AUGUST 2002

WEEK ENDING AUGUST 3

 

PRODUCT CryoValve Allograft - Heart valve.

CODE Serial No. 6773739, Model No. PV00.

RECALLING FIRM/MANUFACTURER Cryolife, Inc. Kennesaw, GA

REASON Aortic valve donor was associated with alleged case of Endocarditis.

VOLUME OF PRODUCT IN COMMERCE One valve.

DISTRIBUTION CA.

 

PRODUCT LTV Series Ventilators

CODE LTV 1000, LTV 950 and LTV 800 Series Ventilator Serial numbers affected are:

A03816-A03840

C03168-C03197

D01006-D01010, D01013, D01015, D01021, D01022.

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

REASON EMI shield short circuits units, potential for fire.

VOLUME OF PRODUCT IN COMMERCE 64.

DISTRIBUTION PA, OH, FL, NC, GA, PA, WA, CA and to Canada, Japan, and Taiwan.

 

PRODUCT Ct Tri Pak Sterile disposable syringe kits.

CODE Catalog number CTP-200-FLS. Lot numbers 29764, 29765, and 29766.

RECALLING FIRM/MANUFACTURER Medrad, Inc., Indianola, PA

REASON May exceed endotoxin specification limits

VOLUME OF PRODUCT IN COMMERCE 41650 kits

DISTRIBUTION Nationwide and Sultanate of Oman, Korea, Taiwan and BR.

 

PRODUCT Intera 1.0T and 1.5T MR Systems Magnetic Resonance Systems are indicated for use as diagnostic devices that display the internal structure and/or function of the head, body or extremeties. The coils are used to obtain optimal imaging.

CODE Software version R7.1.2 and higher

RECALLING FIRM/MANUFACTURER Recalling Firm:  Philips Medical Systems North America, Inc., Bothell, WA

Manufacturer:  Philips Medical Systems Nederland B.V. Netherlands

REASON Higher than expected current in the insulation of the coil cable.

VOLUME OF PRODUCT IN COMMERCE 3.

DISTRIBUTION FL and WA.

 

PRODUCT STAAR Surgical UV Absorbing Posterior Chamber Intraocular Lens, Model - AQ5010V

CODE Serial Numbers: 3033515, 3040022, 3040026, 3523618, 3523692, 3033498, 3033542, 3040615, 3040616, 3033529, 3523628, 3178667, 3033540,

3431112, 3431109, 3040666, 3050410, 3178655, 3431093, 3037418, 3040623, 3432070, 3034695, 3432088, 3174470, 3044717, 3413510, 3431119,

3040647, 3044721, 3151535, 3151546, 3174464, 3040621, 3408081, 3033508, 3151441, 3151513, 3040646, 3040655, 3033570, 3033571, 3037477,

3040031, 3151439, 3040037, 3040046, 3040067, 3037476, 3432064, 3033555, 3033556, 3413514, 3178643, 3178644, 3050437, 3040614, 3037434,

3033520, 3040638, 3431111, 3523208, 3040051, 3040033, 3040049, 3432083, 3151437, 3431095, 3431116, 3040054, 3431108, 3037485, 3033573,

3432075, 3033561, 3037456, 3037457, 3033568, 3033569, 3050440, 3151536, 3037435, 3037442, 3033538, 3151438, 3432069, 3523186, 3040613,

3033521, 3523187, 3523188, 3523701, 3040060, 3037464, 3037465, 3174458, 3431106, 3523207, 3523197, 3037492, 3432067, 3034699, 3151443,

3033541, 3033550, 3040610, 3040624, 3040637, 3174453, 3523604, 3523210, 3033511, 3432066, 3040038, 3432598, 3523679, 3033576, 3033577,

3151528, 3178647, 3523195, 3040612, 3033500, 3033501, 3040035, 3408082, 3523695, 3033516, 3431094, 3432618, 3523696, 3034704, 3040620,

3033533, 3033539, 3523213, 3432089, 3432065, 3432597, 3523621, 3040651, 3040660, 3033527, 3431113, 3040639, 3040640, 3432609, 3432610,

3408087, 3432074, 3037470, 3040619, 3040635, 3040063, 3432603, 3040052.

RECALLING FIRM/MANUFACTURER Staar Surgical Co. Monrovia, CA

REASON Mislabeled as to diopter.

VOLUME OF PRODUCT IN COMMERCE 156.

DISTRIBUTION Nationwide and Puerto Rico and the Dominican Republic.

 

PRODUCT Ela/Angeion Lyra Model 2020, 2021, and 2022 Implantable Cardioverter Defibrillators. 

CODE All of the defibrillators are involved, and all of these units have been implanted.  The devices are no longer in distribution. The last implant occurred on August 18, 2000. 

RECALLING FIRM/MANUFACTURER Recalling Firm:  Angeion Corporation, St. Paul, MN.

Manufacturer:  Ela-Angeion, Plymouth, MN

REASON The devices could stop providing therapy due to premature battery depletion.

VOLUME OF PRODUCT IN COMMERCE 494.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Dyonics Direct View and Video Arthroscopes 4.0 mm as follows:

a) Part Number: 3622R, Video Arthroscope, 4mm x 30 degree, Repair;

b) Part Number: 3622S, Video Arthroscope, 4mm x 30 degree, Service;

c) Part Number: 3626R, Arthroscope, 4mm x 30 degree, Repair;

d) Part Number: 3626S, Arthroscope, 4mm x 30 degree, Service. Replacement;

e) Part Number: 4125S, Arthroscope, 4mm x 30 degree, Service Replacement

CODE a) Serial Number: HD208005                  

b) Serial Numbers: HD207995, HD208006, HD208009, HD208740, HD207981            

c) Serial Number: HD208802                              

d) Serial Numbers: HD207980, HD207984, HD207997, HD208008, HD208721, HD208731, HD208790, HD208760, HD208761,HD208762, HD208771, HD208780, HD208772, HD208779, HD208788, HD208789, HD209557, HD209559, HD209576, HD209589, HD209603                                   HD207988 HD208751                          

e) Serial Numbers: HD207986, HD208749, HD209577

RECALLING FIRM/MANUFACTURER Smith & Nephew, Inc. Andover, MA

REASON Arthroscopes may be missing weld and contamination may penetrate resulting in inadequate sterilization.

VOLUME OF PRODUCT IN COMMERCE 33.

DISTRIBUTION Nationwide and Australia, Mexico and the United Kingdom.

 

PRODUCT Stryker brand TPS U2 drill for use with the Stryker Total Performance System.

CODE Model 5100-100-000 drills built or repaired, and model 5100-100-900 drills with motor repairs made, from 3/7/02 to 3/26/02.

RECALLING FIRM/MANUFACTURER Stryker Corporation, Stryker Instruments Division, Kalamazoo, MI

REASON Possible shock hazard.

VOLUME OF PRODUCT IN COMMERCE 84 drills.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Surgeons Vest

CODE Lot Numbers 1020250, 1020320, 1020370, 1020380, 1020530.

RECALLING FIRM/MANUFACTURER Precept Medical Products, Inc. Arden, NC

REASON Incomplete seal on packaging.

VOLUME OF PRODUCT IN COMMERCE 187 cases/30 per case or 5,610 units.

DISTRIBUTION Nationwide.

 

PRODUCT SONOLINE Antares, Diagnostic Ultrasound System.  The SONOLINE Antares is a high-resolution, digital, broadband diagnostic ultrasound imaging system.  It supports the following diagnostic applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and urology.

CODE Units with software version 1.0 or 1.1.

RECALLING FIRM/MANUFACTURER Semens Medical Systems, Inc., Issaquah, WA

REASON Software anomalies that affect measurement and calculation data.

VOLUME OF PRODUCT IN COMMERCE 260 units.

DISTRIBUTION Nationwide.

 

PRODUCT Kimberly-Clark Multifunction Electrodes, R2 Pads, Self-adhesive Pre-gelled low impedance electrodes. Manufactured by Ballard Medical Products

CODE Catalog No. 3200-1715. Lot Numbers: 144766, 145094, 146041, 146042, 146636, 147350, 147352, 149095, 149096, 149885, 149886, 149887, 150667, 150668, 150669, 151605, 151987, 151988, 152848, 153541, 153592, 153671, 153878, 155327, 155928, 155929, 156742, 156743, 157681, 157682, 158661, 159261, 160052, 160053, 160061, 160062, 161079, 161080

RECALLING FIRM/MANUFACTURER Ballard Medical Products, Draper, UTREASON Unit label incorrectly identifies the pads as radiolucent.

VOLUME OF PRODUCT IN COMMERCE 88,518 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT ISPAN, Sulfur Hexafluoride (SF6) and Perfluoropane (C3F8) Liquified Gas under Pressure, for intraocular use.

Cylinder series LD2, LD1, and LD.

CODE Device Catalog Number 8065-7971-01 Alcon Customer Lot Information:

Transfill Lot #       Quantity Released                                              Size

021519                                    41                                                            LD2

021605                                    42                                                            LD2

021606                                    42                                                            LD1

021812                                    42                                                            LD2

022002                                    42                                                            LD2

022119                                    7                                                              LD2

022310                                    42                                                            LD1

022403                                    34                                                            LD1

023401                                    30                                                            LD

023518                                    42                                                            LD2

023519                                    42                                                            LD2

023520                                    42                                                            LD2

023521                                    41                                                            LD2

024403                                    40                                                            LD2

024404                                    23                                                            LD

024505                                    42                                                            LD2

024515                                    42                                                            LD2

024917                                    38                                                            LD2

024918                                    42                                                            LD2

025006                                    28                                                            LD2

025020                                    42                                                            LD2

025103                                    41                                                            LD2

025114                                    40                                                            LD2

025126                                    35                                                            LD1

025210                                    32                                                            LD

025220                                    12                                                            LD1

025620                                    25                                                            LD2

025843                                    28                                                            LD1

026221                                    33                                                            LD

026222                                    34                                                            LD

026318                                    6                                                              LD

029809                                    33                                                            LD

031323                                    9                                                              LD

034605                                    42                                                            LD1

034619                                    14                                                            LD1

034708                                    27                                                            LD

108005                                    42                                                            LD2

108038                                    42                                                            LD2

108101                                    27                                                            LD2

108102                                    41                                                            LD2

108223                                    7                                                              LD

110806                                    24                                                            LD

110917                                    27                                                            LD1

112225                                    35                                                            LD2

112401                                    30                                                            LD1

114321                                    42                                                            LD2

114322                                    23                                                            LD2

116525                                    26                                                            LD2

116311                                    34                                                            LD

117934                                    34                                                            LD1

120708                                    42                                                            LD2

120709                                    42                                                            LD2

120815                                    22                                                            LD2

120818                                    31                                                            LD1

121318                                    32                                                            LD

124002                                    39                                                            LD2

126423                                    19                                                            LD2

126424                                    42                                                            LD2

126425                                    42                                                            LD2

126426                                    28                                                            LD1

129010                                    42                                                            LD2

129028                                    40                                                            LD2

129108                                    28                                                            LD2

129502                                    33                                                            LD1

Escalon Customer Lot Information:

Transfill Lot #       Quantity Released                                               Size

021504                                    41                                                            LD1

021616                                    42                                                            LD1

021738                                    41                                                            LD1

022433                                    16                                                            LD1

025802                                    42                                                            LD1

025807                                    42                                                            LD1

025924                                    42                                                            LD1

025902                                    42                                                            LD1

025903                                    42                                                            LD1

025904                                    42                                                            LD1

026201                                    42                                                            LD1

026202                                    41                                                            LD1

034103                                    42                                                            LD1

034104                                    30                                                            LD1

101019                                    17                                                            LD1

101020                                    15                                                            LD1

101127                                    28                                                            LD1

101133                                    14                                                            LD1

108504                                    22                                                            LD1

108711                                    28                                                            LD1

112914                                    33                                                            LD1

115001                                    42                                                            LD1

121319                                    41                                                            LD1.

RECALLING FIRM/MANUFACTURER Scott Medical Products, Plumsteadville, PA

REASON Post-operative warning against use of nitrous oxide gas before intraocular gas has dissipated from the eye.

VOLUME OF PRODUCT IN COMMERCE 2900 cylinders/ 2nd notification: 4205 cylinders.

DISTRIBUTION Nationwide.

 

PRODUCT Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL.

CODE Product codes 2L3107 and 2L3107R, all serial numbers.

RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL.

Manufacturer: Baxter Healthcare Pte. Ltd., Singapore, SG.

REASON Software anomaly allows access to change prescription or program bolus without security.

VOLUME OF PRODUCT IN COMMERCE 9,927 pumps.

DISTRIBUTION Nationwide.

 

PRODUCT Boston Scientific/Medi-Tech Dual Lumen Vaxcel PICC (Peripherally Inserted Central Catheter) as follows:

Catalog Number   Product Description                  

a) 45-413                VAXCEL 5F DUAL LUMEN PICC;

b) 45-426                 VAXCEL 6F DUAL LUMEN PICC;

c) 45-445                PICC VAXCEL 5F DL/CLAMPABLE/60CM WIRE/OB;              

d) 45-446                PICC VAXCEL 6F DL/CLAMPABLE/60CM WIRE/OB

CODE

Lot Numbers

a) 628022A, 626091AR, 604101AR; b) 611032B, 618032B; c) 628022B, 611032C; d) 611032C

RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp./Medi-Tech, Watertown, MA

Manufacturer: Medsource Technologies LLC, Navajoa, Sonora.

REASON Catheter Extension tube detached from hub upon being flexed.

VOLUME OF PRODUCT IN COMMERCE 5,214.

DISTRIBUTION Nationwide.

 

PRODUCT Vaxcel Single Lumen Peripherally Inserted Central Catheter (PICC) as follows:

Catalogue Number               Description

a) 45-430                                4F SL/Clamp/130 cm PICC;

b) 45-432                                5F SL/Clamp/130 cm PICC. 

CODE Lot Number a) 605121A, 608111B; b) 628081A.

RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp.Medi-Tech, Natick, MA

Manufacturer: Medsource Technologies LLC, Navajoa, Sonora.

REASON Guidewire is incorrectly coiled in protective hoop with luer fitting at wrong end.

VOLUME OF PRODUCT IN COMMERCE 1112 units.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT

a) Model IM2  Licox Bolt System, Double Lumen

b) Model IM3 Licox Bolt System, Triple Lumen

c) Model IM2.S  Complete Licox Probe Kit, Double Lumen

d) Model IM3.S  Complete Licox Probe Kit, Triple Lumen

e) Model Im3.ST  Complete Licox Probe Kit with Temperature Probe, Triple Lumen

CODE a) Lots 050301A, 290301A, 120501, 151200, 160101A;

b) Lots 261101, 271101, 151200, 050301A, 290301B, 31101,181001, 040101A, 140401, 150601, 120501, 51001, 260101A,290301A, 160601;

c) Lots 02449, 02649, 02751, 02883, 02539, 02680, 02780, 02889, 02604, 02731, 02813, 02920;

d) Lots 02441, 02748;

e) Lots 02416, 02478, 02550, 02666, 02722, 02765, 02778, 02829, 02847, 02890, 02419, 02508, 02561, 02696, 02747, 02766, 02789, 02838, 02856, 02900, 02432, 02522, 02620, 051001,02755, 02773, 02796, 02842, 02879, 02904.

RECALLING FIRM/MANUFACTURER Integra Neuro Care LLC, San Diego, CA

REASON Catheter/ bolt incompatibilty may result in erroneous intracranial pressure measurements.

VOLUME OF PRODUCT IN COMMERCE 388 bolts.

DISTRIBUTION Nationwide.

 

PRODUCT Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting.  Model 110-4L.

CODE All lots.

RECALLING FIRM/MANUFACTURER Integra Neurocare LLC, San Diego, CA

REASON Catheter collapse may result in erroneously high pressure readings.

VOLUME OF PRODUCT IN COMMERCE 44 estimated in distribution.

DISTRIBUTION Nationwide.

 

PRODUCT GE Signa .5T, 1.0T, and 1.5T MR/I Extremity coils.

CODE All serial numbers are affected. 

RECALLING FIRM/MANUFACTURER General Electric Medical Systems, Waukesha, WI

REASON Extremity coil pads could catch on fire and burn patient.

VOLUME OF PRODUCT IN COMMERCE 2573 devices.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Ti cann Troch Fixation Nail (Trochanteric Fixation Nail). The responsible firm on the label is Synthes USA, Monument, CO.

CODE 456.315S, lot 4381555 expiration date March 19, 2011

456.318S, lot 4381514 expiration date March 19, 2011.

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

Manufacturer:  Synthes (USA), Monument, CO.

REASON Manufactured outside design specification.

VOLUME OF PRODUCT IN COMMERCE 16 units.

DISTRIBUTION AZ, CO, FL, MO, MS, OR, PA and TX.

 

PRODUCT Choice A.B. (aberation blocking) Daily wear soft (hydrophilic) contact lens.  The product is packaged in trial and multipacks.

CODE Lot No. 0620, 1016, 1009, 0912, 0924, 0925, 0926, 1025, 1004, 0926, 1015, 0829, 0912, 1023, 0912, 0921, 0717, 0916, 10620, 11025, 10823, 10730.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Ciba Vision Corp., Duluth, GA.

Manufacturer:  Specialty Ultravision, St. Hubert, Quebec, Canada.

REASON The polymer was undercured, lens may appear cloudy.

VOLUME OF PRODUCT IN COMMERCE 781 units.

DISTRIBUTION Nationwide.

 

PRODUCT a)Cardiac/ Peritoneal Catheter, Standard Barium Impregnated,    90cm Catalog No. 43103;

b) Peritoneal Catheter, Open end with wall slits, Standard,    Barium impregnated, 90 cm, Catalog No. 43522.

CODE a)Catalog Number 43103, Product lots Y1953 and Y1954; b)Catalog Number 43522, Product lots Y1955 and Y1956.

The first catalog number product and lots are contained in the second catalog number product and lots packaging and labeling.

RECALLING FIRM/MANUFACTURER Medtronic Neurosurgery, Goleta, CA

REASON Product Mix-up/ Substitution/ Mislabeling.

VOLUME OF PRODUCT IN COMMERCE 219.

DISTRIBUTION Nationwide and Canada, Australia and Korea.

 

PRODUCT Bone Stack        Calcium Sulfate

CODE Catalog No.  6184-5-050; 6184-5-100; 6184-5-200; 6184-3-200; 6184-3-400.

Lot Code: 95181; 95799A; 95799; 95905A; 95803; 958051; 95805; 958061; 95806.

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

Manufacturer: Stryker Howmedica Osteonics Limerick, Ireland.

REASON Volume of pellets is less than listed on the labeling.

VOLUME OF PRODUCT IN COMMERCE 193 units.

DISTRIBUTION Nationwide.

 

PRODUCT Hemashield Gold Woven Double Velour 4-Branch Vascular Graft in 28 and 30mm sizes.  Catalog Number 175928 and 175930.

CODE For the 28mm size: Lot 4019302RW  For the 30mm size: Lot 3743489RW.

RECALLING FIRM/MANUFACTURER Boston Scientific Corp./Medi-Tech Wayne, NJ

REASON 28 and 30mm sizes were mislabeled.

VOLUME OF PRODUCT IN COMMERCE 17 -- 28mm size; 17 -- 30mm size.

DISTRIBUTION Nationwide.

 

WEEK ENDING AUGUST 10

 

PRODUCT 1.5T MR Systems with software version R7.1.2 and higher: Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremeties.  These images and/or spectra, when interpreted by a trained physician, yeild information that may assist in diagnosis.  The coils are used to obtain optimal imaging. 

CODE Release 6.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Philips Medical Systems North America, Inc., Bothell, WA.

Manufacturer:  Philips Medical Systems, Nederland B.V. Netherlands. 

REASON Higher than expected current in the insulation of the coil cable.

VOLUME OF PRODUCT IN COMMERCE 3.

DISTRIBUTION FL and WA.

 

WEEK ENDING AUGUST 17

 

PRODUCT CAPTIA Syphilis G ELISA Test Kit For in vitro diagnostic use. Packed in kits of 96 determinations and kits of 960 determinations.

CODE Lot numbers:

K00841, Exp. 14 JAN 03

K00842, Exp. 14 JAN 03

K00839, Exp. 14 JAN 03

K00838, Exp. 14 JAN 03

(these may be suffixed by a letter)

Product codes:

800-925, 96 tests per kit

801-030, 960 tests per kit

801-032, 96 tests per kit

801-033, 960 tests per kit.

RECALLING FIRM/MANUFACTURER Trinity Biotech plc Co., Wicklow, Ireland

REASON Potential false negative results.

VOLUME OF PRODUCT IN COMMERCE 292 units.

DISTRIBUTION CA, FL, MN, NJ, and PA. 

 

PRODUCT a)Calcium reagent for Hitachi Modular P analyzer, catalog no. 1730240.

b)Calcium reagent for Hitachi Modular P and D analyzers, catalog nos. 1929780 and 1929798.

c)Calcium reagent for Hitachi Modular D analyzer, catalog nos. 1929801 and 1929828

d)Calcium reagent for Hitachi Model 704, 717, 902, 904, 911, 912 and 914 analyzers, catalog no. 1489216.

e)Calcium reagent for Hitachi Model 717, 904, 911, 912 and 914 analyzers, catalog no. 1125621.

f)Calcium reagent for Hitachi Model 736, 737 and 747 analyzers, catalog nos. 1127551 and 1127560.

g)Calcium reagent for Hitachi Model 747-400 analyzers, catalog nos. 1554352 and 1554352.

h)Cobas INTEGRA 400, 700, and 800 calcium reagent, Art 0763128; catalog no. 2055716.

CODE All lots.

RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN, by letter dated 4/10/02.  Firm initiated recall is complete.

REASON MRI contrast media interferes with calcium test results.

VOLUME OF PRODUCT IN COMMERCE 2,867 analyzers.

DISTRIBUTION Nationwide.

 

PRODUCT e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations.

CODE e.soft software version 2.0 installed on e.soft A and e.soft A/P workstations.

RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Hoffman Estates, IL

REASON Incorrect image time stored for static images resulting in incorrect results.

VOLUME OF PRODUCT IN COMMERCE 346 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT OEC MiniView 6800 Mobile C-arm X-ray system.

CODE OEC MiniView 6800 Mobile C-arm. 369 units within the Serial Number range 86-0009 thru 86-0798.

RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT

REASON Unit may become unbalanced and tip when the C-arm assembly is extended.

VOLUME OF PRODUCT IN COMMERCE 369.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT CODE BLUE, PEDI BLUE, and BABY BLUE line of manual resuscitators.

CODE Model Numbers: 72054, 7500, 7500JACK, 7500K, 75045, 7505, 7505E, 7505EK, 7505EK9, 7505K, 7550, 7550A, 7550E, 7550EK, 7550K, 7550K9, 7550T9, 7552, 7552K, 7800, 7800JACK, 7800R, 7800R79, 7803, 7803R, 7830, 7830R, 7830T9, 7834, 7834A, 7840, 7868R, 78689, 7900, 7900JACK, 7900R, 7900R79, 7900T, 7902, 7902R, 7910, 7910A, 7910R, 7920, 7920C, 7920P9, 7920R, 7920S, 7920T, 7921, 7921AT9, 7921CNPT, 7921CP, 7921OSHU, 7921R, 7921S, 7921T, 79249.

Lot Numbers: All lot codes beginning with "D" and "E" 001 through 365 and those beginning with "F" and "H" 001 through 106.

RECALLING FIRM/MANUFACTURER Vital Signs, Inc., Totowa, NJ

REASON Failures due to air/oxygen leakage.

VOLUME OF PRODUCT IN COMMERCE 227,580.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Disposable Bipolar Cable, sterile, 12 foot, packaged in pouch, under the Q2 MEDICAL label, 10 pouches per case.

CODE Lot Number 108932    Part Number 20-1102.

RECALLING FIRM/MANUFACTURER Olsen Medical, Louisville, KY

REASON Device may not be sterile due to packaging defect.

VOLUME OF PRODUCT IN COMMERCE 2,650 units.

DISTRIBUTION NM, WA, VA, MI, NY, PA, TX, OK and TN.

 

PRODUCT MedComp Custom Dialysis Trays/Kits. The trays/kits are prep trays that do not contain a catheter. The trays/kits contain Wyeth's Heparin 1000 units/ml 1 ml dosette vial.

CODE Catalog Number Tray #614JR Lot Number M001070;

Catalog Number Tray #322 Lot Number M001520;

Catalog Number Tray #500 Lot Number M002000;

Catalog Number Tray #119 Lot Number M002370;

Catalog Number Tray #273 Lot Number M005780;

Catalog Number Tray #328 Lot Number M008600;

Catalog Number Tray #119 Lot Number M010740;

Catalog Number Tray #163 Lot Number M012680;

Catalog Number Tray #119 Lot Number M013230;

Catalog Number Tray #322 Lot Number M015930;

Catalog Number Tray #119 Lot Number M016860;

Catalog Number Tray #293 Lot Number M017120;

Catalog Number Tray #163 Lot Number M017520;

Catalog Number Tray #614JR Lot Number M017980;

Catalog Number Tray #163 Lot Number M018350;

Catalog Number Tray #328 Lot Number M020250;

Catalog Number Tray #163 Lot Number M020260;

Catalog Number Tray #498 Lot Number M021920;

Catalog Number Tray #163 Lot Number M024150;

Catalog Number Tray #163 Lot Number M029170;

Catalog Number Tray #500 Lot Number M032740;

Catalog Number Tray #273 Lot Number M033590;

Catalog Number Tray #163 Lot Number M034030;

Catalog Number Tray #328 Lot Number M034060;

Catalog Number Tray #163 Lot Number M034250;

Catalog Number Tray #3 Lot Number M036190;

Catalog Number Tray #293 Lot Number M038260;

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Catalog Number Tray #273 Lot Number M209420;

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