JUNE 2002

WEEK ENDING JUNE 1

 

PRODUCT EBI XFIX DFS OptiROM Elbow Fixator. The product is sold non-sterile and is packaged either in an inner foam liner aluminum metal casing or in plastic bag.

CODE DC09575 or 09575 will be etched on the unit and the following lot numbers: 40994, 44782, 206883, 204881, 204882, 271159, 288313,

316281, 355170, 393638, 422625, 439685, 456129, 493368, 500176, 504015, 522720, 516609.

RECALLING FIRM/MANUFACTURER EBI, l.p., Parsippany, NJ

REASON Pin migration at the connection of OptiROM central body and fixator.

VOLUME OF PRODUCT IN COMMERCE 339.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Seprapack-Unilateral Application, sterile. (Bioresorbable nasal packing and sinus stent).

CODE Product Code: 7089-0807 Lot Number: 51579V.

RECALLING FIRM/MANUFACTURER Genzyme Biosurgery, a division of Genzyme Corp., Fall River, MA

REASON Product packaging may have voids in the seal compromising sterility of device.

VOLUME OF PRODUCT IN COMMERCE 348 units.

DISTRIBUTION TN.

 

PRODUCT Bayer Immuno 1(R) Troponin I Method. Common Name: Immuno 1(R) Troponin I Method.

CODE Product No. T01-3887-51, Lot V60275.

RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corp., Business Group Diagnostics, Tarrytown, NY

Manufacturer: Fisher Diagnostics Middletown, VA.

REASON Complaints received of low recoveries on Immuno 1 Troponin I Reagent Lot V60275.

VOLUME OF PRODUCT IN COMMERCE 6488 units.

DISTRIBUTION Nationwide and Puerto Rico.

 

PRODUCT Puritan Bennett-840 Ventilator System with optional compressor.

CODE Ventilators with Rev. E BD CPU boards with Serial numbers 3510000007 through 3510012304.

RECALLING FIRM/MANUFACTURER Recalling Firm: TYCO Healthcare, Nellcor Puritan Pennett, Pelasanton, CA

Manufacturer: Nellcor Puritan Bennett Ireland, ltd. Mervue, Galway, Ireland

REASON Failure of optional compressor on ventilator.

VOLUME OF PRODUCT IN COMMERCE 2,599 ventilators systems and 299 field replacement units with Rev. E BD CPU boards

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) Lightcycler microchemistry analyzer, catalog number 2011468, printers; b) Lightcycler microchemistry analyzer, catalog number 2043912, printers; c) Lumi Imager microchemistry analyzer, catalog number 2012847, printers.

CODE All Hewlett Packard Deskjet 800 and 900 series and PhotoSmart 1000, 1100, 1200 and 1300 series printers shipped between April 2001 and January 2002 with a Longwell "LS-7C" gray two-prong power cord.

RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN

Manufacturer: Hewlett Packard Company, Loveland, CO.

REASON Printer power cord poses a shock hazard.

VOLUME OF PRODUCT IN COMMERCE 220.

DISTRIBUTION Nationwide.

 

PRODUCT Linvatec brand Double-Armed, Straight, Trocar Point 13 (33cm) Suture Needle Polyester, Green Braided, 36 (91.4cm) 2-0 U.S.P 3.0. metric.

CODE , 32188, 430382, 432189, 432190, 434760, 456391, 465144, 469384, 466961, 473349, 80470, 486004.

RECALLING FIRM/MANUFACTURER ReGen Biologics, Inc., Redwood City, CA

REASON Sterility may be compromised.

VOLUME OF PRODUCT IN COMMERCE 10,760 units.

DISTRIBUTION Nationwide.

 

PRODUCT Synapse Image and Information Management System.

CODE Synapse Image and Information Management System with software versions 2.0.2 and 2.1.1.

RECALLING FIRM/MANUFACTURER Fujifilm Medical Systems U.S.A., Inc., Stamford, CT

REASON Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped.

VOLUME OF PRODUCT IN COMMERCE 70.

DISTRIBUTION Nationwide.

 

PRODUCT Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console.

CODE Serial Numbers: 0202-5000 to 0402-5126.

RECALLING FIRM/MANUFACTURER Recalling Firm: Mallinckrodt, Inc. / Liebel-Flarsheim Business, Cincinnati, OH

Manufacturer: Liebel-Flarsheim Co., Cincinnati, OH

REASON Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID.

VOLUME OF PRODUCT IN COMMERCE 62.

DISTRIBUTION Nationwide and Canada, Taiwan, China, So. Africa and Australia.

 

PRODUCT Stryker Secure II hospital beds with an optional 110V outlet box assembly.

CODE All beds manufactured between June 1, 2001 and February 19, 2002 that has the optional 110V outlet assembly box.

RECALLING FIRM/MANUFACTURER Stryker Corp., Kalamazoo, MI

REASON Shock hazard.

VOLUME OF PRODUCT IN COMMERCE 1,4460 beds.

DISTRIBUTION United States and Canada.

 

PRODUCT Duoflo, Applicator Dispenser Kit, with Tisseal VH, Fibrin Sealant.

CODE Product Code 921023; lot number 03130001 in USA.

Lot 05290106 in foreign distribution.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Baxter Healthcare Corporation Glendale, CA

Manufacturer: Hemaedics, Inc., Brentwood, CA

REASON Tip breakage into surgical site.

VOLUME OF PRODUCT IN COMMERCE 11,624.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) 3T vent valves for perfusion circuits sterile; b) 3T vent valves for perfusion circuits; non-sterile.

CODE a) CATALOG # 030 (STERILE)- all lots bearing a sterilization date prior to April 5, 2002.

b) CATALOG #030NS (NON-STERILE)- all lots sold to manufacturers prior to initiation of the recall.

RECALLING FIRM/MANUFACTURER Recalling Firm: 3T Medical Systems, LLC, Dearborn, MI

Manufacturer: MPC/Geneva Medical Products, Prairie Du Chien, WI

REASON Inadequate bond allows blood leakage or separation during use.

VOLUME OF PRODUCT IN COMMERCE 7,200.

DISTRIBUTION Nationwide.

 

PRODUCT EB-250S and EB-450S bronchoscope.

CODE Model/Catalog No. EB-250S: Serial Numbers: 2B027C002; 2B027C051, 2B027C061, 2B027C003, 2B027C067, 2B027C005, 2B027C001, 2B027C004, 2B027C017, 1B027C016, and 1B027C017 Model/Catalog No. EB-450S: Serial Numbers: 1B028C048, 1B028C011, 1B028B040, 1B028C004, 1B028C013, 2B028C007, 2B028C008, 2B028C070, 2B028C076, 2B028C023, 2B028C001, 2B028C013, 2B028C015, 2B028C048,

2B028C002, 2B028C009, 2B028C010, 2B028C003, 2B028C033, 2B028C017, and HB028A038.

RECALLING FIRM/MANUFACTURER Recalling Firm: Fujinon, Inc., Wayne, NJ

Manufacturer: Fuji Photo Optical Co. Ltd., Omiya, Saitama, 300-0036, Japan

REASON During brochoscopy, suction valve stuck in active position.

VOLUME OF PRODUCT IN COMMERCE 32.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT Padgett Instruments, Inc. roller cylinder for the Mesh Skin Graft Expander, Model P-170, for use in producing a honeycomb pattern on the graft so it will expand.

CODE Not coded.

RECALLING FIRM/MANUFACTURER Recalling Firm: Padgett Instruments, Inc., Kansas City, MO

Manufacturer: Dadson Mfg. Corp., Grain Valley, MO.

REASON The roller assembly might be defective.

VOLUME OF PRODUCT IN COMMERCE 39 P-170 units as of 4/24/02.

DISTRIBUTION FL, WV, NY and TX and Brazil, Portugal, Chile, Finland, England, Spain and Ireland.

 

WEEK ENDING JUNE 8

 

PRODUCT LTV Series Ventilators. Models: a) LTV 1000 (cat. no. 10130); b) Model LTV 950 (cat. no. 10950); c) Model LTV 900 (cat. no. 10638); d) Model LTV 800 (cat. no. 11800)

CODE Forthcoming.

RECALLING FIRM/MANUFACTURER Pulmonetic Systems, Inc., Colton, CA

REASON Shorts to inoperative condition.

VOLUME OF PRODUCT IN COMMERCE 1,890 finished devices and 82 turbine assemblies.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Ti Cann Troch Fixation Nail. ; Trochanteric Fixation Nail.

CODE Part number 456.318S, lot numbers 4333900 exp. 11/10, 4333901 exp. 12/10, and 4340289 exp. 12/10.

Part number 456.322S, lot numbers 4333904 exp. 11/10, 4340293 exp. 12/10, 4340295 exp. 12/10.

Part number 456.325S, lot number 4320398 exp. 12/10.

Part number 456.328S, lot number 4320395 exp. 12/10.

Part number 456.414S, lot number 4349527 exp. 12/10.

Part number 456.416S, lot numbers 4333921 exp. 11/10, 4333922 exp. 11/10, 4340324 exp. 12/10, and 4348124 exp. 12/10.

Part number 456.418S, lot number 4340328 exp. 12/10.

Part number 456.421S, lot number 4340334 exp. 12/10.

Part number 456.422S, lot number 4333929 exp. 11/10.

Part number 456.425S, lot number 4346091 exp. 12/10.

Part number 456.511S, lot number 4348136 exp. 12/10.

Part number 456.322S, lot number 4333903 exp. 12/10.

RECALLING FIRM/MANUFACTURER Recalling Firm: Synthes (USA), Paoli, PA

Manufacturer: Synthes (USA), Monument, CO.

REASON Hole not properly centered.

VOLUME OF PRODUCT IN COMMERCE 71 units.

DISTRIBUTION Nationwide and Switzerland.

 

PRODUCT Hill-Rom brand Horizon P100705 monitor slide

CODE All units built prior to May 2001.

RECALLING FIRM/MANUFACTURER Hill-Rom Co. Inc., Batesville, IN

REASON Monitor may fall.

VOLUME OF PRODUCT IN COMMERCE 381 units.

DISTRIBUTION Nationwide and Egypt.

 

PRODUCT a) Ballard Express Pre-Assembled Biliary Stent Systems.

b) Ballard Standard Biliary Stent Sets with and without guide wire.

c) Ballard Holland Biliary Stent Sets with and without guide wire.

d) Ballard Pancreatic Stent Sets with and without guide wire.

All sets are packaged in sterile 1-each package.

CODE a) Catalog Number: 63000 Lot numbers: 101296, 120483, 122702, 125804, 126787, 128723, 129804, 132833, 142812, 151458, 156020, 91425, 91426, 91427

Catalog Number: 63001 Lot Numbers: 101297, 102446, 103780, 107268, 110876,117880, 1125805, 128187, 128724, 130780, 133712, 137831, 139088,

156997, 160503, 165093.

Catalog Number: 63002 Lot Number: 101298, 102454, 103781, 109316, 116585, 120484, 121332, 122703, 127468, 128725, 128993, 137023, 139993,

144126, 146988, 148556, 150150, 152326, 157776, 165094, 99726.

Catalog Number: 63003 Lot Number: 101299, 102455, 107269, 119047, 120485, 121333, 122704, 126788, 128726, 129805, 131552, 135976, 144190, 158318.

Catalog Number: 63004 Lot Number: 101300, 120486, 121334, 125554, 125806, 128727, 128994, 132045, 135977.

Catalog Number: 63005 Lot Number: 101301, 1119749, 120487, 121335, 125555, 125807,128188, 128728, 130781, 133713, 134524, 135394, 140688,

142813, 144128, 144191, 165095.

Catalog Number: 63006 Lot Number: 101302, 125556, 128729, 128995, 129806, 132834, 135395, 135979, 139089, 142814, 143480, 148557.

Catalog Number: 63007 Lot Number: 101303, 125557, 139995, 142107, 143481, 144129,146989, 149414, 150151, 151459, 152327, 156022.

Catalog Number: 63008 Lot Number: 101304, 125559, 132504, 135396, 135980, 138023,140689, 142815, 144192, 153100, 156999, 158320, 160505, 165096.

Catalog Number: 63009 Lot Number: 121336, 125560, 128189, 132505, 135981, 139090,141320.

Catalog Number: 63130 Lot Number: 137415, 139095, 141325, 145264.

Catalog Number: 63131 Lot Number: 137416, 140000, 144743, 145265, 146110.

Catalog Number: 63132 Lot Number: 137417, 144744, 144972.

Catalog Number: 63133 Lot Number: 137418, 145267, 147015.

Catalog Number: 63134 Lot Number: 137419

b) Catalog Number: 63040 Lot Number: 101161, 125561, 138028.

Catalog Number: 63041 Lot Number: 101162, 125562, 146095.

Catalog Number: 63042 Lot Number: 101163, 125563.

Catalog Number: 63043 Lot Number: 101164, 125564.

Catalog Number: 63044 Lot Number: 101165, 125565, 150153.

Catalog Number: 63045 Lot Number: 101166

Catalog Number: 63046 Lot Number: 101167, 125567.

Catalog Number: 63047 Lot Number: 101168, 125568, 140691, 143483, 154735, 157309,160462, 160506.

Catalog Number: 63048 Lot Number: 101169, 119753, 125569, 128720, 129813, 132837,135397, 135982, 138029, 139091.

Catalog Number: 63049 Lot Number: 101170, 125570, 130782, 133714, 135398, 135983.

Catalog Number: 63050 Lot Number: 102456, 125571.

Catalog Number: 63051 Lot Number: 125572.

Catalog Number: 63052 Lot Number: 125573, 130783, 133715.

Catalog Number: 63053 Lot Number: 125574, 128722.

Catalog Number: 63054 Lot Number: 125575.

Catalog Number: 63055 Lot Number: 125576.

Catalog Number: 63056 Lot Number: 101183, 109317, 127855, 128767,129814, 138030.

Catalog Number: 63057 Lot Number: 125577.

Catalog Number: 63058 Lot Number: 125578.

Catalog Number: 63061 Lot Number: 112612, 125581.

Catalog Number: 63062 Lot Number: 101187, 125582, 142426.

Catalog Number: 63063 Lot Number: 101188, 125583, 141321.

Catalog Number: 63084 Lot Number: 101206, 125590.

Catalog Number: 63085 Lot Number: 102495, 125591.

Catalog Number: 63086 Lot Number: 101207, 125592.

Catalog Number: 63087 Lot Number: 101208, 125593.

Catalog Number: 63088 Lot Number: 125594.

Catalog Number: 63089 Lot Number: 101210, 125595, 128762, 130784, 133717.

Catalog Number: 63090 Lot Number: 103784, 125596, 131553, 134526, 135474, 137832, 138025, 144130, 145262, 149422.

Catalog Number: 63091 Lot Number: 101211, 125597, 131554, 131690, 134527, 137833,138026, 139996, 143489, 146102, 147000, 150157.

Catalog Number: 63092 Lot Number: 101212, 125598, 128763, 132838, 135984, 138027, 142110.

Catalog 63093 Lot Number: 101213, 125599.

Catalog Number: 63094 Lot Number: 101214, 125600.

Catalog Number: 63095 Lot Number: 102498, 125601.

Catalog Number: 63096 Lot Number: 125602

Catalog Number: 63097 Lot Number: 125603

Catalog Number: 63150 Lot Number: 103791

Catalog Number: 63165 Lot Number: 103792, 105512.

Catalog Number: 63166 Lot Number: 101049, 103893, 108831, 144139.

Catalog Number: 63167 Lot Number: 103794, 112611.

Catalog Number: 63168 Lot Number: 101050.

Catalog Number: 63169 Lot Number: 122712, 130786.

Catalog Number: 63171 Lot Number: 101053.

Catalog Number: 63172 Lot Number: 101054, 128766.

Catalog Number: 63173 Lot Number: 101055

Catalog Number: 63174 Lot Number: 101056.

c) Catalog Number: 63010 Lot Number: 91422, 91424.

Catalog Number: 63012 Lot Number: 101147, 119750.

Catalog Number: 63013 Lot Number: 105952, 120489.

Catalog Number: 63015 Lot Number: 119751.

Catalog Number: 63016 Lot Number: 101151, 128773, 132835.

Catalog Number: 63017 Lot Number: 101152, 128774, 132836, 155223, 156555.

Catalog Number: 63018 Lot Number: 101153, 129811, 146991, 157308.

Catalog Number: 63020 Lot Number: 105953, 120492.

Catalog Number: 63023 Lot Number: 101159

Catalog Number: 63070 Lot Number: 101193, 118685, 137027.

Catalog Number: 63071 Lot Number: 101194, 128770.

Catalog Number: 63072 Lot Number: 101195, 127469.

Catalog Number: 63073 Lot Number: 101196, 118686, 148560.

Catralog Number: 63074 Lot Number: 101197, 121305, 127470, 143485.

Catalog Number: 63075 Lot Number: 101198, 128772, 161901.

Catalog Number: 63076 Lot Number: 101199, 118687, 138024, 143486, 148957.

Catalog Number: 63077 Lot Number: 101200, 122706, 143487, 144871.

Catalog Number: 63078 Lot Number: 101201, 119754.

Catalog Number: 63079 Lot Number: 101202, 120496, 137028.

Catalog Number: 63080 Lot Number: 101203, 118688, 146101.

Catalog Number: 63081 Lot Number: 101204, 103782, 107270, 119755, 120497, 121306, 137029, 141322, 143488, 145261, 148561.

Catalog Number: 63082 Lot Number: 103783, 112062, 127856, 137030, 150939.

Catalog Number: 63083 Lot Number: 101205, 119756.

d) Catalog Number: 63175 Lot Number: 146116, 155441, 91410.

Catalog Number: 63176 Lot Number: 101057, 119763, 125618, 128918, 134531, 158321.

Catalog: 63177 Lot Number: 101058, 119764, 125619, 128194.

Catalog Number: 63178 Lot Number: 101059, 119765, 125620.

Catalog Number: 63179 Lot Number: 101060.

Catalog Number: 63181 Lot Number: 125623, 126790, 128783, 129821, 132056.

Catalog Number: 63182 Lot Number: 101063, 125624, 128195.

Catalog Number: 63183 Lot Number: 125625

Catalog Number: 63184 Lot Number: 101065, 125626.

Catalog Number: 63185 Lot Number: 101066, 91416, 91417, 91418.

Catalog Number: 63186 Lot Number: 101067, 105513, 126791, 128735, 132843.

Catalog Number: 63187 Lot Number: 101068, 107272, 125627, 132844.

Catalog Number: 63188 Lot Number: 101069, 125628, 132845.

Catalog Number: 63189 Lot Number: 101070, 125629, 128196, 132846.

Catalog Number: 63190 Lot Number: 101071, 125630, 127859, 130789, 132847.

Catalog Number: 63191 Lot Number: 101072, 105514, 126793, 130790, 132848.

Catalog Number: 63192 Lot Number: 101073, 109325, 111068, 132058.

Catalog Number: 63193 Lot Number: 101074, 119766, 125631, 132849, 135994, 140003.

Catalog Number: 63194 Lot Number: 101075, 125632, 130791, 132850.

RECALLING FIRM/MANUFACTURER Recalling Firm: Ballard Medical Products Draper, UT

Manufacturer: Ballard Medical Products, Pocatello, ID.

REASON Stent anchor wings may not project, thereby failing to anchor stent.

VOLUME OF PRODUCT IN COMMERCE 6,312 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Portex Tracheostomy Tube, Laryngectomy tube, and Nasopharyngeal Airway products as follows:

Flex D.I.C.(TM) Trach Tubes, Product Number, 504070,504080, 504090, 505070, 505080, 505090, 505100.

D.I.C.(TM) Trach Tubes, Product Number 502060, 502080, 502090, 503060, 503070, 503080, 503090, 503100, 512060, 512080, 512090, 513070, 513080.

Laryngectomy Tube Product Number, 562090.

Nasopharyngeal Airway Product Number, 340060, 340070, 340080, 340090.

Pediatric Trach Tubes Product Number, 555030, 555035, 555040, 555050, 555055.

Per Fit (R) Percutaneous Trach Tubes Product Number, 522070, 522080, 522090.

Lo Profile Trach Tube Product Number, 592070.

Blue Line(R) Trach Tubes Product Number, 508070, 518070, 518090, 521070, 521080, 521090, 530060, 530070, 530080, 530090, 531080, 531100, 550060, 550070, 550080, 550090.

CODE Portex Tracheostomy Tube, Laryngectomy Tube, and Nasopharyngeal Airway Products with the Lot Numbers listed below:

Flex D.I.C.(TM) Trach Tubes

Product Number Lot Number

504070 K108407

504080 110562, K108408

504090 108359, K108409

505070 109606, 110184, 110625,K101267, K101268, K112021

505080 108657

505090 108679, 110219, K101160, K112025

505100 108728, K105823

D.I.C.(TM) Trach Tubes

Product Number Lot Number

502060 109233

502080 K109382

502090 108614, K111020

503060 111010, 111072, K107619, K109385

503070 110075, 111482

503080 109057, 110632, 111069, 111070, K103444,

K107019, K107021, K107620, K112685, K112686

503090 108356, 108466

503100 K112023

512060 K105824, K109398, K112345

512080 K107023

512090 108616

513060 K106753

513070 111484, 111485

513080 K102747, K112026

Laryngectomy Tube

Product Number Lot Number

562090 108468

Nasopharyngeal Airway

Product Number Lot Number

340060 111187

340070 111073, K100232, K108108

340080 111582

340090 111388, K109963

Pediatric Trach Tubes

Product Number Lot Number

555030 K103059

555035 K107624

555040 111488, K102749

555050 K108417

555055 K106090

Per Fit (R) Percutaneous Trach Tubes

Product Number Lot Number

522070 108683, 111337

522080 111096

522090 111097, 111120, 111577

Lo Profile Trach Tube

Product Number Lot Number

592070 K101755

Blue Line(R) Trach Tubes

Product Number Lot Number

508070 109132

518070 108127, 109134

518090 109135, K108443

521070 111006

521080 110626, K112122

521090 110633, K108444

530060 110628, K105829

530070 110113, 111270

530080 109511, K101751, K101752, K101753, K112125

530090 K108445

531080 K105831

531100 108681

550060 K103057

550070 K105832

550080 K103058

550090 K108415.

RECALLING FIRM/MANUFACTURER Recalling Firm: Sims Portex, Inc., Keene, NH

Manufacturer: Portex, Inc., Keene, NH.

REASON Product package may have defective seals and compromise sterility of device.

VOLUME OF PRODUCT IN COMMERCE 22,794 units.

DISTRIBUTION Nationwide and Bahamas, Canada, Puerto Rico, Mexico and the United Kingdom.

 

PRODUCT AXIS/IRIX Gamma Camera System. A Prism XPVT System, Tomography, Computed, Emission, 90KPS System.

System Catalog # Gantry S/N affected

AXIS 210714 094-193

AXIS 210880 101-291

AXIS 211037 181-613

AXIS 211039 140-613

IRIX 210857 096-177,435

IRIX 210881 102-167

IRIX 211038 190-613

IRIX 211040 096-613.

CODE Serial Numbers: 094 through 613.

RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems, fka: Picker International, Inc., Highland Heights, OH

REASON If the patient table is lowered onto a nearby object, such as a gurney, it may cause it to tip over.

VOLUME OF PRODUCT IN COMMERCE 500.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT INRAD brand Express core biopsy device, single use, disposable, sterile; 18 gauge x 15 cm. Catalog # 901518.

CODE Lot 6020-1003, exp. 1/2005.

RECALLING FIRM/MANUFACTURER Recalling Firm: INRAD, Inc., Kentwood, MI

Manufacturer: Arlanda Medicinska Instrument Co. AB, Sollentuna,

REASON Extended expiration date on outer carton.

VOLUME OF PRODUCT IN COMMERCE 105.

DISTRIBUTION CA, SC, PA, TN and WA.

 

WEEK ENDING JUNE 15

 

PRODUCT Hematocrit and creatinine tests, as part of the i-STAT in-vitro diagnostic test system. Field Correction affected cartridges:

i-STAT 6+, E3+, EC4+, EC6+, EC8+.Recall cartridges: Crea.

CODE

Lot Cartridge Number Total

CREA R01331 9150

CREA R01318 7800

CREA R01327 7450

CREA R01305 5725

CREA R01349B 4500

CREA R01349 2575

CREA R01310 1750

CREA R01349A 1700

CREA R01355 1475

CREA R01310A 1075.

RECALLING FIRM/MANUFACTURER I-Stat Corp., East Windsor, NJ

REASON Erroneously high hematocrit results generated with cartridges.

VOLUME OF PRODUCT IN COMMERCE 43,200 crea cartridges.

DISTRIBUTION Nationwide.

 

PRODUCT Clearview HCG II Pregnancy Test

CODE Lot No. 4357, exp. 8/14/2002 4359, exp. 8/11/2002.

RECALLING FIRM/MANUFACTURER Recalling Firm: Medpointe, Inc. (Wampole Laboratories Division), Cranbury, NJ

Manufacturer: Unipath Ltd., Bedford, the United Kingdom.

REASON Sensitivity deterioration of pouched PRODUCT.

VOLUME OF PRODUCT IN COMMERCE Lot 4357 -- 448 kits; Lot 4359 -- 1,672 kits.

DISTRIBUTION Nationwide.

 

PRODUCT Mitek Clearfix Meniscal Screw, 2 mm x 10 mm.

CODE Catalog Number: 253101 Lot Numbers: 011097, 0111229, 0111337, 0112145, 0112291.

RECALLING FIRM/MANUFACTURER Mitek products, Norwood, MA

REASON Meniscal screw may be out of specification and not deploy properly.

VOLUME OF PRODUCT IN COMMERCE 698.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Brand name: Uropump Tube, Uropump Damping Chamber.The tube and chamber are sold stand-alone and in four kits, the Uropump Starter Kit, the Cavernosometry Starter Kit, and two different configurations of the Instrument Set Up Kit. When sold stand alone, the UPT is sold in a box of 50, and the UPDCC in a box of 25.

CODE UPDCC Lot numbers: 2835603 through 2836509; 2900101 through 2936509; 2A00101 through 2A36509; 2B00101 through 2B36103.

UPT Lot numbers: 2A27002 through 2A36502; 2B00101 through 2B34401.

RECALLING FIRM/MANUFACTURER Life-Tech Intl., Inc., Stafford, TX

REASON Device may not be sterile.

VOLUME OF PRODUCT IN COMMERCE 11,500 boxes.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Hill-Rom brand Affinity Three birthing bed.

CODE All models distributed prior to March 1, 2002.

RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN

REASON Bed may change position on its own.

VOLUME OF PRODUCT IN COMMERCE 1,927.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT HEARTPORT Brand Arterial Cannulas described as follows:

Endo Return, 21 Fr.

Endo Return, 23 Fr.

Direct Flow, 24 Fr.

StraightShot, Angled, 23 Fr.

Arterial, 19 Fr.

The above products are distributed separately as well as in the following Kit Model Numbers:

EAVR23A1

ECPB212

ECPB233

ECPBA214

ED241

EAVR-23-A

EAVR-23-S

ED-KIT

EAVR23A2

ECPB213

ECPB234

ECPBA231

ED242

SS-23-A

SS-23-S

SC-24

EAVR23S1

ECPB214

ECPBA211

ECPBA232

ED243

ECPB-AR21

ECPB-AR23

ED-24

EAVR23S2

ECPB231

ECPBA212

ECPBA233

ED244

ECPB-A21

ECPB-A23

ECPB211

ECPB232

ECPBA213

ECPBA234

SC24

ECPB-KIT

ECPB-AR-19.

CODE

ER21 (07043) for Endo Return, 21 Fr.

ER23 (07044) for Endo Return, 23 Fr.

DFK24 (06723) for Direct Flow, 24 Fr.

SS23A (06725) for StraightShot, Angled, 23 Fr.

AC19 (04000) for Arterial, 19 Fr.

SCK (06724) for Soft Clamp, 24 Fr.

SS23S (06726) for StraightShot, Straight, 23 Fr.

RECALLING FIRM/MANUFACTURER Heartport, Inc., Redwood City, CA

REASON A lap joint in certain arterial cannulas can separate.

VOLUME OF PRODUCT IN COMMERCE 1,800 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) Monotube Triax Carbon Tube 15x200mm, Yellow, used for the stabilization of open and/or unstable fractures.

b) Monotube Triax Carbon Tube 15x150mm, Yellow.

CODE a) Catalog No. 5150-2-381, Lot J326229; b) Catalog No. 5150-2-371, Lot J326228.

RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics, Corp., Rutherford, NJ

Manufacturer: Stryker Trauma SA, Geneva, Switzerland.

REASON 200mm monotube length package actually contains a 150mm length monotube.

VOLUME OF PRODUCT IN COMMERCE a) 4 ea; b) 2 ea.

DISTRIBUTION NJ.

 

PRODUCT VITROS Immunodiagnostics.Free T3 Reagent Packs

For in vitro diagnostic use. 100 test units per pack.

CAT 131 5589 Responsible firm on the label: Ortho-Clinical Diagnostics, Amersham, the United Kingdom.

CODE Lot numbers:

1) 500, Exp. 10 April 2002

2) 511, Exp. 22 May 2002

3) 512, Exp. 9 August 2002.

RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY

Manufacturer: Ortho-Clinical Diagnostics, Inc., Cardiff, Wales, the United Kingdom.

REASON Failure to include Supplemental Info. Sheet that contains updated values for Free Thyroid Control lots 60, 70 & 80.

VOLUME OF PRODUCT IN COMMERCE 262 domestic; and 1,981 international.

DISTRIBUTION Nationwide.

 

WEEK ENDING JUNE 22

 

PRODUCT STERRAD 100S Sterilization System

CODE Version 3 or lower is subject to upgrade. Newer versions contain software "fix". Current version is Version 6.

RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA

REASON Software anomaly allows half cycle run when full cycle displayed.

VOLUME OF PRODUCT IN COMMERCE 1,405

DISTRIBUTION Nationwide.

 

PRODUCT Interplak power plaque remover toothbrush, battery operated toothbrush used to brush teeth and remove plaque.

CODE Model number 12209W.

RECALLING FIRM/MANUFACTURER Recalling Firm: Conair Corp., East Windsor, NJ

Manufacturer: Gimelli Laboratories Co. Ltd., Shenzen Bao'An, Guangdong.

REASON Batteries leaking hydrogen gas during charging popping off the end cap.

VOLUME OF PRODUCT IN COMMERCE 15,758 units.

DISTRIBUTION Nationwide.

 

PRODUCT Invacare IRC 2121 Select Flow, CGS 870, 0-6L medical oxygen regulators.

CODE Serial numbers 0203 00322 through 0203 00496.

RECALLING FIRM/MANUFACTURER Essex Industries, Inc., St. Louis, MO

REASON Mislabeled as 0-6 LPM rather than 0-8 LPM.

VOLUME OF PRODUCT IN COMMERCE 175 regulators.

DISTRIBUTION IN.

 

FDA SUSPENDS OPERATIONS OF MEDICAL GAS FACILITY

 

The FDA has shut down certain operations of Air Liquide America Corp. (ALAC), a medical gas facility in Coatesville, Penna. The company had failed to assure that its industrial-grade trailers (also used for storing and hauling medical gases) are clean, purged, and completely free of contaminants prior to having them filled with medical gas, thereby creating a potential hazard for patients who use the product.

 

ALAC had agreed to comply with FDA product safety regulations called Current Good Manufacturing Practices (CGMP) in a consent decree (a court-sanctioned agreement between two parties) signed in November, 1997, but an FDA inspection on April 2, 3, and 10, 2002, found that the Coatesville facility had failed to meet the agreed upon standards. As a result, the inspected plant must immediately stop having their trailers filled with medical gas and must stop distributing medical gases.

 

Of greatest concern is that the use of trailers that have not been determined to be free of industrial gas could result in a contaminated medical gas. The consequences of inhaling contaminated medical gas may include aspiration pneumonia. ALAC must also determine whether any other facilities of the company are in violation of CGMPs, provide the FDA with a list of such facilities, and provide to FDA a certification that the violative practices have ceased.

 

ALAC may resume having its trailers filled with medical gas and distributing it to its medical customers once it has an expert consultant certify to FDA that its operations are in compliance with CGMP.

 

WEEK ENDING JUNE 29

 

PRODUCT NEMIO, SSA550A, Diagnostic Ultrasound System

CODE Serial Numbers: B1552349, C1572413, C1572414, C1572415, C1572417, C1572418, C1572420, C1572423, C1572428, C1572429, C1572430

C1572431, C1572432, C1572433, C1572421.

RECALLING FIRM/MANUFACTURER Toshiba America Medical Systems, Inc., Tustin, CA

REASON Software anomally caused error in calculating VM_P.

VOLUME OF PRODUCT IN COMMERCE 15.

DISTRIBUTION CA, ID, LA, MA, MD, MS, MT, OR and TX.

 

PRODUCT Puritan Bennett-840 Ventilator System with optional compressor

CODE Ventilators with Rev. E BD CPU boards with Serial numbers 3510000007 through 3510012304.

RECALLING FIRM/MANUFACTURER Recalling Firm: Tyco Healthcare, Nellcor Puritan Bennett, Pelasanton, CA

Manufacturer: Nellcor Puritan Bennett, Ireland, Ltd. Mervue, Galway, Ireland.

REASON Failure of optional compressor on ventilator.

VOLUME OF PRODUCT IN COMMERCE 2,599 ventilators systems and 299 field replacement units with Rev. E BD CPU boards.

DISTRIBUTION Nationwide and Internationally.