WEEK ENDING AUGUST 6

PRODUCT Marquette Clinical Information Center Software. The Clinical Information Center displays data from up to 16 patient monitors.
CODE Version V1.4 and all previous versions of the software.
MANUFACTURER Marquette Medical Systems, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Nationwide, Canada, France, Australia, Italy, Sweden.
QUANTITY 368 units were distributed.
REASON Defective software could result in failure to give warning.

PRODUCT a) Viscoat Viscoelastic Solution, 0.5 ml, Catalog Number 8065-1839-05 PMA P840064; b) Duovisc Viscoelastic System, 0.5 Ml, Catalog Number 8065-1831-05.
CODE Lot Numbers: a) 57010P and 57443P; b) 57446P.
MANUFACTURER Alcon Puerto Rico, Inc., Humacao, Puerto Rico.
DISTRIBUTION Nationwide.
QUANTITY 36,390 units were distributed.
REASON Product was distributed without the cannula locking ring.

PRODUCT Lifestyles & Contempo Assorted Colors Lubricated Condoms Model: Contempo Intensity Assorted Colors Condoms Product Code 4535 & 4560; Lifestyles Assorted Colors Lubricated Product Code 5303/605149.
CODE Contempo Intensity Assorted Colors Condoms Lot Number 0805718400 Product Code 4535 Display Racks (Master Lot 0905000102). Each display rack contains 5 boxes of Contempo Intensity Assorted Colors Condoms (Lot Number 0805718400) Expiration Date 05/2001 Product Code 4560 Lifestyles Assorted Colors Lubricated Lot Number 0805718500 Lot Number 0805718800 Expiration Date 05/2001 Product Code 5303/605149.
MANUFACTURER Ansell, Inc., Dothan, Alabama.
DISTRIBUTION California, North Carolina, New York, Pennsylvania, Florida, and international.
QUANTITY 1,465 gross were distributed.
REASON Holes were discovered in condoms during a routine monitoring by the State of North Carolina.

PRODUCT Eclipse LE II Electrocardiograph, Model 92304.
CODE Serial Numbers: 10690000007 to 10690000009, 10690000011 to 10690000051, 10690000055 to 10690000131, 10690000144, 10690000153, 10690000154, 10690000157, 10690000158, 10690000166 to 10690000171, 1070000003.
MANUFACTURER Spacelabs Burdick, Inc., Deerfield, Wisconsin.
DISTRIBUTION Nationwide and Taiwan.
QUANTITY 133 devices were distributed.
REASON The ground wire of the device could fail, due to "over-crimping".

PRODUCT Orthogonal Electrophysiology Catheters: a) Fixed, 6 French (F); b) Deflectable, 7F;
c) Deflectable, 6F; d) Deflectable, 8F; e) Mansfield Fixed, 6F, Catalogue No. 5211.
CODE Catalog numbers: a) OF-6G-005-MS, OF-6F-010-MO, OF6-3X4F-010-MO, OF6-3X4G-010-MS, OF6-3X4F-005-MS, OF6-5X2D-010-FO; b) OD-7D-010-MS, OD7-8X2D-005-FS, OD7-3X4D-010-MS, 1095-24-S, 1097-184-S; c) OD6-3X4G-010-MS; d) OD8-8X2-010-FS; e) 5211.
MANUFACTURER Paragon Healthcare Corporation, Spartanburg, South Carolina (reprocessor).
DISTRIBUTION Arkansas, Kansas, North Carolina, Oregon, Pennsylvania, Texas.
QUANTITY 72 catheters.
REASON An electrode may separate from the catheter, while it is being separated from a patient.

PRODUCT a) Medtronic DBS Lead Kits for Deep Brain Stimulation, Model Nos. 3382, 3387,3387RES, and 3389;
b) Medtronic Customer Engineered Burr Hole Cap and Ring, Model Nos. 3350SP and 3350SPJ.
CODE All lots.
MANUFACTURER Medtronic, Inc., Neurological Division, Minneapolis, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 5,557 lead kits and 110 burr hole caps were distributed.
REASON There are visible chemical residues on some of the Burr Hole Caps through which the leads are inserted.

PRODUCT Surgidyne VariDyne Vacuum Controller and Collection System, Model 350-2id, a portable powered aspiration pump used for closed wound, surgical sump, nasogastric and other tube drainage.
CODE Model 350-2id with serial numbers: 81111, 81112, 81113, 81114, 81115, and 81116.
MANUFACTURER Surgidyne, inc., Plymouth, Minnesota.
DISTRIBUTION Pennsylvania and Wisconsin.
QUANTITY 6 mislabeled units were distributed.
REASON The devices had incorrect graphics plate.
 

WEEK ENDING AUGUST 13

PRODUCT Medrad Counterpoise System Product Number 75-4000-033.
CODE All Product Manufactured between May 1995 and February 1999.
MANUFACTURER F. Walter Hanel GMBH DBA MAVIG, Munich, Germany.
RECALLED BY Medrad, Inc., Indianola, Pennsylvania
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1,004 units were distributed.
REASON Dowel pins used in support assembly have potential to back out of position.

PRODUCT Screwdriver Blade - Self-Retaining: a) Part 313.922; b) Part 313.923
CODE Lot numbers: a) A4GD466, A4GE246 THRU 251, A4GI665 THRU 666, A4GI985 THRU 986, A4GK114 THRU 116, A4GL610 THRU 934, A4GL985 THRU 986, A4GM750 THRU 751, A4GO312 THRU 313, A4GO695 THRU 696, A4HC274, A4HD827, A4HG576, A4HG670 THRU 672, A4HM425, A4HM603, A4HM622 THRU 624, A4HS178 THRU 180, A4HT467, AND A4HV276; b) A4GE252 THRU 257, A4GL935 THRU 945, A4GP231, A4GP617, A4GQ563, A4HA221, A4HA703, A4HC275 THRU 276, A4HJ489, AND A4HM604 THRU 610.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Nationwide and Canada.
QUANTITY 4,391 units were distributed.
REASON The inspection technique used to inspect the blades had the potential to miss some non-conforming blades. In addition, a tolerance issue was noted between screwdrivers with blades on the lower end of the spec and screw slots on the upper end of the spec.

PRODUCT Holding Sleeve Part #314.06
CODE Lot numbers: A4HM912, A4HQ981, A4HR969, A4HT934, A4HU333, A4HX551, A4HY193, A4HZ523, and A4JA239.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 286 units were distributed.
REASON An operation for crimping the back end of the sleeve was not on the process sheet or specifications for this product.

PRODUCT Wire Tensioner, Part #393.742
CODE Lot numbers: 1008, 1009, 1011 THRU 1018, 1000027, 1000028, 1001644, 1003894.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Nationwide, Canada, Switzerland.
QUANTITY 512 units were distributed.
REASON The wire tensioner may or may not accept a 2.0 mm guide wire.

PRODUCT NPB-190 and NPB-195 Pulse Oximeter, Rx, intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate for use on adult, pediatric, and neonatal patients in hospital and home environments.
CODE All units produced prior to October 9, 1998.
MANUFACTURER Nellcor Puritan Bennett, Inc., Mervue, Galway, Ireland.
RECALLED BY Mallinckrodt, Inc., Hazelwood, Missouri
DISTRIBUTION Nationwide and international.
QUANTITY 9,001 units were distributed.
REASON The devices fail to alarm when a pulse oximetry sensor became disconnected from the patient.

PRODUCT Uro-View X-Ray Imaging Systems: a) Model 2600; b) Model 2500; c) Model 2000
CODE None.
MANUFACTURER OEC Medical Systems, Inc., Salt Lake City, Utah.
DISTRIBUTION Nationwide and international.
QUANTITY 951 units were distributed.
REASON The leg extension can become disengaged and cause a patient to slide to the floor.

PRODUCT 1.3 mm Box Plate: a) Part #421.095; b) Part #421.096
CODE Lot numbers: a) A3LX014; b) A3LX015.
MANUFACTURER Synthes (USA), Monument, Colorado
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION California, Florida, Georgia, Kansas, Kentucky, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, and one international account.
QUANTITY 144 units were distributed.
REASON Plates were switched during processing resulting in a 5x10 mm box plated labeled as a 10x10 mm box plate and vice versa. 5x10 mm is part #421.095 and 10x10 mm is part #421.096.

PRODUCT 7.0 mm Cannulated Screw, 32 mm Thread, 70 mm Length.
CODE Part #209.070, Lot #3008307.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Nationwide and Canada.
QUANTITY 94 units were distributed.
REASON Package is labeled as 7.0 mm cannulated screw, 32 mm thread, 70 mm length. Package actually contains a 7.0 mm cannulated screw, 16 mm thread, 70 mm length.

PRODUCT Synthes (USA) Midfacial System
CODE Part #450-611, Lot #A31D232.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION California, Florida, Maryland, Pennsylvania.
QUANTITY 61 units were distributed.
REASON The device was anodized gold instead of greengray.

PRODUCT Extraction Bolts for 3.5/4.0 screws
CODE Part Number 309.039 - Lot Numbers: 3919791 and 3915138.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 43 units were distributed.
REASON Extraction bolts were misetched with 6.5/7.0 instead of 3.5/4.0

PRODUCT MOX-100 DCM Disposable Organ Preservation Cassette, a sterile, single use, receptacle for transporting kidneys to be used as implanted organs.
CODE Sterile lots 287.296, 460.297, 575.298, 1545.299, and 2252.300.
MANUFACTURER Waters Instruments, Inc., Rochester, Minnesota.
DISTRIBUTION Nationwide and The Netherlands.
QUANTITY 340 cassettes were distributed.
REASON The device sometimes leaks perfusate, a solution used to nourish and chill kidneys, causing a drop in the perfusate level.

PRODUCT Outer Cannula for the C1/C2 Drill Guide
CODE Part #396.372.311, Lot #A4GK253.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Indiana, Massachusetts, Pennsylvania, Washington state, Canada, Switzerland.
QUANTITY 10 units were distributed.
REASON The cannula disengaged from the handle assembly at the solder joint. The solder joint may not be adequate enough to hold the two components together.

PRODUCT Screw/Post for Distractors: a) Part #U44-640-14; b) Part #U44-640-16
CODE Lot numbers: a) A4HN447 THRU 448, A4HN496, A4HP272 THRU 274, A4HP574, & A4HQ604 THRU 606; b) A4HR056, & A4HR058.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 379 units were distributed.
REASON The pin contains features on the back end which prevent it from being inserted into the mating handle.
 

WEEK ENDING AUGUST 20

PRODUCT Various First Aid Kits containing the suspect Povidone-Iodine Pads labeled in part:
1)SAWYER PRODUCTS REMOTE EMERGENCY FIRST AID KIT-NOTE-There is no item number on this product.
2) SAWYER PRODUCTS EMERGENCY FIRST AID KIT**ADVANCED FIRST AID CAPABILITIES**Techniques Preferred by PARAMEDICS & EMERGENCY ROOMS**-NOTE-There is no item number on this product.
3) Sawyer Products FIRST AID TO GO WITH BELT LOOPS ITEM #SP903
4) SAWYER PRODUCTS FIRST AID IN A POUCH**SP905
5) Sawyer Products FIRST AID in a Pouch**10-15 person days**Item #TG905**
6) Sawyer Products FAMILY PACK**ITEM #SP909**
7) Sawyer Products Family First Aid**15-25 person days**Item # TG910**
8) Sawyer Products FAMILY PACK LEVEL 300 **ITEM # SP910**
9) SAWYER INTERMEDIATE FIRSTAID KIT Designed for those who know BASIC FIRST AID ITEM # SP910
10) SAWYER PRODUCTS GROUP PACK Item # SP925**
11) Sawyer Products First Aid Kit**LEVEL 500**For Multi-person excursions and expeditions and for team sports Item # SP926
12) Sawyer Products WOUND CARE module Item #SP932**
13) Sawyer Products LARGE WOUND CARE module Item # SP 933
14) Sawyer Products FOOT CARE module for prevention and treatment of blisters Item #SP934
15) Sawyer Products HUNTING AND FISHING First Aid Kit ITEM #951
16) Sawyer Products LEVEL 600 First Aid Kit Item # SP961
17 Sawyer Products LEVEL 700 First Aid Kit Item # SP962
18) Sawyer Products First Aid Kit DRYBAG Triple Protection of First Aid Supplies Against Exposure to Water Damage** Item # SP973
19) Sawyer First Aid Kit WATERPROOF EXCELLENT FOR WATER TRIPS Item SP 981
20) Sawyer Products FIRST AID watertight case Item #SP985**
21) Sawyer Products FIRST AID to go Note: no item number listed on label
22) Sawyer Products pocket First Aid Item # SP993.
CODE The first aid kits are not coded. Kits were shipped out to direct accounts from 2/1/98 through 4/30/99.
MANUFACTURER SAFFETA, Inc., Safety Harbor, Florida.
RECALLED BY SAFFETA, Inc., doing business as Sawyer Products, Inc., Safety Harbor, Florida
DISTRIBUTION Nationwide and Hong Kong.
QUANTITY 35,672 kits that may have the subject pads were distributed.
REASON The kits may contain non-sterile Povidone Iodine pads.

PRODUCT MNPB Ventilator and Graphic User Interface (GUI), CPU Board and Breath Delivery Unit (BDU), CPU Board Assemblies Model #840, a dual-microprocessor electronic system for use to provide precise breath delivery for critically ill infant, pediatric, and adult patients.
CODE
The recalled part numbers associated with the hardbody (i.e., BDU/GUI) ventilators are as follows:
4-NPB840-DL; 4-075166-00; 4-075167-00; 4-075168-00; 4-075169-00; 4-075170-00; 4-075276-00; 4-075277-00; 4-075278-00; 4-075279-00; 4-075280-00; 4-075391-00; 4-075165-00;
The recalled part numbers associated with the spare Printed Circuit Boards/CPU boards are as follows:4-073200-SP; 4-070950-SP.
MANUFACTURER Mallinckrodt Nellcor Puritan Bennett (MNPB), Carlsbad, California.
DISTRIBUTION Nationwide and international.
QUANTITY 725 units were distributed.
REASON The voltage regulator may manifest by not allowing control changes to be passed from the GUI onto the BDU and/or overheating with resultant heat or smoke.

PRODUCT Intermediate Hi-Lo Pre-Cut Tracheal Tube with Stylet, for airway management by oral intubation of the trachea.
CODE Catalog #86118, Lot #M032120.
MANUFACTURER MMJ SA de CV (Mallinckrodt Medical), Juarez, Mexico.
RECALLED BY Mallinckrodt, Inc., St. Louis, Missouri
DISTRIBUTION California, Utah, Minnesota.
QUANTITY 250 units were distributed.
REASON The incorrect stylet was used and is too long, extending beyond the tip of the tube.

PRODUCT CPI Endotak DSP Implantable Leads: a) Model 0095; b) Model 0125
CODE All serial numbers less that 230000.
MANUFACTURER Guidant Corporation, St. Paul, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 29,500 were distributed,
REASON The lead is bent sharply away from the header block, the integrity of the lead and/or lead insulation can be compromised.

PRODUCT Alcon Surgical Procedure Packs Custom Pak: a) Product #4345-12; b) #6899-03
CODE a) Lot Code 95801H; b) Lot Code 97286H.
MANUFACTURER Alcon Laboratories, Houston, Texas. DeRoyal, Rose Hill Virginia (light handle covers).
RECALLED BY Alcon Laboratories, Inc., Fort Worth, Texas
DISTRIBUTION California and Florida.
QUANTITY a) 8 units; b) 10 units were distributed.
REASON Light handle covers did not fit properly onto the light handle. Further, the poor fit might cause the light handle cover to be too loose which might result in the cover falling off the handle in the sterile field or cause the cover to be too tight which might result in the cover splitting during use.

PRODUCT Intermedics single and dual-chamber pulse generators
1. Cosmos II, Model Nos. 283-03, 284-05;
2. Cosmos 3, Model Nos. 283-09, 284-09;
3. Dart, Model No. 292-05;
4. Dash, Model Nos. 291-03, 292-03, 292-03R;
5. Intertach II, Model Nos. 262-16, 262-16R;
6. Marathon-Edgeband, Model Nos. 292-09E, 293-09E, 294-09E;
7. Marathon DR, Model Nos. 293-09, 294-09, 294-09R, 294-10;
8. Marathon Z, Model No. 294-09Z;
9. Marathon SR, Model Nos. 291-09, 292-09R, 292-09X, 292-09Z;
10. Momentum DR, Model Nos. 294-23, 294-23E, 294-23Z;
11. Nova III, Model Nos. 281-07, 282-07, 282-09.
12 Quantum III, Model No. 254-27;
13. Relay, Model Nos. 293-03, 293-09E, 294-03, 294-03R;
14. Relay-Edgeband, Model Nos. 293-03E, 294-03E;
15. Stride, Model No. 294-05;
16. Suprima III, Model No. 254-31;
17. Unity-C, Model No. 292-06;
18. Unity, Model No. 292-07;
19. Custom Device, Model No. 82-0015-2801.
CODE 8,598 units within the serial number range 01068/253784.
MANUFACTURER Intermedics, Inc., doing business as Guidant Intermedics, Angleton, Texas.
DISTRIBUTION Nationwide and international.
QUANTITY 8,598 units were distributed.
REASON The pulse generators were shipped from the factory with a pulse amplitude.that did not match the inquired nominal value as reported by the programmer.

PRODUCT Bio-Interference Screw, 8mm size
CODE Model 1380B, Lot #13258.
MANUFACTURER Arthrex Arthroscopy Instruments, Inc., Naples, Florida.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,786 units were distributed.
REASON Screws may crack during insertion.

PRODUCT Pedicle Screw is a component of the VSP Spinal Fixation System.
CODE Product Code: 2226-2835, Lot S4578.
MANUFACTURER Depuy Acromed, Raynham, Massachusetts.
DISTRIBUTION Colorado, Australia, Austria, Italy, and Hong Kong.
QUANTITY 118 units.
REASON The device was incorrectly labeled 6.25 mm diameter/titanium vs. actual product 7.0 mm stainless.
 

WEEK ENDING AUGUST 27

PRODUCT AngioCOMM Workstation (previously StatVIEW)
1. AngioCOMM Review Station reviews and analyzes angiographic injection image sequences acquired by the Network Interface Station or by downloading DICOM studies from a CD-ROM:
a) AngioCOMM Single Sequence Review Station;
b) AngioCOMM Mobile Review Station;
2. AngioCOMM Network Interface Station (NIS) provides the capability to capture, review, and archive coronary injection sequence images from an x-ray system in the cath lab:
c) AngioCOMM Single Sequence Network Interface Station, Pentium Pro
d) AngioCOMM Single Sequence NIS Pentium.
CODE
a) Catalog #00406-003, Serial #s 901130, 901171, 931143
b) Catalog #00411-001, Serial #s 107, 109 Catalog #00411-003, Serial #s 101, 102, 103, 143, 145 Catalog #00411-005, Serial #101
c) Catalog #00429-001, Serial #s 101, 104 Catalog #00429-003, Serial #s 143, 144, 154
d) Catalog #31740-001, Serial #s 901169, 901170.
MANUFACTURER Quinton Instrument Company, Bothell, Washington.
DISTRIBUTION Alabama, New York, Texas, West Virginia, Washington state.
QUANTITY 11 Review Stations and 7 Sequence NIS Stations were distributed.
REASON Under certain specific circumstances, sequences of a single plane study may overlap sequences of bi-plane study when viewing both on the AngioCOMM Single Sequence Review Station or the Single Sequence Network Interface Station (NIS).

PRODUCT Light Handle Covers, single use cover for OR light handles to maintain sterility during OR procedures, sold in single and multi-packs and as a component in surgical trays.
CODE 116 lots manufactured from 4/1/99 to 6/25/99.
MANUFACTURER Atlanta Thermoplastics, Tucker, Georgia.
RECALLED BY Deroyal Surgical, Rose Hill, Virginia
DISTRIBUTION Nationwide.
QUANTITY 631,000 covers were distributed.
REASON Surgical device cover on handle may come off and compromise sterility during surgery.

PRODUCT Hoyer Power Lifter Actuators, a 12 volt DC electromechanical device marketed as a component of several patient lifting devices, part of a retrofit kit for unpowered patient lifting devices or as a stand alone component:
a) Model No. 59105, Retro-fit Power Conversion Kit;
b) Model No. 53005, Power Partner Lifter;
c) Model No. 53006, Power Partner Stand-Assist Hoyer Lifter;
d) Model No. P-C-HLA, Power Chrome Lifter;
e) Model No. 400-2543 - Assigned to kit that includes the motor/ballscrew assembly, the battery charger and the hand control;
f) Model No. 400-2546 - assigned to the motor/ballscrew assembly (Actuator only);
g) Model No. 400-2384, Replacement Battery Pack.
CODE All serial numbers.
MANUFCTURER Scanac of Sweden acquired in 1998 by Warner Electric, AB, Partille, Sweden.
RECALLED BY Sunrise Medical Home Healthcare Group, Inc., Chula Vista, California
DISTRIBUTION Nationwide, Puerto Rico, Thailand.
QUANTITY 1,803 units, representing the actuators, were shipped. The actuators were situated in finished products.
REASON A short circuit in the system will cause the batteries to discharge, resulting in the generation of heat which may cause fire, fumes, smoke or loss of power.

PRODUCT Bennett Contour2, Stereotactic Ready Mammography Machine, an x-ray device.
CODE BMC-27993 BMC-27915 BMC-28168 BMC-27920 BMC-27837 BMC-28042 BMC-28128 BMC-27809 BMC-27973 BMC-28000 BMC-28054 BMC-28151 BMC-28231 BMC-27990 BMC-27831 BMC-28051 BMC-28136 BMC-27768 BMC-27944 BMC-27996 BMC-28050 BMC-27987 BMC-27823 BMC-27759 BMC-28118 BMC-27896 BMC-27936 BMC-27931 BMC-27754 BMC-27889 BMC-27600 BMC-27801 BMC-27841 BMC-27842 BMC-27803 BMC-27739 BMC-27927 BMC-27985 BMC-27771 BMC-27741 BMC-27942 BMC-28141 BMC-28183 BMC-27904 BMC-28223 BMC-27871 BMC-27998 BMC-27637 BMC-28187 BMC-27828 BMC-28182 BMC-27772 BMC-27848 BMC-28190 BMC-27914 BMC-28005 BMC-28046 BMC-27762 BMC-28230 BMC-28109 BMC-28110 BMC-27943 BMC-28094 BMC-28052 BMC-28176 BMC-27611 BMC-28098 BMC-28099 BMC-28185 BMC-27850 BMC-27855 BMC-27925 BMC-27834 BMC-28063 BMC-27846 BMC-28019 BMC-28116 BMC-28126 BMC-28133 BMC-28134 BMC-28188 BMC-28253 BMC-28219 BMC-28224 BMC-27909 BMC-27961 BMC-27962 BMC-28022 BMC-28152 BMC-27778 BMC-27805 BMC-27891 BMC-27957 BMC-28067 BMC-28074 BMC-29160 BMC-29007 BMC-29021 BMC-29055 BMC-29081 BMC-29129 BMC-29144 BMC-29113 BMC-29152 BMC-29131 BMC-29161 BMC-29022 BMC-29125 BMC-29130 BMC-29061 BMC-29073 BMC-29174 BMC-29119 BMC-29122 BMC-29162 BMC-29137 BMC-29156 BMC-29008 BMC-29028 BMC-29078 BMC-29115 BMC-29063 BMC-29082 BMC-29132 BMC-29049 BMC-29172 BMC-29173 BMC-29179 BMC-29056 BMC-29116 BMC-29133 BMC-29184 BMC-29080 BMC-29023 BMF-25723 BMF-25725 BMF-25735 BMF-26541 BMF-25808 BMF-26082 BMF-26498 BMF-26133 BMF-26517 BMF-26169 BMF-26494 BMF-26193 BMF-26275 BMF-26337 BMF-26372 BMF-26530.
MANUFACTURER Trex Medical Corporation, Copaigue, New York.
DISTRIBUTION Nationwide and international.
QUANTITY 154 units were distributed.
REASON The subtray mandrels (pins) used to attach the mammography Bucky tray or the optional Cytoguide to the vertical C-Arm of the mammography machine can, overtime, become loose or bend and break.

PRODUCT Apligraft (Graftskin), indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficiency of greater than 1-month duration which has not adequately responded to conventional therapy.
CODE Unit Numbers: 68, 69, 71, 73, 74, 76, 78, 80 through 83, 87 through 89, 91, 99. Lot #GS9906.08.02 EXP 07/04/99.
MANUFACTURER Organigenesis, Inc., Canton, Massachusetts.
DISTRIBUTION Alabama, Arizona, Florida, Massachusetts, Minnesota, Washington state, Texas.
QUANTITY 16 units were distributed for commercial use.
REASON Burkholderia cepacia contamination.

PRODUCT ITI Extender System Octa Abutment (also referred to as the Bone Graft Octa Abutment, H 2.1 mm) a component of the ITI Extender System.
CODE Catalog Number: 048.426, Lot #1010.
MANUFACTURER Institut Sraumann AG, Waldenbrug, Switzerland.
RECALLED BY The Straumann Company, Waltham, Massachusetts
DISTRIBUTION Connecticut, Iowa, Florida, Minnesota.
QUANTITY 27 units were distributed.
REASON Potential for abutment to fracture due to error on the tolerance value for the depth of the hole on the modified engineering drawing.

PRODUCT Shiley Adult Tracheostomy Tubes, intended for use in providing tracheal access for airway management:
a) Catalog Nos. DCT, DFEN, DCFS, DCFN, & PERC;
b) Catalog Nos. LPC, FEN, CFN, CFS, & LGT.
CODE Lot Numbers: a) M80233000 through M86559000, M88059000 & M88080000; b) M85013000 through M86544000, M88053000, M88054000, M88055000, M88058000, M88073000, M88074000, M88049000, & M88293000.
MANUFACTURER Mallinckrodt, Inc., Irvine, California.
DISTRIBUTION Nationwide and international.
QUANTITY 263,246 tubes were distributed. Firm estimated that little product remained on market at time of recall initiation.
REASON The lug pin, which hold the soft swivel flange to the cannula may break, causing displacement of the flange.

PRODUCT Synchron Systems Digoxin Reagent, Catalog No. 650182, used in conjunction with the SYNCHRON Systems Drug Calibrator 2 set and is intended for the quanitative determination of total digoxin concentration in human serum or plasma on SYNCHRON CX Systems.
CODE Lot numbers: M810065 EXP 30Nov00, M901265 EXP 28Feb01, and #M904060, EXP 31May01.
MANUFACTURER Beckman Coulter, Carlsbad, California.
RECALLED BY Beckman Coulter, Inc., Brea, California
DISTRIBUTION Nationwide and International.
QUANTITY 2,554, units of lot M810065, 1917 units of lot M904060 and 678 units of M901265 were distributed.
REASON The devices may produce false low digoxin results.

PRODUCT Heart Valve Harvested from a cadaveric donor.
CODE Donor ID #33986.
MANUFACTURER New York Organ Donor Network (NYODN), New York, New York.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON The specimen collected from donor was found to be repeatedly reactive for HbsAg.

PRODUCT Sorin Blood Cardioplegia Console, Model BCC-02, Part #R DP48-0001-102, designed for use during cardiopulmonary bypass procedures to control the introduction of blood and crystaloid delivery in the management of cardioplegia delivery.
CODE Serial numbers:
02960020R 04960037 06960053R 0890071R 02970088R 02960021R 04960038 06960054 12960073R 02970089 02960022R 04960039 06960055R 12960074 03970090R 02960023R 04960040R 06960056 12960075R 02970092R 02960024 04960041 06960057 12960076R 03970095R 02960025 04960042R 06960058R 12960077 03970097 02960026 04960043 06960059 12960078R 03970098 02960028 04960044 06960062R 12960079R 03970099R
02960029R 04960045R 08960063 12960080R 03970100R 02960030 04960046 08960064 12960081 03970101R 04960031R 04960047R 08960065 12960082R 03970102R 04960032R 04960048R 08960066R 02970083 03970103R 04960033R 04960049R 08960067R 02970084R 04960034R 06960050 08960068 08960072R 03970105R 04960035R 06960051R 08960069R 02970086 03970107R 04960036R 06960052R 08960070 02970087 03970109R.
MANUFACTURER Seamed Corporation, Redmond, Washington.
RECALLED BY Sorin Biomedical, Inc., Irvine, California
DISTRIBUTION Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, Missouri, Nebraska, Pennsylvania, Rhode Island, Texas, Washington state, Canada, Italy, Japan.
QUANTITY 80 Units were distributed.
REASON The device may deliver the blood/cardioplegia solution at uncontrolled high speed (overspeed pump condition).

PRODUCT Omega Plus Compression Hip Screw System with varied product codes:
a) Product Code 33630304; b) Product Code 33630305; c) Product Code 33630354; d) Product Code 33630355; e) Product Code 33630405; f) Product Code 33630454; g) Product Code 33630455; h) Product Code 33631002; i) Product Code 33631002; j) Product Code 33631004; k) Product Code 33631004; l) Product Code 33631005; m) Product Code 33631008; n) Product Code 33631102; o) Product Code 33631103; p) Product Code 33631106; q) Product Code 33631108; r) Product Code 33631204; s) Product Code 33631306; t) Product Code 33631406.
CODE Lot numbers: a) C6JYB; b) C6JYA; c) BXYPJH, BXYPJG; d) BXYPOH; e) C6KBL; f) C6KDA; g) C6KED; h) BXYPKEA; i) C6JWH, C6JWG; j) BXYPKA; k) C6JWE; l) C6JWJ; m) C6KGA, C6KGB; o) BXYPKE; p) BXYPKF, BXYPKG, BXYPML, BZFBMC, BZFBMD; q) BXYPKC; r) C5ACC, C6GZE; s) C6KAA, C6KAC; t) C6KEH; u) C6KFA;
MANUFACTURER Pfizer Hospital Products Group, Howmedics, Inc. Rutherford, New Jersey.
RECALLED BY Howmedica Osteonics Corporation, Rutherford, New Jersey
DISTRIBUTION Korea, Ireland and Canada.
QUANTITY 1,218 were distributed.
REASON The inner dimension of the sideplate had dimensions that were too small, resulting in the sideplate not sliding fully into the lag screw.

PRODUCT Series 7000 Total Knee Modular Tibial Tray, a component of the Total Knee System, implanted into a patient along with other knee system components as part of a knee replacement.
CODE Catalog #7376-0005, Case Code T98T477.
MANUFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey.
DISTRIBUTION Florida, Massachusetts, Michigan, North Carolina, New York, England.
QUANTITY 6 devices were distributed.
REASON The Tibial Tray labeled as Catalog No. 7376-0005 was laser etched with the wrong Catalog No. 7115-0005.

PRODUCT Cryovalve Allograft (Heart Valve).
CODE Model #PVOO, Serial #6506224.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Colorado.
QUANTITY 1 unit.
REASON Additional information for the organ procurement agency concerning this donor revealed that the donor possessed genital Condylomata (genital warts).

PRODUCT Human Beta-2 Microglobulin Kits, products are in-vitro diagnostic kits and an antiserum:
a) Product Code No. LK043.B, Human Beta-2 Microglobulin Behring Nephelometric Analyzer (BNA) Kit;
b) Product Code No. LK043.BH, Elevated Level Human Beta-2 Microglobulin Enhanced Nephelometric BNA Kit;
c) Product Code No. CUS1303, Human Beta-2 Microglobulin Enhanced Nephelometric BNA Kit;
d) Product Code No. LA043.B, Human Beta-2 Microglobulin Latex Enhanced Antisera BNA;
e) Product Code No. LK043.C, Human Beta-2 Microglobulin Turbidometric Roche Cobas Mira (MIRA) Kit.
CODE Lot Numbers: a) 030349, 034392, EXP 01/00; b) 034393, EXP Jan. 2000; c) 035818, EXP March 2000; 035018, EXP Jan. 2000 d) 035019, EXP Jan. 2000; 035819, EXP Mar. 2000; e) 031386 EXP 01/00.
MANUFACTURER The Binding Site, Ltd., Birmingham, England.
RECALLED BY The Binding Site, Inc., San Diego, California
DISTRIBUTION Alabama, California, Colorado, Florida, Oklahoma, Massachusetts, New Jersey, New York.
QUANTITY 87 kits and 75 vials were distributed.
REASON We are classifying the firm's action as a voluntary recall. We consider the devices to be adulterated in that they may give falsely elevated levels with urine samples.

PRODUCT Architect Free T3 Reagent Kit, a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine(Free T3) in human serum and plasma.
CODE List 6C48-30 (2000 test kit), lot 47106M200; List 6C48-25 (100 test kit), lot 47107M200.
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
DISTRIBUTION Alabama, Florida, Illinois, Kansas, Maryland, Michigan, New Hampshire, New York, Ohio, Pennsylvania, Texas, California, Germany, Japan and Canada.
QUANTITY 247 kits were distributed.
REASON Low recovery when used with multi-constituent controls.

PRODUCT KaVo Intrasept 905, INTRAsurg 500 Dental Operative Unit, an AC powered drilling device intended to supply power to and serve as a base for other dental devices such as a dental handpiece during dental and maxillofacial surgery.
CODE Serial numbers: 824-828, 830, and 831.
MANUFACTURER KAVO DENTAL GmBH, Biberach-Riss, Germany.
RECALLED BY The Straumann Co., Waltham, Massachusetts
DISTRIBUTION Arizona, California, Delaware, Massachusetts, Montana, Texas.
QUANTITY 7 units were distributed.
REASON Software defect may cause the unit to shutdown prior to reaching the preset torque limit.

PRODUCT Apligraf (Graftskin), indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficiency of greater than 1-month duration which has not responded to conventioanl therapy.
CODE Lot Numbers: GS9906.22.03.1A and GS9906.22.03.2A EXP 7/23/99.
MANUFACTURER Organogenesis, Inc., Canton, Massachusetts.
DISTRIBUTION Alabama, Arizona, California, Georgia, Illinois, Indiana, New York, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Texas.
QUANTITY 58 units were distributed.
REASON The pH was found to be out of specification range.