
0800690937B1, 08006908EDF3, 0800690A02F6, 0800690ABEC5, 0800690761D4,
0800690C2229, 0800690AC55A, 0800690A2865, 0800690A25BA, 0800690AB1EE,
080069087078, 0800690883D0, 0800690E984E, 08006905C04D, 0800690A02F3,
0800690A47CF, 0800690C1E5A, 0800690EAE97, 08006906D9B0, 08006906D94E,
0800691050D5, 0800690AB49C, 0800690C9357, 0800690AC0A3, 0800690ABEE0,
0800690C1DF2, 0800690C21B1, 0800690ABF4D, 0800690A0FE1, 080069AB4C1,
0800690906AE, 08006907F138, 08006909F10F, 080069090953, 080069EC1DD,
0800690883CB, 0800690A0FF6, 0800690A0FEF, 0800690C9148, 0800690A8793,
0800690A02F5, 08006902E9E0, 08006902E7D1, 0800690C9B7B, 08006902E7F8,
0800690E8CA9, 08006902EA0A, 0800690E7279, 0800690761D1, 0800690841C6,
08006908ED1C, 080069105594, 0800690C0D48, 0800691064DE, 080069087740,
0800690937BB, 080069090260, 08006907CA1C, 08006905E180, 08006905E6BA,
0800690ED67D, 08009607D4EF, 08006907D6B8, 08006907BB82, 08006910762B,
08006910762A, 08006907BB8E, 08006902E7F0, 080069077BB7, 0800690C54B2,
0800690A73DA, 08006909FA29, 0800690978E3, 08006907CA22, 08006907999A,
0800690CECEA, 0800690CDF04, 0800690909AB, 08006902E925, 08006910001E,
08006910623A, 08006910624F, 080069079BB3, 0800690761CF, 08006907DADE,
0800690E72DF, 08006908A3A8, 0800690A02FD, 08006902EB35, 0800691003D7,
080069107262, 0800690E7F53, 08006909D80B, 08006905E498, 08006905E63C,
0800690A0BA5, 0800690ED72E, 0800690ED90E, 08006905A8E6,
080069086F94,0800690883CD, 080069088319, 0800690EBC3A, 0800690EBBFF,
0800690EBFCA, 0800690A8830, 0800690A8841, 080069076231, 08006907622F,
0800690C90F4, 08006902E918, 080069107342, 080069088273, 08006909F50B,
0800690977ED, 08006907C7A1, 080069076BF4, 0800690C9B17, 0800690C2B4E,
08006905C433, 08006905BE74, 08006905E723, 08006905A225, 0800690883C8,
08006909673B, 0800690C9AA2, 08006907BB7E, 08006907023, 08006908706A,
08006909F1BB, 08006909EFA6, 080069099D13, 0800690A2863, 0800690A0FE4,
08006908847A, 080069088463, 0800690A0FE5, 08006909F507, 0800690CED1C,
08006907BEDF, 08006905BA2D, 0800690CE165, 08006905EB6E, 080069087A27,
0800690C6356, 0800690E9F8A, 0800690E9AB7, 0800690E82C4, 0800690E7283,
0800690EADC5, 0800690EACE8, 0800690EA40C, 0800690EA365, 080069099D0A,
080069086F92, 0800691077E0, 0800690C2168, 080069090841, 08006908F51D,
080069086630, 0800690907F5, 0800690907CD, 080069104115, 0800690A854C,
0800690A4677, 0800690A37AE, 080069106B53, 08006910816B, 0800690EAFCF,
0800690CDDA2, 0800690E72F7, 08006909FD0C, 08006909FD1B, 0800690A4670,
08006907BB89, 0800690A9DOE, 0800690A87F2, 08006907BB55, 0800690840A8,
080069087720, 080069076227, 08006908EC10, 0800690937B9, 0800690BD8A4,
080069132DDF, 080069134331, 0800691048A5, 0800690A2507, 0800690E9A67,
0800690A85E1, 0800690A8F4C, 0800690A1438, 0800690A13FB, 0800690A90FD,
0800690E6CF9, 080069102A57, 0800690EC864, 0800690909B4, 080069A0FE2,
0800690A8E1F, 080069100F95, 080069098EF6, 0800690C1745, 08006909D95A,
0800690A740E, 0800690A7410, 0800690AC55B, 0800690ACA88, 08006909D93B,
080069097A4D, 080069097A4E, 0800690A02FC, 0800690A47CE, 0800690A47E5,
0800690A47AE, 0800691050AF, 0800690A97D1, 0800690A1DC6, 08006907BEB2,
0800690A8F6D, 0800690A8F4F, 0800690EAF6D, 0800690EB40C, 08006907BB6D,
0800690CF7A2, 0800691003C3, 080069100455, 0800690ED7DF, 0800690CE157,
0800690EB787, 0800690ED7CO, 08006910560F, 08006910561E, 080069105607,
0800690ED967, 080069106136, 0800691075FB, 080069107C1F, 080069108174,
08006910762C, 0800690F6E74, 08006902E8DB, 0800690A85FB, 0800690949E1,
080069107CB2, 80069104499, 80069100706, 0800690C1E69, 08006910621E, 0049434409
and 1116245379
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA,
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), West Sussex, UK.
REASON
The new "DICOM CT with Body Outline" method to create a patient case
in PrecisePLAN 2.15 may produce incorrect results for some customers, given
several input conditions encountered in the field. Discontinue use of this
method of creating a patient case until FCO 772 00 540 064, (entitled
"Update for Patient creation method using DICOM CT with Body
Outline"), is received from Elekta to update this utility. This problem
only applies to customers using the "DICOM CT with Body Outline"
method of creating a patient case and this option is only available in release
2.15 of PrecisePLAN. The "DICOM CT" method in release 2.15 and
previous releases of PrecisePLAN is not affected by this problem (see User
Manual section 3.2.2). The Field Change Order details the prerequisites and
installation instructions for upgrading PrecisePLAN users to the new release,
2.16 (Linux customers) or 2.12 (SGI customers).
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
Nationwide and France
PRODUCT
The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer
(model 300). The i-STAT Analyzer is used by trained medical professionals for
running a variety of clinical chemistry tests and test panels contained in i-STAT
test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen,
sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon
dioxide, and pH), Creatinine, lactate and activated clotting time. List number
06F23-91/111300; Abbott list number: 06F23-91.
CODE
Serial numbers between 20091081 and 241248976
RECALLING FIRM/MANUFACTURER
Abbott Point of Care, Inc., Princeton, NJ,
REASON
Some Martel Printers used with the i-STAT 1 system have the potential of being
damaged due to the use or rechargeable battery packs that do not contain a fuse.
VOLUME OF PRODUCT IN COMMERCE
5,224 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL
and HeartStart MRx monitor/defibrillators) Models: M4741A - Extra Large Switched
internal Paddles M4742A - Large Switched internal Paddles M4743A - Medium
Switched internal Paddles M4744A - Small Switched internal Paddles.
CODE
Units with date codes (mmyy) of 0908, 1008, 1108, 1208 (Units manufactured by
Philips between September 1, 2008 and December 30, 2008)
RECALLING FIRM/MANUFACTURER
Philips Healthcare, Inc., Andover, MA,
REASON
Paddle shock switch may fail to actuate and delay or prevent delivery of
defibrillation therapy.
VOLUME OF PRODUCT IN COMMERCE
1,592 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
PTS Panels Lipids Panel test strips for self-testing or professional use with
CardioChek P-A analyzers; Catalog # 1710.
CODE
Lot number: P814; exp. 9/2/09
RECALLING FIRM/MANUFACTURER
Polymer Technology Systems, Inc., Indianapolis, IN,
REASON
Exhibits under-recovery of all analytes.
VOLUME OF PRODUCT IN COMMERCE
Not available
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) Modified Novy Cornual Cannulation Set with clear tip, G17558, REF
J-NCS-504070, Cook OB/GYN.
2) Modified Novy Cornual Cannulation
Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GYN.
CODE
1) Units: U1707021, U1716443, U1718282, U1718283, U1721655, U1739397, U1752842,
U1755314, U1755769, U1834419, U1834420, U1834421, UF1748711, UF1758368, and
UF1758369;
2) Units: U1705449, U1707347, U1709250,
U1711011, U1714331, U1734602, U1737151, U1743919, U1746659, U1746660, U1755767,
U1772781, U1772782, U1791573, U1792176, U1793188, U1799467, U1825725, U1825726,
U1841365, U1862710 and U1863536
RECALLING FIRM/MANUFACTURER
Cook Women’s Health, Spencer, IN,
REASON
The distal tip may separate from the catheter while the catheter is in the
patient.
VOLUME OF PRODUCT IN COMMERCE
721 units
DISTRIBUTION
Nationwide, Ireland, China, Canada, India, Australia, Hong Kong
PRODUCT
remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402,
10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile
swab. Product is a sterile system recommended for use in qualitative procedures
for the collection of clinical specimens and transport to the laboratory for
microbiological culture of anaerobic, facultative, and aerobic organisms.
CODE
Lot number: 834019, Exp. 2010.10.27
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS,
REASON
Pouch may be inadequately heat sealed compromising sterility.
VOLUME OF PRODUCT IN COMMERCE
154/10-package containers
DISTRIBUTION
Nationwide
PRODUCT
Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.
No expiration dates.
CODE
Lot numbers: 568229, 568588, 568784, 569128, 620731, 621058, 621143, 621453,
621608, 622599, 622890
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConvaTec, Skillman, NJ,
Manufacturer: Unomedical, Ltd. Stonehouse, Glos, UK.
REASON
Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the
order code 3405M, and boxes labeled with order code 3405M may contain a cable
for order code 3508M.
VOLUME OF PRODUCT IN COMMERCE
1,270 cables
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Ventana Pathway anti-Her-2/NEU (4B5) Rabbit Monoclonal Primary Antibody (Pathway
HER2 (4B5); Model Number: 790-2991, in vitro diagnostic.
CODE
Lot number: 680957
RECALLING FIRM/MANUFACTURER
Ventana Medical Systems, Inc., Tucson, AZ,
REASON
Light staining inconsistencies.
VOLUME OF PRODUCT IN COMMERCE
433 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50
mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease
Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity
1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210.
invitro diagnostic. Recall # Z-1147-2010;2) Paraffin Pretreatment Reagent Kit
III; each kit contains the following: 5 x 50 mL Pretreatment Solution (1N sodium
thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5
mM Calcium Chloride - 2H2O 0.1% SDS), 5 x 9.0 mg Protease III (Proteinase K, 35
<= x <= 38 Units/mg) 2 x 200 mL Protease Stop Solution (0.01N hydrochloric
acid - HCl); Abbott Molecular Inc; list 07J02-003, part number 32-801230.
invitro diagnostic.
CODE
1) Lot numbers: 420563, 420008 and 418294;
2) Lot numbers: 420063 and 418669
RECALLING FIRM/MANUFACTURER
Abbott Molecular, Des Plaines, IL,
REASON
The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS
information included in their labeling.
VOLUME OF PRODUCT IN COMMERCE
322 kits
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of
various polymeric filling materials (composites) used with other conditioners or
combination of conditioners for bonding of composite to metal including amalgam,
gold, semi-precious and non-precious alloys, porcelain and glass and luting of
same to Dentin and Enamel.
CODE
Lot numbers: 186620, 190582 and 190985
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybron Dental Specialties, Orange, CA,
Manufacturer: Pentron Clinical Technologies, Wallingford, CT.
REASON
Some of the material has been found to be gelled and therefore becomes unusable.
VOLUME OF PRODUCT IN COMMERCE
1,400 units
DISTRIBUTION
Nationwide, Canada, Netherlands, Sweden, Taiwan and Thailand
PRODUCT
Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with
the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer,
Catalog No. 400-0028. Medical device for use in the in vitro quantitative
determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase
(ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose,
potassium, sodium, total bilirubin, total carbon dioxide, total protein, and
blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.
CODE
Lot number: 9284AC2, accidentally labeled as 9285AC2, Exp. Date 7/9/2010
RECALLING FIRM/MANUFACTURER
Abaxis, Inc., Union City, CA,
REASON
Wrong barcode applied to a lot of items, which may result in incorrect
calibration factors and results.
VOLUME OF PRODUCT IN COMMERCE
1,010 units
DISTRIBUTION
Nationwide, Canada, EU and Asia
PRODUCT
Elekta SL Series/Precise Digital Accelerator. The product is used with radiation
therapy treatment of malignant neoplastic diseases, as determined by a licensed
medical practitioner. a) Model SL15; b) Model SL18; c) Model SL25; d) Model
PRECISE ACC; e) Model SYNERGY PLAT; f) Model SL20; g) Model SL75/5; h) Model
SL1+; i) Model SL1; j) Model SL75/20.
CODE
a) Serial Nos. 105102, 105333, 105481, 105279, 1054424, 105325, 105364, 105387,
105291, 105280, 105261, 105297, 105355, 105386, 105342, 105367; b) Serial Nos.
105213, 105392, 105395, 105326, 105203, 105369, 105284, 105153, 105166, 105324,
105265, 105320, 105177, 105305, 105122, 105199, 105359, 105366, 105126, 105363,
105178, 105233; c) Serial Nos. 105013, 105204, 105245, 105373, 105376, 105275,
105277, 105127, 105196, 105393, 105186, 105217, 105210, 105117, 105137,
105215105194, 105195, 105228, 105236, 105235, 105104, 105240, 105368; d) Serial
Nos. 105992, 105894, 105563, 105806, 105902, 105627, 105706, 105785, 105821,
105871, 105648, 105655, 105882, 105960, 105754, 105886, 105606, 105585, 105731,
105989, 105727, 105782, 151075, 151077, 151098, 105841, 151099, 105630, 151014,
105895, 105816, 105864, 105846, 1055559, 105657, 105853, 105854, 105829, 151016,
105660, 105844, 105890, 105621, 105587, 151035, 105580, 105809, 105644, 105593,
105705, 105699, 105803, 105723, 105647, 105898, 105369, 105949, 105868, 105998,
105637, 105837, 105636, 105716, 105717, 151029, 105759, 105770, 105772, 105776,
105925, 105568, 105650, 105591, 105929, 105584, 105624, 105941, 105666, 108573,
105926, 105646, 105676, 105260, 105773, 105936, 105872, 105678, 151159, 151030,
105910, 105969, 151015, 105812, 105796, 105950, 105881, 105859, 105728, 105561,
105590, 105612, 105567, 105744, 105566, 105879, 105828, 105856, 105918, 105555,
105610, 105883, 105914, 105990, 105586, 151154, 105649, 105565, 105564; e)
Serial Nos. 151033, 151216, 151173, 151053, 105826, 151200, 151201, 151116,
151025, 151160, 105982, 151256, 151076, 151110, 151008, 151093, 151229, 105932,
151143, 151038, 151059, 151260, 151130, 151024, 151214, 151167, 151051, 151176,
151080, 151104, 151259, 151238, 151084, 105984, 151155, 151156, 151157, 151074,
151266, 151134, 151141, 151055, 151073, 151178, 151168, 151151; f) Serial Nos.
105285, 105093, 105321, 105358, 105286, 105295, 105249, 105274, 105288, 105381,
105403, 105323, 105319, 105312, 105316, 105257, 105267, 105207, 105057, 105351,
105327, 105273, 105185, 105339, 105300, 105187, 105382, 105154; g) Serial Nos.
103137, 103172, 103174, 103092, 103091, 103130, 103131, 103124, 103394, 103099,
103159, 103081, 103384, 103026, 103053, 103050, 103110, 103001, 103177, 103161,
103030, 103084, 103064, 103055, 103154, 103399, 103346, 103375, 103027, 103386;
h) Serial Nos. 105447, 105465, 105518, 105528, 105514, 105478, 105466, 105519,
105498, 105453, 105492, 105467, 105445, 105452; i) Serial Nos. 105475, 105521,
105549, 105494, 105437, 105503, 105530, 105544, 105488, 105515, 105482, 105532;
j) Serial Nos. 273, 266, 269, 274
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA,
Manufacturer: Elkta Oncology Systems (Fmrl Phillipps), Crawley, West Sussex, UK.
REASON
Customer reported larger than expected variations in wedge factory with gantry
rotation.
VOLUME OF PRODUCT IN COMMERCE
315 units
DISTRIBUTION
Nationwide, Canada, Mexico
PRODUCT
Thermoflect Product Line including items for adults and pediatrics.
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Encompass Group LLC, McDonough, GA
Manufacturer: Encompass Therapeutic Support Systems dba BG - North America,
Glendale, CA..
REASON
The products are not compatible for use in the Magnetic Resonance Imaging (MRI)
environment.
VOLUME OF PRODUCT IN COMMERCE
700,000 units (of various product lines)
DISTRIBUTION
Nationwide and Switzerland
PRODUCT
Image Consultant (IC) Software.
CODE
Not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: R. O. Golden & Co., Inc., Elkins Park, PA,
Manufacturer: Unique Media, Canton, PA.
REASON
Software not validated.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, WA
PRODUCT
PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A
test systems; Catalog No. 1753. For the quantitative measurement of LDL
cholesterol in whole blood.
CODE
Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008
RECALLING FIRM/MANUFACTURER
Polymer Technology Systems, Inc., Indianapolis, IN
REASON
The expiration date was extended by 20 weeks without justification.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Internationally
PRODUCT BIO-RAD 425-2020 Autoimmune EIA
Anti-Cardiolipin IgM, 96 Tests...2010 02 16.
Positive Control included in lot is identified as "REF 425-2025". in
vitro diagnostic.
CODE
LOT CL-863; LOT CPM-591
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA,
REASON
The firm received customer complaints of microbial contamination in Positive
Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863v.
VOLUME OF PRODUCT IN COMMERCE
213 units
DISTRIBUTION
Nationwide, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore,
and Trinidad
WEEK ENDING MARCH 20
PRODUCT
1) Baxter HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A;
Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R. The
HomeChoice dialysis system is a personal cycler automated peritoneal dialysis
system for pediatric and adult renal patients with fill volumes ranging from 60
mL to 3000 mL.
2) HomeChoice PRO Automated Peritoneal
Dialysis Systems; Made in U.S.A.; Catalog Numbers; 5C8310, 5C8310R, R5C8320,
R5C8320R, T5C8300, and T5C8300R. The HomeChoice dialysis system is a personal
cycler automated peritoneal dialysis system for pediatric and adult renal
patients with fill volumes ranging from 60 mL to 3000 mL. The HomeChoice PRO
model has a PRO card, a small electronic data card, which stores information
from the nurse or doctor and automatically sets up the system for the patient
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL,
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. F
REASON
Potential overfill of the peritoneal cavity, also referred to as Increased
Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death.
VOLUME OF PRODUCT IN COMMERCE
94,076 units
DISTRIBUTION
Nationwide, Austria, Australia, Belgium, Brazil, Canada, Chile, China, Columbia,
Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq,
Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico,
Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland,
Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore, Slovenia, Spain,
Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates,
United Kingdom and Venezuela
PRODUCT i-STAT 1 Analyzer, Product of USA. The product is intended to be used by trained
medical professionals for use with i-STAT test cartridges and MediSense blood
glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry
tests and test panels. Catalog number 06F16-10.
CODE
No lot or serial numbers
RECALLING FIRM/MANUFACTURER
Abbott Point of Care, Inc., Princeton, NJ,
REASON
The storage temperature on the label on the side of the i-Stat Portable Clinical
Analyzer shipping box does not match product specification.
VOLUME OF PRODUCT IN COMMERCE
3,918 analyzers
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not
Sterile; Intended for use in the non-cervical spine.
CODE
Lot number: A91109
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ,
Manufacturer: Stryker Spine, Aquitane, France.
REASON
The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of
Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide
PRODUCT
Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
CODE
All lots
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA,
REASON
There is the potential for the bender/cutter attachment to continue heating
after release of the power button. There is potential for patient and/or staff
injury if continuous heating is unrecognized.
VOLUME OF PRODUCT IN COMMERCE
187 units
DISTRIBUTION
Nationwide
PRODUCT
1) Stryker T2 Ankle Arthrodesis Nail, left; 010 x 300 mm; Catalog number
18181030S; Sterile, TI Alloy; Intended for tibiotalocalcaneal arthrodesis
(fusion) and to provide stabilization of the hindfoot and ankle including the
transverse tarsal joints coupling the mid-foot to the hindfoot.
2) Stryker T2 Ankle Arthrodesis Nail, left; 011 x 300 mm; Catalog Number: 18181130S; Sterile, TI Alloy. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
3) Stryker T2 Ankle Arthrodesis Nail, left; 012 x 300 mm; Catalog number: 18181230S; Sterile, TI Alloy. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
4) Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S; Sterile, TI Alloy. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
5) Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S; Sterile, TI Alloy. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
6) Stryker T2 Ankle Arthrodesis Nail,
right; 012 x 300 mm; Catalog number: 18191230S; Sterile, TI Alloy; Intended for
tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the
hindfoot and ankle including the transverse tarsal joints coupling the mid-foot
to the hindfoot.
CODE
1) Lot codes: K152966, K177319, K208221, K230272, K254574, K735537, K779942,
K841062, K842726, K868798, K868816, K883947, and K892961;
2) Lot codes: K152966, K177319, K208221, K230272, K254574, K735537, K779942, K841062, K842726, K868798, K868816, K883947, and K892961;
3) Lot codes: K163646, K192333, K236971, K472870, K733121, K776754, K785625, K842732, K868822, K875207, K893039, and K977374;
4) Lot codes: K101051, K157119, K185536, K210257, K549634, K735538, K769105, K779949, K837690, K868843, and K893064;
5) Lot codes: K125357, K158792, K185537, K199852, K227392, K452805, K455652, K461353, K624000, K732800, K769107, K782950, K785627, K820525, K858019, K863219, K868858, K893086, K951620, K963944, and K983458;
6) Lot codes: K108843, K152964,
K171685, K180561, K194187, K227390, K253168, K733141, K776745, K785626, K785652,
K802766, K831465, K837694, K868868, and K999298
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, .
Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany.
REASON
Stryker Orthopedics became aware that there is the potential for damage to the
sterile packaging of the product during transport.
VOLUME OF PRODUCT IN COMMERCE
702 units
DISTRIBUTION
Nationwide
PRODUCT
1) Coulter LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide
and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended
for use as an optional peripheral to the Beckman Coulter LH 700 Series System.
Creates a blood smear on a clean microscope slide using a segment of the blood
sample aspirated by the LH 700 Series.
2) GEN*S SlideMaker, Barcode Label
Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers
6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional
peripheral to the COULTER GEN*S System. Creates a blood smear on a clean
microscope slide using a segment of the blood sample aspirated by the GEN*S
System.
CODE
All Software Versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: Beckman Coulter Inc., Fullerton, CA.
REASON
The Sample ID information embedded in the barcode affixed to a slide made by the
Coulter GEN*S and LH SlideMaker does not match the text.
VOLUME OF PRODUCT IN COMMERCE
847 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
1) Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol
Reagent Set; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent
Set, (Clinical chemistry). For the quantitative determination of high density
lipoprotein (HDL) in cholesterol in serum.
2) Liquid HDL (PEG) Cholesterol
Reagent; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry). For
the quantitative determination of high density lipoprotein (HDL) in cholesterol
in serum.
CODE
All lots containing the numbers 815701 in the lot number.
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI,
REASON
The firm initiated the recall due to the presence of visible contamination of
the product.
VOLUME OF PRODUCT IN COMMERCE
616 sets plus 9 L
DISTRIBUTION
Nationwide, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua,
Nigeria, Philippines, Poland, Sri Lanka and Trinidad
PRODUCT
Variant II Turbo Hemoglobin A1c Program, model number 270 2417. Intended Use:
For the percent determination of hemoglobin A1c in human whole blood using
ion-exchange high-performance liquid chromatography (HPLC).
CODE
Lot Number: 70291520
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA,
REASON
Product update kit CD rom will not upload. As a result, the device cannot be
run.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
Nationwide, Hong Kong, New Zealand
PRODUCT
PTS Panels Cholesterol test strips for self-testing or professional use with
CardioChek analyzers, Catalog # 1711. Intended to provide a quantitative
measurement of total cholesterol in whole blood.
CODE
Lot Number: C908
RECALLING FIRM/MANUFACTURER
Polymer Technology Systems, Inc., Indianapolis, IN.,
REASON
The memory chip was coded with incorrect product information.
VOLUME OF PRODUCT IN COMMERCE
486 vials
DISTRIBUTION
Nationwide
PRODUCT
1) Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics,
multiple sizes. Intended for use in cementless fixation fro use in total hip
arthroplasty to relieve pain and restore function in the hip.
2) Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes. Intended to be used with femoral components in primary or revision total knee arthroplasty.
3) Scorpio X3 UHMPWE Tibial Inserts and
Scorpio X3 UHMWPE Patellar Components, multiple sizes. Intended to be used with
cemented or cementless components in primary or revision total knee arthroplasty.
R
CODE
1) Lot Numbers: 36481101; 36491201; 36514901; 36609101; 36517801; 36526201;
36602201; 36422401; 36631201; 36643801; 36425501; 36448901; 36647201; 36737701;
36742301; 36772901; 36775301; 36547101; 36563001; 36473901; 36738101; 36609001;
36466401; 36642601; 36481401 and 36428401;
2) Lot Numbers: 36325001; 36325102;36325302; 36325402; 36325602; 36326002; 36326201;33936308; 36605501; 36326601; 33934303; 33934705; 36327201; 36327301; 36327401; 36328101; 35453302; 36378501; 36604001; 36379001; 36379101; 36379201; 36379301; 36379401; 36604301; 36379501; 36604502; 36379901; 36326301; 36380001; 36380101; 35728201; 36380401; 36380601; 36380901; 36381201; 36381401; 35730101; 36381601; 35730602; 35921201; 35921301; 36382001; 35730801; 35730802; 35730803 and 36382101;
3) Lot Numbers: 35458101; 36121101;
36121401; 36209601; 36209701; 35904301; 35904501; 35904701; 36294401; 36297801;
36605701; 36297902; 36605801; 35904901; 36298101; 35905001; 36298201; 35905101;
35905301; 36295101; 35905501; 36298801; 36298902; 36299301; 35906001; 36007001;
36301001; 36007101; 36301301; 36862701; 36011001; 36606201; 36606401; 36011801;
36301501; 36012201; 36012301; 36301901; 36012901; 36302001; 36013001; 36013401;
36302101; 36302301; 36014501; 36014701A 36014801; V145; V146; V148; V161; V162;
V163; V165; V166; V024C and V026C
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ,
REASON
A potential anomaly related to the packaging process of referenced lots of X#
polyethylene used on Scorpio, Triathlon and Trident inserts.
VOLUME OF PRODUCT IN COMMERCE
594 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
1) Pointe Scientific Uric Acid (Liquid) Reagent Set; Catalog # HU782-246 and
HU982-615. For the quantitative determination of uric acid in serum on Hitachi
analyzers. For in-vitro diagnostic use only.
2) Pointe Scientific Liquid Uric Acid
(R1) Reagent Set; Catalog # HU482-R1. For the quantitative determination of uric
acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
CODE
All lot numbers containing the numbers 918301; exp. 2011-01.
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI,
REASON
A process deviation occurred during the production of the R1 component which may
affect its performance.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CA, FL, KY, MI, OH, OK, VA, Chili and Malaysia
PRODUCT
Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems,
UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access
Clinical Systems. Intended to be used with the Access Immunoassay System to
remove waste from the system. Pump Part Numbers A62712, A62839, A62840, A62841,
and A63124; Instrument Part Numbers: 973100, A30260, and A59102.
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: Beckman Coulter Inc., Fullerton, CA.
REASON
A new premature failure of the upper aspirate peristaltic pump in the systems
listed above. Premature failure of the pump may negatively affect precision. The
failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which
have a pump identified with one of the new pump manufacturing numbers (Mfg.
Nos.) listed above. The upper peristaltic pump assembly may not maintain a
proper flow rate.
VOLUME OF PRODUCT IN COMMERCE
114 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
Sealapex Express, Part Number: 33639, root canal filling material. Intended as a
root canal filling material that is used in conjunction with gutta percha or
silver endodontic points.
CODE
Lot Numbers: 6-1314, 7-1221 and 7-1258
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybron Dental Specialties, Orange, CA,
Manufacturer: Sybron Dental Specialties Inc., Glendora, CA.
REASON
Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to
the presence of crystals in the catalyst. This crystallization may affect proper
canal filling by preventing Gutta Percha Points from reaching the bottom of the
root canal which may lead to an inadequate seal.
VOLUME OF PRODUCT IN COMMERCE
1,309
DISTRIBUTION
Nationwide, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany,
Spain, France, UK, Greece, Italy, Kuwait, Lebanon, Portugal, Russia, Sweden,
Hong Kong, India, Malaysia and Taiwan
PRODUCT
OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per
pouch, packaged in a box with a specimen cup and instructions for use, 12 boxes
per case; a rapid colorimetric indicator for the qualitative changes (ferning)
of salt content in saliva to aid in the prediction of ovulation; Manufacturer: A
rapid saliva indicator for the qualitative prediction of favorable and
unfavorable fertile days in women's menstrual cycles. UPC 8 50877 00055 5.
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quest Products, Libertyville, IL,
Manufacturer: Integrated Biomedical Technology, Inc., Elkhart, IN.
REASON
The ovulation test strips were shipped without 510(k) premarket notification
clearance from the FDA.
VOLUME OF PRODUCT IN COMMERCE
3,930 cases
DISTRIBUTION
Nationwide
PRODUCT
"K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for
use on automated clinical chemistry analyzers by laboratories. It is used for
the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying
C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin)
samples. It is for in vitro diagnostic use. Catalog number:
"KAI-084C".
CODE
Lot # 559011
RECALLING FIRM/MANUFACTURER
Kamiya Biomedical Co., LLC, Tukwila, WA,
REASON
The long-term stability of level 2 (1.0 mg/dL) may not be within the
specifications due to a decrease in CRP concentration.
VOLUME OF PRODUCT IN COMMERCE
3 kits
DISTRIBUTION
NY, NJ, NC
PRODUCT
1) Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml.
bottles and a 6x100-ml. bottle package. This medium facilitates rapid recovery
of viable mononuclear cells from small volumes of blood. The Histopaque-1077
procedure is suitable for studying cell-mediated lympholysis and for human
lymphocyte antigen (HLA) typing. It may also be employed as the initial
isolation step prior to enumeration of T-, B- and "null lymphocytes.
2) Sigma-Aldrich Histopaque-1119, Ref.
11191, packaged in 100- ml. bottles and 6x100-ml. bottle packages. The product
is for use in separating mononuclear cells and granulocytes when used with
Histopaque-1077.
CODE
1) Lot numbers: 037K6141, 037K6300, 047K6015, 069K6086, 087K6015, 088K6035, and
107K6201;
2) Lot numbers: 038K6030, 126K6002, and 079K6047
RECALLING FIRM/MANUFACTURER
Sigma-Aldrich Mfg LLC, Saint Louis, MO,
REASON
Instructions for Use (IFU) was revised to recommend sterile filtering of the
product under certain circumstances.
VOLUME OF PRODUCT IN COMMERCE
1077 - 11,015/100-ml bottles, 5,745/6/100-ml bottle packages, and 14,872/500-ml
bottles; 1119 - 8,640/100-ml bottles and 3,138/6/100-ml. bottle packages
DISTRIBUTION
Nationwide, Canada, Mexico, United Arab Emirate, Australia, Bolivia, Brazil,
Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Ecuador,
France, Great Britain, Hong Kong, Israel, India, Italy, Jamaica, Japan, Korea,
Panama, Peru, Paraguay, Saudi Arabia, Singapore, Thailand, West Indies, Taiwan,
Venezuela, and South Africa
PRODUCT
Herculite Ultra (Part Number 34333), dental composite resorative material.
CODE
Lot Number: 3161098
RECALLING FIRM/MANUFACTURER
Sybron Dental Specialties, Orange, CA,
REASON
Sybron Dental Specialties is initiating a field correction on the Herculite
Ultra, a dental composite restorative material, due to a mistake in the
directions for use located in the Herculite technique card.
VOLUME OF PRODUCT IN COMMERCE
442 units
DISTRIBUTION
Nationwide
WEEK ENDING MARCH 13
PRODUCT
1) BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100.
2) BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101.
3) BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102.
4) BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108.
5) MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150.
6) MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151.
7) MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164.
8) BD Nexiva Closed IV Catheter System, REF 383530, 24GA 0.56IN.
9) BD Nexiva Closed IV Catheter System, REF 383531, 24GA 0.75IN.
10) BD Nexiva Closed IV Catheter System, REF 383532, 22GA 1.00IN.
11) BD Nexiva Closed IV Catheter System, REF 383533, 20GA 1.00IN.
12) BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN.
13) BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN.
14) BD Nexiva HF Closed IV Catheter System, REF 383537, 20GA 1.25IN.
15) BD Nexiva Closed IV Catheter System, REF 383538, 20GA 1.75IN.
16) BD Nexiva Closed IV Catheter System, REF 383539, 18GA 1.25IN.
17) BD Nexiva Closed IV Catheter System, REF 383540, 18GA 1.75IN.
18) BD Nexiva Closed IV Catheter System, REF 383647, 20GA 1.25IN.
19) BD Nexiva Closed IV Catheter
System, REF 383649, 18GA 1.25IN.
CODE
1) Lot Numbers 8268863, 8269020, 8275798, 8308321, 8308323, 8309553, 8331937,
8331940, 8354558, 9007921, 9009643, 9009646, 9028838, 9035029, 99035032;
2) Lot numbers: 8305510, 8331944;
3) Lot numbers: 8305511, 8308330,
8354561, 9012072;
4) Lot numbers: 9007918, 9035042, 9035044;
5) Lot numbers: A1967, A1979, A2056;
6) Lot numbers: A1950, A2399;
7) Lot number: A1951;
8) Lot numbers: 8238450, 8319936, 8345957, 9013868;
9) Lot numbers: 8284049, 8284050, 8305438, 8308349, 8345951, 9013867, 9026722;
10) Lot numbers: 8248349, 8259950, 8295761, 8296792, 8296793, 8309299, 8309662, 8311150, 8319961, 8322609, 8331771, 8338737, 8338738, 8358628, 9020033;
11) Lot numbers: 8291980, 8330279;
12) Lot number: 8331763;
13) Lot number: 8248355, 8249034, 8249035, 8269338, 8270576, 8274565, 8275207, 8275210, 8283964, 8311167, 8312211, 8319016, 8347056, 9007360, 9015539, 9022039;
14) Lot numbers: 8263294, 8270579, 8347058, 9013864;
15) Lot number: 8312220;
16) Lot number: 8263293, 8274555, 8275429, 8290311, 8340308, 9016819;
17) Lot number: 8340302;
18) Lot Number: 9034319;
19) Lot Number: 9041552
RECALLING FIRM/MANUFACTURER
Becton Dickinson Medical Systems, Sandy, UT, b
REASON Manufacturing defect may allow air entry into a central
venous catheter, possibly resulting in an air embolism.
VOLUME OF PRODUCT IN COMMERCE
1,275,200 units (Q-Syte US), 2,651,680 units (Nexiva)
DISTRIBUTION Nationwide
PRODUCT
1) AC power cords used with either Bair Paws Temperature Management Units:
Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505,
750 and 775 Indicated for hyper- or hypothermic patients or normothermic
patients, for whom induced hyper- hypothermia or localized temperature therapy
is clinically indicated. In addition, the temperature management systems can be
used to provide patient thermal comfort when conditions exist that may cause
patients to become too warm or too cold. The temperature management system can
be used with adult and pediatric patients.
2) AC power cords used with Ranger Blood/Fluid Warming Unit: Model 245. Intended to warm blood, blood products and liquids. Part number 502221 Model 90024.
3) AC power cords used with Ranger Irrigation Fluid Warming Unit; Model 247. Intended to warm irrigation fluids. Part number 502221 Model 90024.
4) AC power cords used with Ranger
Pressure Infusion Power Pack; Model 90033. To provide power to pressure
infusers. Part number 502221 Model 90024. CODE None
RECALLING FIRM/MANUFACTURER
Arizant Inc., Eden Prairie, MN
REASON This recall is being issued in response to a small
number of customer reports of melting, smoking or fire within the power cord
plug. However, the potential risks from this power cord failure include electric
shock, delay in setup and therapy, interruption of therapy, device failure, and
fires.
VOLUME OF PRODUCT IN COMMERCE 84,537 nationwide; 7,380
internationally
DISTRIBUTION Nationwide and Internationally
PRODUCT NextGen Knee
Gender Solutions CR-Flex Femoral Component, Precoat, Size D, Left.
00-5750-014-01.
CODE Lot number: 61369812
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN,
REASON The package should contain the left knee component but
actually contains the right knee component. Delay in completing surgery may
result, and a new or different implant may need to be identified.
VOLUME OF PRODUCT IN COMMERCE 14 units
DISTRIBUTION Nationwide, Korea
PRODUCT
1) 9200 Advisor Vital Signs Monitor utilizes the power cord WW3005.
2) BCI 3180 Pulse Oximeter utilizes the power cord WW3005.
3) 8400 Capnocheck Capnometer utilizes
the power cord 8404 for its battery charger 330.
CODE
1) Power cord # WW3005;
2) Power cord # WW3005;
3) Power cord # 8404
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI,
REASON Smiths Medical is conducting a voluntary recall of a
limited number of medical device AC power cords, manufactured by Electri-Cord
Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor
Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or
Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected
Electri-Cord AC power cords are equipped with a plug that has prong and
ground-pin insert design and a black plastic bridge connecting the terminal
prongs on the plug. The FDA has reported that two medical device manufactures
have reported incidents of sparking, charring, and fires from the affected power
cords used with their devices. Smiths medical has received no reports of
incidents regarding the use of the affected Electric-Cord power cords with their
devices.
VOLUME OF PRODUCT IN COMMERCE 1358 cords for all devices
DISTRIBUTION Nationwide, and Internationally
PRODUCT
1) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDICAL/TIGHT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422221, FOR CEMENTED USE ONLY, QTY: (1), STERILE.
2) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422222, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
3) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM, M/L 27 MM, REF 71422223, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
4) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422224, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
5) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422225, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
6) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422226, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
7) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422232, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
8) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422233, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
9) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422234, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
10) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422235, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
11) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422236, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
12) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422241, QTY: (1), STERILE EO.
13) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422243, QTY: (1), STERILE EO.
14) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422244, QTY: (1), STERILE EO.
15) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422245, QTY: (1), STERILE EO.
16) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422246, QTY: (1), STERILE EO.
17) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422247, QTY: (1), STERILE EO.
18) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422248, QTY: (1), STERILE EO.
19) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422251, QTY: (1), STERILE EO.
20) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422252, QTY: (1), STERILE EO.
21) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422253, QTY: (1), STERILE EO.
22) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422254, QTY: (1), STERILE EO.
23) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422255, QTY: (1), STERILE EO.
24) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422256, QTY: (1), STERILE EO.
25) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422257, QTY: (1), STERILE EO.
26) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422258, QTY: (1), STERILE EO.
27) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422261, QTY: (1), STERILE EO.
28) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422262, QTY: (1), STERILE EO.
29) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422263, QTY: (1), STERILE EO.
30) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422264, QTY: (1), STERILE EO.
31) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422265, QTY: (1), STERILE EO.
32) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422266, QTY: (1), STERILE EO.
33) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422267, QTY: (1), STERILE EO.
34) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422268, QTY: (1), STERILE EO.
35) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933296, QTY: (1), STERILE EO.
36) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933297, QTY: (1), STERILE EO.
37) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933298, QTY: (1), STERILE EO.
38) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933299, QTY: (1), STERILE EO.
39) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933300, QTY: (1), STERILE EO.
40) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933301, QTY: (1), STERILE EO.
41) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933302, QTY: (1), STERILE EO.
42) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933303, QTY: (1), STERILE EO.
43) JOURNEY " UNI TIBIAL BASEPLATE RIGHT MEDIAL/ LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422231, FOR CEMENTED USE ONLY, QTY: (1), STERILE.
44) JOURNEY " UNI TIBIAL INSERT
LEFT MEDIAL/ LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422242, Qty: (1), Sterile
EO.
CODE All lot numbers
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN,
REASON The firm has received complaints of the base plates
breaking in situ. If a breakage occurs, the broken base plate must be revised
and/or changed. If left unrevised a broken base could lead to instability and
premature wear of the construct.
VOLUME OF PRODUCT IN COMMERCE 38,750 units
DISTRIBUTION Nationwide, Argentina, Switzerland, Australia,
Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany,
Malaysia, Portugal, Netherlands, Singapore, and England
PRODUCT BD Probetec"
ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap,
Catalog number 440476, packed in shelfpack unit of 100 swabs.
CODE Lot 7016132, Exp date 01/17/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD,
Manufacturer: Becton Dickinson Vascular Access S.A. de C.V., Nogales,
Sonora, Mexico.
REASON Product was shipped beyond its expiration date.
VOLUME OF PRODUCT IN COMMERCE 242 packages
DISTRIBUTION Nationwide and Australia
PRODUCT Sigma-Aldrich
Histopaque-1077, Ref. 10771, packaged in 500-ml. bottles. This medium
facilitates rapid recovery of viable mononuclear cells from small volumes of
blood. The Histopaque-1077 procedure is suitable for studying cell-mediated
lympholysis and for human lymphocyte antigen (HLA) typing. It may also be
employed as the initial isolation step prior to enumeration of T-, B- and
"null" lymphocytes. CODE Lot #038K6170, Exp. 2011-04
RECALLING FIRM/MANUFACTURER
Sigma-Aldrich Mfg LLC, Saint Louis, MO,
REASON Some of the product was contaminated with Pseudomonas
mendocina.
VOLUME OF PRODUCT IN COMMERCE 6,808/500-ml. bottles
DISTRIBUTION Nationwide, Great Britain, France, China, Germany,
Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong,
Peru, Taiwan, and Venezuela
PRODUCT Dimension
Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro
diagnostic.
CODE Lot number 09061AA exp 2010-03-02
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE
REASON Incorrect result: patient sample BUN results reported
may be higher or lower than actual level.
VOLUME OF PRODUCT IN COMMERCE 1,254 cartons
DISTRIBUTION Nationwide, Australia, Canada, Germany, Japan, and
Korea
PRODUCT
1) SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N,
P49230-D and P49234.
2) SmartBlock Pain Management System,
Part numbers P49524, P49534, P49624, and P49634. CODE All
models and all lot codes in the USA received 1/1/2007 through 1/22/2009;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hsmg, Inc., D/b/a Smartinfuser USA, Houston, TX,
Manufacturer: Medical Flow Systems, LTD, Shlomi, Israel.
REASON Product leaks associated with a new pump reservoir, and
incident related to regulator fast priming feature.
VOLUME OF PRODUCT IN COMMERCE 6,837 units
DISTRIBUTION Nationwide
PRODUCT
1) Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL.
2) Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL.
3) Exacta Mix TPN (total parenteral
nutrition) Bag, Model 740, 2000.
CODE
1) Lot numbers: 738391, 738392;
2) Lot Numbers: 736779, 736780, 738175, 738176, 738254;
3) Lot Numbers: 735020, 735134, 735135,
735136, 735137, 735138, 735139, 737607, 738007
RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO
REASON TPN bags may leak fluid due to inadequate sealing.
VOLUME OF PRODUCT IN COMMERCE 5,513 cases (US) 353 cases
(International)
DISTRIBUTION Nationwide, Argentina, Australia, Bermuda, Brazil,
Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand,
Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay
PRODUCT Teleflex
Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers:
425-00, 425-10 and 525-30.
CODE All lot and serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Telefelx Medical, Durham, NC,
Manufacturer: Teleflex Medical, Inc., Tecate, B.C., Mexico.
REASON When turned on, the Neptune heater may cause an artifact
on the patient's heart monitor.
VOLUME OF PRODUCT IN COMMERCE 15,134 units
DISTRIBUTION Nationwide, Canada, India, Japan, Puerto Rico,
Germany, France, Italy and Ireland
Teleflex Incorporated Announces Recall of Arrow Select IV Tubing Sets, Accessories, and Certain Embolectomy Catheters
Teleflex Incorporated is recalling ALL lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010.
Testing revealed pin holes in some of the pouches in which the products are packaged, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death.
Consumers who have:
should STOP using and return the items to Arrow International. Customers can find the entire affected product list at www.teleflexmedical.com.
The affected product was distributed globally to healthcare institutions and distributors.
Customers with questions can contact the Arrow IV Tubing customer service hotline at 866-396-2111 between the hours of 8am and 8pm, ET, Monday through Friday.
WEEK ENDING MARCH 6
PRODUCT
1) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF
70129-204, 8 x 40, Sterile EO. Intended for palliation of malignant neoplasms in
the biliary tree.
2) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree.
3) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x 80, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree.
4) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x 40, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree.
5) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree.
6) Endotek Alimaxx-B Uncovered Biliary
Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO. Intended for
palliation of malignant neoplasms in the biliary tree. RCODE
1) Lot Numbers: F727578A and IML4466A;
2) Lot Numbers: F727579A and IML4457A;
3) Lot Numbers: F727580A and IML4456A;
4) Lot Numbers: F727581A, IML4481A and IML4482A;
5) Lot Numbers: F727582A, IML 4476A, IML4480A, IML4531A, IML 4573A and IML 4593A;
6) Lot Numbers: F727583A, IML4453A,
IML4487A, IML4488A and IML4533A
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT,
REASON Degradation of the outer portion of the delivery
catheter may prevent proper deployment of the biliary stent.
VOLUME OF PRODUCT IN COMMERCE 165 units
DISTRIBUTION Nationwide
PRODUCT
1) LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3
Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use
fluid path way for administration of I.V. fluids using the Symbiq infusion pump;
48 sets per case; list number 16096-28. List Number: 16096-28.
2) LifeShield Latex-free Primary I.V.
Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports,
piggyback with Option-Loc, attached extension set, 122 inch, 15 drops/mL; an Rx
sterile single use fluid path way for administration of I.V. fluids; 48 sets per
case; list number 19689-01; List Number: 19689-01.
CODE
1) Lot: 82-028-5H;
2) Lot Number: 81-147-5H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL,
Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia,
Costa Rica.
REASON There is a potential for fluid to leak from the
backcheck valve which could result in inaccurate delivery and occupational
exposure.
VOLUME OF PRODUCT IN COMMERCE 49,440 sets
DISTRIBUTION MN, UT
PRODUCT Locator
Restorative Abutment, ILOA002, Certain Locator Abutment, 4.1 mm(D) X 2mm(H),
Sterile. For use on tissue supported removable over-dentures on 2 to 4 implants,
partially edentulous overdentures with one or more implants, limited interarch
distance, angle correction with up to 40 degrees between divergent implants.
CODE Lot 877423
RECALLING FIRM/MANUFACTURER
Biomet 3i, LLC, Palm Beach Gardens, FL,
REASON Package labeled as sterile may have an incomplete or
partial seal thereby possibly compromising sterility.
VOLUME OF PRODUCT IN COMMERCE 97 units
DISTRIBUTION Nationwide, Middle East, Italy, Europe, and Greece
PRODUCT
Biphasic LIFEPAK 12 defibrillator / monitor. Part Number: LP12,
VLP12-02-(various dash numbers).
CODE
Serial Numbers (non-contiguous): 8529728, 8529728, 9210418, 9210419, 9599334,
10128750, 10132851, 10248200, 10389064, 11120818, 11244332, 11252979, 11252980,
11252981, 11289300, 11311777, 11311778, 11311782, 11311787, 11316922, 11372139,
11424301, 11424819, 11471546, 11568711, 11610477, 11766215, 11766216, 11766222,
11767531, 11767565, 11877154, 12007118, 12007124, 12007129, 12007131, 12007135,
12009524, 12009528, 12030152, 12209828, 12209830, 12209832, 12209834, 12551932,
12551934, 12551936, 12551937, 12551939, 12776733, 12776734, 12779439, 12779439,
12789243, 13165363, 13269232, 13423039, 13434816, 13434837, 13522303, 13536842,
13704769, 13704770, 13870608, 13993048, 14008074, 14008075, 14201185, 14201186,
14201187, 30646561, 32117838, 32117838, 32117839, 32117839, 32117840, 32117840,
37125611, 37125612, 37125617, 37125743, 37125751, 37125752, 37125753, 37126327,
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37126336, 37126342, 37126369, 37128467, 37128482, 37128485, 37128642, 37128643,
37128644, 37128646, 37128651, 37128652, 37128653, 37128660, 37128661, 37128662,
37128663, 37128666, 37128667, 37128668, 37128669, 37128670, 37128674, 37128678,
37135341, 37135394, 37135396, 37135397, 37135398, 37135418, 37135423, 37135424,
37135425, 37136603, 37136622, 37136623, 37136670, 37138749, 37138751, 37138756,
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37139187, 37139188, 37139189, 37139190, 37139191, 37139192, 37139193, 37139194,
37139202, 37139203, 37139204, 37139205, 37139206, 37139207, 37139252, 37139254,
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37148812, 37148863, 37148863, 37148864, 37148864, 37148865, 37148865, 37148867,
37148868, 37148868, 37148872, 37148878, 37148881, 37148881, 37148882, 37148882,
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37159272, 37159273, 37159329, 37159330, 37159334, 37159337, 37159338, 37159339,
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37205302, 37205303, 37205304, 37205305, 37205306, 37205307, 37205308, 37205309,
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37208519, 37208520, 37208521, 37208524, 37208527, 37208563, 37208564, 37208565,
37208566, 37208567, 37208568, 37208569, 37208570, 37208654, 37208655, 37208656,
37208712, 37208713, 37208714, 37208715, 37208716, 37208717, 37208722, 37208723,
37208724, 37208767, 37208768, 37211021, 37211041, 37211044, 37211045, 37211098,
37211099, 37211100, 37211386, 37211389, 37211392, 37211406, 37211414, 37211642,
37211643, 37211644, 37211645, 37211646, 37211647, 37211648, 37212070, 37212391,
37212409, 37212412, 37212414, 37212424, 37212429, 37212827, 37213069, 37213095,
37213129, 37213174, 37213188, 37213220, 37213249, 37213502, 37213503, 37213504,
37213505, 37213541, 37213542, 37213574, 37213575, 37213576, 37216010, 37216669,
37216670, 37216774, 37216775, 37216883, 37216884, 37216886, 37216905, 37216906,
37216907, 37216908, 37216911, 37216916, 37216934, 37217051, 37217190, 37217191,
37217192, 37217194, 37217198, 37217199, 37217203, 37219856, 37219882, 37219883,
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37220092, 37220210, 37220210, 37220211, 37220211, 37223009, 37223012, 37223036,
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37223199, 37223202, 37223203, 37223544, 37223545, 37224052, 37224063, 37224064,
37224134, 37224135, 37224142, 37224147, 37224148, 37224160, 37226315, 37226316,
37226330, 37226331, 37226332, 37226333, 37226334, 37226335, 37226336, 37226337,
37226338, 37226339, 37226348, 37226349, 37226350, 37226351, 37226352, 37226353,
37226410, 37226411, 37226412, 37226413, 37226416, 37226420, 37226511, 37231960,
37231961, 37232006, 37234694, 37234695, 37234696, 37234697, 37234698, 37234699,
37234700, 37234701, 37234702, 37234703, 37234704, 37234705, 37234706, 37234708,
37234709, 37234710, 37234711, 37234712, 37234746, 37235337, 37235338, 37235365,
37235368, 37237465, 37237552, 37237553, 37237554, 37237563, 37237571, 37237818,
37237821, 37237824, 37237825, 37240785, 37240792, 37240793, 37240794, 37240795,
37240796, 37240798, 37240799, 37240800, 37240801, 37240802, 37240803, 37240804,
37240805, 37240806, 37240808, 37240810, 37240811, 37240812, 37240813, 37241075,
37241087, 37241117, 37245319, 37245771, 37245772, 37245780, 37245781, 37246017,
37246018, 37246354, 37246355, 37246356, 37246493, 37246499, 37249345, 37250362,
37250365, 37250372, 37250375, 37250379, 37250382, 37259407, 37259408, 37259409,
37259410, 37259411, 37259412, 37259413, 37259414, 37259418, 37259420, 37259421,
37259422, 37259423, 37259424, 37259426, 37259427, 37259428, 37259429, 37259430,
37259434, 37259442, 37259450, 37259451, 37259455, 37259457, 37259460, 37259463,
37259644, 37259668, 37259933, 37260513, 37260525, 37260526, 37260527, 37260589,
37260590, 37260591, 37260594, 37260596, 37260600, 37260606, 37260617, 37260623,
37260630, 37263770, 37263771, 37263772, 37263773, 37263774, 37263874, 37263875,
37263876, 37263877, 37263878, 37263920, 37263922, 37263931, 37263941, 37263949,
37263950, 37263951, 37263952, 37263953, 37263954, 37263955, 37263956, 37264340,
37264341, 37264342, 37264345, 37264346, 37264347, 37264350, 37264351, 37264358,
37264365, 37264365, 37264374, 37264375, 37264376, 37264377, 37264378, 37264379,
37264698, 37264714, 37268732, 37268860, 37268861, 37268862, 37268863, 37268864,
37268865, 37268866, 37268878, 37268879, 37268880, 37268881, 37268882, 37268896,
37268898, 37268915, 37273926, 37274137, 37274138, 37274139, 37274140, 37274141,
37274142, 37274143, 37274144, 37274145, 37274146, 37274147, 37274148, 37274149,
37274150, 37274151, 37274152, 37274153, 37274154, 37274155, 37274156, 37274157,
37274158, 37274159, 37274160, 37274161, 37274162, 37274510, 37274511, 37274512,
37274513, 37274514, 37274515, 37274516, 37274517, 37275262, 37275272, 37275272,
37275273, 37275273, 37275274, 37275274, 37275275, 37275275, 37275282, 37275312,
37288407, 37288408, 37288409, 37288410, 37288411, 37288433, 37288453, 37288454,
37288455, 37288456, 37288474, 37288475, 37288478, 37288598, 37288603, 37288610,
37288614, 37288647, 37288649, 37288650, 37288653, 37288654, 37288655, 37288656,
37288657, 37288660, 37288661, 37288663, 37288664, 37288665, 37288666, 37288667,
37288668, 37288669, 37288670, 37288671, 37288672, 37288819, 37288821, 37288822,
37288823, 37288825, 37288826, 37288894, 37298226, 37298227, 37298229, 37298232,
37298236, 37298243, 37298246, 37305892, 37305897, 37305897, 37305901, 37305901,
37305902, 37305902, 37305903, 37305903, 37305904, 37305904, 37306051, 37306051,
37306052, 37306052, 37306053, 37306053, 37306054, 37306054, 37306058, 37306058,
37306059, 37306059, 37306455, 37306456, 37306457, 37306458, 37306459, 37306460,
37306461, 37306462, 37315264, 37357985, 37357986, 37357987, 37357988, 37357989,
37357990, 37357991, 37357992, 37357993, 37357994, 37358010, 37358011, 37358012,
37358020, 37358021, 37358026, 37358027, 37358028, 37358033, 37358035, 37358053,
37358066, 37358069, 37358070, 37358071, 37358074, 37358075, 37358082, 37358083,
37358116, 37358147, 37358150, 37358155, 37358158, 37358167, 37358204, 37358207,
37358235, 37358239, 37358241, 37358285, 37358286, 37358287, 37358449, 37358450,
37358451, 37358460, 37358463, 37358464, 37358465, 37358480, 37358481, 37358547,
37359127, 37359128, 37359129, 37359396, 37359410, 37359428, 37359487, 37359491,
37359495, 37359496, 37359497, 37359498, 37359499, 37359500, 37359501, 37359502,
37359503, 37359505, 37359506, 37359507, 37359508, 37359509, 37359510, 37359511,
37361533, 37361849, 37361883, 37361934, 37361935, 37361939, 37361940, 37361941,
37361947, 37362070, 37362071, 37362072, 37362265, 37362266, 37362270, 37362276,
37362281, 37362282, 37362286, 37362300, 37362301, 37362302, 37362302, 37362303,
37362304, 37362305, 37362941, 37362941, 37362942, 37362942, 37362968, 37362968,
37362976, 37362976, 37363070, 37363070, 37363071, 37363146, 37363213, 37363224,
37363224, 37363229, 37363231, 37363231, 37363234, 37363237, 37363249, 37363252,
37363456, 37363456, 37363465, 37363465, 37363466, 37363467, 37363467, 37363472,
37363486, 37363487, 37363494, 37363500, 37363629, 37363633, 37363635, 37363636,
37363637, 37363638, 37363650, 37365624, 37365631, 37365672, 37365676, 37365678,
37365679, 37365681, 37365682, 37365684, 37365698, 37365699, 37365704, 37365705,
37365706, 37365707, 37365708, 37365709, 37365712, 37365723, 37366277, 37366278,
37366282, 37366342, 37366816, 37366817, 37366984, 37366998, 37367004, 37367019,
37367025, 37367037, 37367063, 37367069, 37367328, 37367567, 37367582, 37367613,
37367615, 37367615, 37367621, 37367622, 37367623, 37367624, 37367625, 37370902,
37370903, 37370914, 37370915, 37370919, 37370922, 37370925, 37370928, 37370929,
37370930, 37370931, 37370942, 37371050, 37371092, 37371096, 37371099, 37371101,
37371104, 37371107, 37371116, 37371118, 37371122, 37371123, 37371130, 37371131,
37371133, 37371134, 37371134, 37371135, 37371135, 37371136, 37371137, 37371139,
37371154, 37371155, 37371159, 37371164, 37371165, 37371174, 37371178, 37371180,
37371500, 37371500, 37371547, 37371548, 37372195, 37372585, 37372586, 37372589,
37372592, 37372736, 37372941, 37372942, 37372943, 37372946, 37373092, 37373294,
37377735, 37377816, 37380563, 37380589, 37380590, 37380611, 37380612, 37380613,
37380614, 37380615, 37380616, 37380617, 37380664, 37380680, 37380681, 37381174,
37381175, 37381682, 37381690, 37381692, 37381693, 37381696, 37381697, 37381701,
37381702, 37381703, 37381704, 37381707, 37381708, 37381711, 37381714, 37381719,
37381722, 37381724, 37381730, 37381734, 37385933, 37386729, 37386730, 37386731,
37386732, 37398412, 37404258, 37404270, 37410107, 37410669, 37410737, 37426060,
37441282, 37475899, 37475900, 37488841, 37488908, 37488910, 37494355, 37494355,
37494356, 37494356, 37494447, 37494454, 37494458, 37494461, 37494462, 37494680,
37494682, 37494685, 37494689, 37494733, 37494736, 37494738, 37494741, 37494744,
37494747, 37494763, 37494809, 37494890, 37494964, 37494966, 37495059, 37495123,
37495131, 37495441, 37495483, 37495484, 37495486, 37495487, 37495488, 37499017,
37499017, 37499200, 37499201, 37499202, 37499203, 37499204, 37499205, 37499224,
37499345, 37499351, 37499497, 37499557, 37499657, 37499659, 37499661, 37502162,
37502164, 37502167, 37502168, 37502169, 37502170, 37502171, 37502894, 37502897,
37502898, 37502901, 37503118, 37503121, 37503122, 37503124, 37503126, 37503127,
37503128, 37503129, 37503130, 37503131, 37503133, 37503196, 37503244, 37503245,
37503246, 37503247, 37503248, 37503423, 37503423, 37505870, 37506943, 37506944,
37506945, 37506946, 37506947, 37506948, 37506953, 37506975, 37513568, 37513569,
37513596, 37513666, 37513669, 37513671, 37513673, 37513675, 37513677, 37513680,
37513685, 37513686, 37513687, 37513689, 37513698, 37513701, 37518148, 37518174,
37518175, 37518180, 37518181, 37518186, 37518189, 37518189, 37518190, 37518190,
37518198, 37518228, 37518229, 37518316, 37521298, 37521299, 37521304, 37521305,
37521311, 37521328, 37521330, 37521331, 37521332, 37521333, 37521334, 37521335,
37521336, 37521337, 37521338, 37521339, 37521340, 37521341, 37521343, 37521344,
37521345, 37521346, 37524484, 37524489, 37524491, 37524531, 37524538, 37524557,
37524559, 37524560, 37524563, 37524569, 37524575, 37524581, 37524582, 37524583,
37524636, 37524639, 37525432, 37525433, 37525434, 37525435, 37525437, 37525438,
37525442, 37525870, 37534823, 37534968, 37534969, 37534970, 37535205, 37535206,
37536810, 37536816, 37536831, 37536832, 37536971, 37537170, 37537175, 37539183,
37539184, 37539185, 37539486, 37539487, 37539488, 37540470, 37540471, 37540558,
37540841, 37540842, 37542689, 37542990, 37542994, 37542995, 37542996, 37543000,
37543001, 37543005, 37543038, 37543062, 37543065, 37543067, 37543077, 37543080,
37543081, 37543082, 37543083, 37543084, 37543087, 37543088, 37543090, 37543091,
37543093, 37543100, 37543106, 37543108, 37543231, 37543563, 37543564, 37543565,
37546843, 37546844, 37546845, 37546846, 37546847, 37546850, 37546851, 37546853,
37546854, 37546855, 37546857, 37546858, 37546859, 37546862, 37553469, 37553474,
37553475, 37553476, 37553482, 37554331, 37563996, 37563997, 37563998, 37563999,
37564505, 37564506, 37564507, 37564969, 37564969, 37565641, 37569249, 37569256,
37569257, 37569258, 37569259, 37569260, 37569261, 37569265, 37569266, 37569327,
37569341, 37569391, 37569689, 37573492, 37573493, 37574329, 37574330, 37574331,
37574333, 37574334, 37574336, 37574340, 37574341, 37584475, 37585125, 37585128,
37586088, 37586089, 37589197, 37589397, 37592029, 37592042, 37592042, 37592043,
37592043, 37592092, 37592093, 37592094, 37593313, 37593313, 37593314, 37593314,
37593316, 37593316, 37593318, 37593318, 37593319, 37593319, 37595719, 37595720,
37595721, 37595722, 37596072, 37596073, 37596074, 37596076, 37596077, 37596093,
37596094, 37596099, 37596100, 37596104, 37596106, 37596111, 37596115, 37596119,
37596120, 37596962, 37604552, 37604553, 37604554, 37604569, 37604582, 37604583,
37604584, 37604585, 37604586, 37604640, 37604661, 37604698, 37604739, 37604758,
37604778, 37604779, 37604789, 37604816, 37604823, 37604827, 37604834, 37604851,
37604852, 37604857, 37604873, 37605119, 37605120, 37605133, 37605134, 37605140,
37605144, 37605145, 37605145, 37605153, 37605219, 37607894, 37607897, 37607917,
37607918, 37607919, 37607921, 37607922, 37607923, 37607924, 37607925, 37607926,
37607927, 37607928, 37607930, 37607931, 37607932, 37607933, 37607934, 37607935,
37607936, 37607938, 37607939, 37607940, 37607941, 37607942, 37607943, 37607945,
37607946, 37607947, 37607949, 37607950, 37607951, 37607952, 37607953, 37607954,
37607955, 37607956, 37607957, 37607958, 37607959, 37607960, 37607961, 37607962,
37607963, 37607964, 37607965, 37607966, 37607967, 37607968, 37607969, 37607970,
37608253, 37608276, 37608277, 37608278, 37609291, 37609294, 37609303, 37611851,
37611857, 37611858, 37611859, 37611863, 37611867, 37611870, 37611871, 37611872,
37611877, 37611881, 37611907, 37611908, 37611909, 37611910, 37611911, 37611912,
37611913, 37611914, 37611915, 37611916, 37611917, 37611918, 37611933, 37612135,
37612136, 37613013, 37613014, 37613014, 37613015, 37613015, 37613016, 37613016,
37613017, 37613017, 37613018, 37613018, 37613019, 37613019, 37613031, 37613032,
37613033, 37613034, 37613035, 37613036, 37613037, 37613038, 37613039, 37613040,
37613043, 37613048, 37613049, 37613050, 37613051, 37613052, 37613055, 37613072,
37613109, 37613515, 37613515, 37613516, 37613516, 37613517, 37613517, 37613518,
37613518, 37613519, 37613519, 37613520, 37613520, 37616722, 37616723, 37616724,
37616725, 37616726, 37616727, 37616728, 37616729, 37616730, 37616731, 37620258,
37620259, 37620260, 37620261, 37620262, 37620263, 37620264, 37620265, 37620266,
37620267, 37620268, 37620269, 37620270, 37620271, 37620272, 37620273, 37620274,
37620275, 37620276, 37620277, 37620278, 37620279, 37620280, 37620281, 37620282,
37620283, 37620284, 37620285, 37620286, 37620287, 37620288, 37624306, 37624310,
37624311, 37624312, 37624315, 37624318, 37624613, 37624979, 37624979, 37625061,
37625062, 37625124, 37625125, 37625126, 37625127, 37625145, 37625146, 37625147,
37625161, 37625163, 37625167, 37628407, 37628550, 37628551, 37628552, 37628553,
37628554, 37628555, 37628556, 37628557, 37628558, 37628559, 37628560, 37628561,
37628562, 37628563, 37628564, 37628565, 37628566, 37628567, 37628568, 37628569,
37628570, 37628571, 37628572, 37628573, 37628574, 37628575, 37628576, 37628577,
37628578, 37628579, 37628580, 37628581, 37628582, 37628583, 37628584, 37628585,
37628586, 37628587, 37628588, 37628589, 37628590, 37628591, 37628592, 37628593,
37628594, 37628595, 37628596, 37628597, 37628598, 37628599, 37628600, 37628601,
37628602, 37628603, 37628604, 37628605, 37628606, 37628607, 37628608, 37628609,
37628610, 37628611, 37628612, 37628613, 37632499, 37632500, 37632501, 37632502,
37632503, 37632504, 37632918, 37632922, 37632941, 37632945, 37632946, 37632947,
37632948, 37632951, 37632952, 37632953, 37632955, 37632956, 37632958, 37632959,
37632960, 37632961, 37632963, 37632964, 37632967, 37633634, 37633636, 37636570,
37636571, 37636572, 37636573, 37636574, 37636575, 37636576, 37636577, 37636578,
37636579, 37636659, 37652880, 37652883, 37652883, 37660898, 37660902, and
37661630
RECALLING
FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA,
REASON Affected devices contain a Biphasic PCBA that may have a
solder defect on the H Bridge component that could prevent the device from
providing a defibrillation shock. There could be a delay in therapy or
prevention of defibrillation therapy if the defibrillator were needed in a
cardiac arrest situation. Delay or prevention of defibrillation therapy may
contribute to the death of a viable patient.
VOLUME OF PRODUCT IN COMMERCE 1,718 units
DISTRIBUTION Nationwide, Australia, Brazil, Canada, Colombia,
Costa Rica, Germany, Hong Kong, Mexico, Netherlands
PRODUCT
CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC,
a Johnson & Johnson Company. CODE Lot number 0019, Exp
1/8/2010; 0019B, Exp 1/8/2010; 0039, Exp 3/16/2010; 0059, Exp 3/6/2010, 0079,
Exp 2/20/2010; 0099, Exp 6/24/2010.
RECALLING FIRM/MANUFACTURER
Veridex, LLC, Raritan, NJ,
REASON Veridex has received 4 complaints regarding reagent
bottles having been incorrectly placed or duplicate bottles places within the
reagent tray of CellSearch Circulating Tumor Cell Kit.
VOLUME OF PRODUCT IN COMMERCE 1641 kits in US, 380
internationally
DISTRIBUTION Nationwide, Belgium, France, Germany, Italy,
Spain, United Kingdom, Netherlands, Norway and Israel
PRODUCT
Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size
6, Left.
CODE Lot 53944312
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp,
REASON
Partial lot of product was not manufactured to specification. Central locking
screw was missing threads. There is a potential for dissociation because the
screw is not able to be used as a secondary fixation method.
VOLUME OF PRODUCT IN COMMERCE 17 units
DISTRIBUTION TX, FL, GA, CA, AZ, Japan
PRODUCT
1) RambaChrom KPC M/N 11500. 2) RambaChrom VRE M/N 11600. CODE
1) Lot # 8273017 Exp. Date 11/18/2008; Lot# 8357002 Exp. Date 2/9/2009; Lot#
9099062 Exp. Date 5/28/2009; Lot# 9121097 Exp. Date 6/19/2009; Lot# 9132038 Exp.
Date 6/30/2009; Lot# 9134085 Exp. Date 7/2/2009; Lot# 9139025 Exp. Date
7/7/2009; Lot# 9166026 Exp. Date 8/3/2009; Lot# 9177131 Exp. Date 8/14/2009;
Lot# 9194004 Exp. Date 8/31/2009; Lot# 9212080 Exp. Date 9/18/2009; Lot# 9222002
Exp. Date 9/28/2009; Lot# 9232053 Exp. Date 10/8/2009; Lot# 9275097 Exp. Date
11/20/2009; Lot# 9288050 Exp. Date 12/3/2009; Lot# 9306001 Exp. Date 12/21/2009;
Lot# 9322047 Exp. Date 1/6/2010;
2) Lot # 8256101 Exp. Date 11/21/2008; Lot # 8260028 Exp. Date 11/25/2008; Lot #
8289053 Exp. Date 12/24/2008; Lot # 8291088 Exp. Date 12/26/2008; Lot # 8308002
Exp. Date 1/12/2009; Lot # 8344022 Exp. Date 2/17/2009; Lot # 9015084 Exp. Date
3/26/2009; Lot # 9034041 Exp. Date 3/24/2009; Lot # 9043079 Exp. Date 4/23/2009;
Lot # 9072081 Exp. Date 5/22/2009; Lot # 9077047 Exp. Date 5/27/2009; Lot #
9100101 Exp. Date 6/19/2009; Lot # 9128102 Exp. Date 7/17/2009; Lot # 9159001
Exp. Date 8/17/2009; Lot # 9170108 Exp. Date 8/28/2009; Lot # 9175051 Exp. Date
9/2/2009; Lot # 9196042 Exp. Date 9/23/2009; Lot # 9210041 Exp. Date 10/7/2009;
Lot # 9215002 Exp. Date 10/12/2009; Lot # 9224046 Exp. Date 10/31/2009; Lot #
9240088 Exp. Date 11/6/2009; Lot # 9264003 Exp. Date 11/30/2009; Lot # 9287031
Exp. Date 12/23/2009; Lot # 9296067 Exp. Date 1/2/2010; Lot # 9315031 Exp. Date
1/20/2010; Lot # 9321020 Exp. Date 1/26/2010
RECALLING FIRM/MANUFACTURER
Gibson Laboratories Inc., Lexington KY,
REASON Discrepancies between the product package label and
technical insert are conflicting and may be misleading to user. The technical
insert included the statement for In Vitro Diagnostic Use. The product insert
should have indicated for Research Use Only instead of for In Vitro Diagnostic
Use.
VOLUME OF PRODUCT IN COMMERCE
1) 15330 units; 2) 3440 units
DISTRIBUTION Nationwide and France
PRODUCT
1) Cybernet Medical MedStar Telemedicine System; Model 533-210. The device is
for a remote medical data collection device for the monitoring of patients by
healthcare providers. It is intended to work with a weight scale, spirometer,
blood pressure unit and pulse oximeter and to transmit data over a phone line.
2) Cybernet Medical MedStar Telemedicine System; Model 533-380. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
3) Cybernet Medical MedStar Telemedicine System; Model 533-386. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
4) Cybernet Medical MedStar
Telemedicine System; Model 533-381. The device is for a remote medical data
collection device for the monitoring of patients by healthcare providers. It is
intended to work with a weight scale, spirometer, blood pressure unit and pulse
oximeter and to transmit data over a phone line.
CODE
1) Serial number range affected was 2778 through 4085. Serial numbers 2826,
3719, 3726, 4045 and 4048 have not yet been corrected;
2) Serial number range affected is 3554 through 3798. Serial numbers 3554, 3559, 5375, 3579, 3584, 3586, 3587, 3594, 3615, 3655, 3664, 3669 ,3670, 3676, 3680, 3682, 3683, 3694, 3696, 3703, 3708, 3725, 3744 and 3798 have not yet been corrected.
3) Serial numbers 3812, 3814 and 3824 have not yet been corrected. No others were in need of correction.
4)
Serial number 3657. This unit has been corrected
RECALLING FIRM/MANUFACTURER
Cybernet Systems Corp., Ann Arbor, MI,
REASON
A software problem renders these devices incapable of capturing lung function,
oxygen saturation and pulse data collected from multiple tests in accordance
with the instructions for use.
VOLUME OF PRODUCT IN COMMERCE 88 units
DISTRIBUTION CA, FL, GA, IL, LA, MI, MS, NY, OK, WV
PRODUCT
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight;
Product Code: M002004910580. CODE Lot # 12633379, Exp: 4/2012
RECALLING FIRM/MANUFACTURER
Maquet Cardiovascular, LLC, Wayne, NJ,
REASON Labeling mix up: Shelf Carton label for Exxcel Soft Thin
Wall Vascular Grafts, were mislabeled as Exxcel Soft Standard Wall Grafts.
Bleeding could occur if wrong product is used.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION TX, TN, CT, AR, AZ, Austria and France
PRODUCT Percutaneous
Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm,
catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize. For
catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman
technique.
CODE Lot 99715418, Exp 2014-05
RECALLING FIRM/MANUFACTURER
Argon Medical Devices, Inc., Athens, TX,
REASON One lot of Percutaneous Catheter Introducer Set
contained incorrect size needle.
VOLUME OF PRODUCT IN COMMERCE 500 units
DISTRIBUTION Nationwide
PRODUCT
1) IDEAL MAXPAC TOTAL SYSTEM (USA), Sterile and Nonpyrogenic, ETO or Gamma
Sterilized, Medtronic Perfusion Systems, Model: TS9453R29, TS9453R30, TS1470R1,
TS1442R1, TS9800R32, TS8299R4. ;
2) ONE SOURCE PACK, Model TK2S24,
EE2S048 (OUS).
CODE
1) Lot #: 1058285, 10059556, 1099512, 1106926, 1106983, 1001369;
2) Lot #: 1093645, 1102929, 1139554
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc., Minneapolis, MN,
Manufacturer: Medtronic Cardiovascular Revascularization & Surgical
Therap, Brooklyn Park, MN.
REASON Medtronic has identified a small number of
Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use
Before Dates (UBD) on the outer kit package label. The UBD on the outer label of
the kit/pack does not accurately reflect the UBD of the components within the
kit/Pack. For affected product, the outer label lists a date which may be later
than the USB of the components included in the kit/pack.
VOLUME OF PRODUCT IN COMMERCE 36 units
DISTRIBUTION CA, CO, Japan, China
PRODUCT ERIC
(Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in
conjunction with: remel RapID Yeast Plus System is a qualitative micromethod
employing conventional and chromogenic substrates for the identification of
medically important yeast, yeast-like, and related organisms isolated from human
clinical specimens. A complete listing of the organisms addressed by the RapID
Yeast Plus System is given in the RapID Yeast Plus Differential Chart. RapID"
YEAST PLUS System, Catalog No. R8311007. 4 hour identification of yeast based on
enzyme technology. Database includes over 40 taxa. Requires Inoculation Fluid,
REF R8325106. CE, 20 Panels/Kit.
CODE Lot No. 0001096277
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS
REASON There is an error in Version 1.0.77 of the electronic
code compendium (ERIC) software. The error is limited to the database
corresponding to the R8311007 RapID Yeast Plus System. The database erroneously
includes Candida dubliniensis as well as displays an incorrect temperature range
as an accessory test for codes with an overlap between Candida albicans and
Candida dubliniensis. When using the RapID Yeast Plus panel, selecting
"Display All Accessory Tests" indicated Growth at 37 o C for Candida
albicans vs "No Growth" for Candida dubliniensis. The appropriate
temperature range for resolving this overlap is 42-45 o C, at which C. albicans
should exhibit growth but C. dubliniensis should not. The Instructions for Use
for the RapID Yeast Plus System have recently been revised to address the
biochemical similarities between these two species and indicates the correct
methods to help distinguish between them. A software patch has been issued to
modify the RapID Yeast Plus Database file. The patch is downloadable and will
delete all data and references related to Candida dubiniensis from the database.
VOLUME OF PRODUCT IN COMMERCE 143 units
DISTRIBUTION Nationwide, Europe and Canada