APRIL 2000

WEEK ENDING APRIL 14

PRODUCT LIFEPAK 500 Automated External Defibrillator (AED), designed to be used by first responders to cardiac emergencies.
CODE All serial numbers with more than 8 digits. All serial numbers with 6 digits. 7 digit serial numbers less than 7925937 and serial number 8631084.
MANUFACTURER Medtronic Physio-Control Corporation, Redmond, Washington.
DISTRIBUTION Nationwide and international.
QUANTITY 8,031 units were distributed.
REASON Potential damage/failure of resistor R4 could result in unusable unit next use.

PRODUCT Irrigation Administration Sets, used to provide irrigating solution to the surgical field as well as other various uses: a) BSS and BSS Plus Sterile Irrigation Solution Administration Set, Catalog No. (REF) 0065-0826-50, including Custom Paks; b) Vitrectomy Surgery Set (MVS), Catalog No. 8065807101.
CODE Stand alone BSS/+ Administration Set: 105517H, 107061H, 108101H, 109106H, 109175H, 111592H, 111630H, 115025H, 117113H, 118023H, 118980H, 120465H, 121766H, 122469H, 122485H, 124890H,
Vitrectomy Surgery Set: 124885H
Custom Pak: 115480H, 116288H, 116363H, 116498H, 116572H, 116670H, 116726H, 116895H, 117183H, 117235H, 117391H, 117433H, 117446H, 117451H, 117511H, 117533H, 117597H, 117614H, 117642H, 117644H, 117710H, 117758H, 117834H, 117874H, 117909H, 117910H, 117969H, 117974H, 117975H, 117979H, 118164H, 118230H, 118278H, 118284H, 118346H, 118365H, 118449H, 118508H, 118584H, 118650H, 118815H, 118917H, 119015H, 119017H, 119025H, 119120H, 119121H, 119150H, 119208H, 119282H, 119547H, 119581H, 119650H, 119928H, 120210H, 120235H, 120291H, 120351H, 120362H, 120428H, 120437H, 120439H, 120573H, 120610H, 120643H, 120647H, 120696H, 120704H, 120786H, 120805H, 120822H, 120877H, 120919H, 120967H, 121005H, 121073H, 121165H, 121282H, 121338H, 121348H, 121421H, 121423H, 121429H, 121447H, 121534H, 121654H, 121843H, 121892H, 121899H, 121914H, 122042H, 122377H, 122426H, 122466H, 122694H, 122696H, 122740H, 122854H, 122931H, 122966H, 123192H, 123322H, 123323H, 125391H, 123536H, 123537H, 123608H, 123686H, 123719H, 123840H, 123918H, 123979H, 124183H, 124185H, 124187H, 124377H, 124546H, 124554H, 124606H, 124758H, 124832H, 125006H, 125098H, 125116H, 125118H, 125122H, 125169H, 125181H, 125262H, 125320H, 125323H, 125380H, 125422H, 125522H, 125606H, 125660H, 125841H, 125939H, 125941H, 126003H, 126226H, 126533H, 126577H, 126873H, 127752H, 128158H, 125206H, 128236H, 128364H, 12B365H, 128370H, 128371H, 128380H, 128420H, 128483H, 128485H, 128522H, 128984H, 129398H, 129564H, 131137H, 131138H, 131392H, P124225H, P122487H, P128488H, P125437H, P121813H, P121812H, P113740H, P121811H, P121787H, P123387H, P127721H, P132051H.
MANUFACTURER Alcon Laboratories, Inc., Fort Worth, Texas.
DISTRIBUTION Nationwide and international.
QUANTITY 33,825 units were distributed from 9/00 to 1/00.
REASON An unauthorized change in the filter paper of the filtered-drip chamber that caused the device to have a decreased flow rate.

PRODUCT Model No. 250 NeuroCybernetic Prosthesis Programming (NCP) Software, Version 5.0 for use only with the Model No. 100 NCP Pulse Generator and Model No. 200 NCP Programming Wand, an implanted autonomic nerve stimulator implanted for epilepsy.
CODE All lots.
MANUFACTURER Cyberonics, Inc., Houston, Texas.
DISTRIBUTION Nationwide, South Africa, Belgium.
QUANTITY 402 units were distributed; firm estimates none remains on the market.
REASON The software contains a flaw that reports an inaccurate amount of remaining battery life for the pulse generator.

PRODUCT Cofield 2 Humeral Stem, 12 mm Diameter Stem 145 mm Length, Catalog #71259012, in sterile packages, for use by an orthopedic surgeon in the treatment of proximal humerus fractures.
CODE Lot numbers: 81102601 - 81102610.
MANUFACTURER Smith and Nephew, Inc., Orthopaedic Division, Memphis, Tennessee.
DISTRIBUTION Nationwide, France, Australia, and United Kingdom.
QUANTITY 97 units were distributed; firm estimated that 75 units remained on market at time of recall initiation.
REASON The device does not have suture holes in the lateral fin.

PRODUCT ALYCON Sample Syringe, 50uL used on Alcyon Analyzers 300 and 300i, for in vitro diagnostic tests.
CODE List Numbers 05D049-02 software used on ALCYON Analyzer List Numbers 04D66-02; 04D67-02; 04D68-02; 04D69-02; 0467-03; 04D69-03.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Irving, Texas.
DISTRIBUTION Nationwide and Hong Kong.
QUANTITY 22 units were distributed.
REASON Packages labeled and distributed as containing ALYCON Sample Syringe, 50uL contained ALYCON Reagent Syringe, 500uL instead.

PRODUCT Roche Reagent for AST [aspartate aminotransferace], in vitro diagnostic reagent system for use on the COBAS MIRA and COBAS FARA chemistry systems for the quantitative determination of the AST.
CODE Catalog #42381. Lot Numbers: 60642601 EXP 8/00 and 60770501 EXP 11/00.
MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana (Distributor).
DISTRIBUTION Nationwide
QUANTITY Approximately 6,000 kits were distributed.
REASON Lots do not meet the stability claim for the working reagent.

PRODUCT Total Bilirubin Reagent, Catalog #0737488, for use on the cobas integra 400 and 700 chemistry systems for the quantitative determination of the total bilirubin concentration in blood and plasma
CODE Lot #603976-01 EXP 10/00.
MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY 1,500 kits.
REASON Inadequate filling of R1 reagent may cause reporting of falsely lowered total Bilirubin results without warning of incorrect values.

PRODUCT SETpoint T Uptake Reference Set for Bayer Immuno 1 System, Catalog #T03-3076-01, a T-Uptake calibrator.
CODE Lot Numbers: V35454, V37951, V39825.
MANUFACTURER Bayer Corporation, Business Group Diagnostics, Middletown Manufacturing Plant, Middletown, Virginia. (NOTE: The Middletown plant has since been sold to Fisher Scientific, Inc. [January 2000] and Fisher will be an OM contractor for this product).
RECALLED BY Bayer Corporation, Business Group Diagnostics, Elkhart, Indiana
DISTRIBUTION Nationwide, Belgium, Canada, France, Germany, Sweden and Switzerland.
QUANTITY 758 kits were distributed.
REASON Product found to be unstable when shipped or stored per label instructions.

WEEK ENDING APRIL 21

PRODUCT Custom Procedure Based Delivery Systems Surgical Kits packaged to specifications form the customers, and containing recalled Techni-Care Surgical Prep.
CODE
Catalog No. PBOCDCTMP; Catalog No. PDOCLSTMP; Catalog No. PBOCPETMM; Catalog No. PBOCHYTMP;
Catalog No. PBOCLSTMQ; Catalog No. PBOCPETMN; Catalog No. PBOCHYTMR; Catalog No. PBOCLVTMS;
Catalog No. PL41VDPRG.
MANUFACTURER Allegiance Healthcare Corp., McGaw Park, Illinois
COMPONENT MANUFACTURER Care-Tech Laboratories, Inc., Division of Consolidated Chemical, Inc., St. Louis, Missouri.
DISTRIBUTION Connecticut, Texas.
QUANTITY 1,104 kits were distributed.
REASON Techni-Care Surgical Prep solution in the kits is contaminated with Pseudomonas aeruginosa bacteria.

PRODUCT Allograft Heart Valve, Model Numbers - AV05, PV05, AV00, PV00.
CODE Serial Numbers: 3929116, 3929124, 6026427, 6026435.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Kansas, Michigan, Germany, Japan.
QUANTITY 4 valves.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT IMMUNOCARD MYCOPLASMA, an ELISA diagnostic test kit for detection of IgM to Mycoplasma pneumoniae in human serum.
CODE Catalog #709030, Lot Numbers: 709030.091 through 709030.094; and 709030.097 through 709030.102.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 3,694 units were distributed.
REASON Test results and control results exhibit a high level of variability.

PRODUCT Allograft Heart Valve, Model Numbers PV00 and AV00.
CODE Serial numbers: 3877868, 3918009, 3918017.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Michigan and Canada.
QUANTITY 3 valves.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT Venturi Ventilators Part #1572
CODE Ventilators manufactured and distributed between June 24, 1997 and February 23, 2000.
MANUFACTURER Cardiopulmonary Corporation, Milford, Connecticut.
DISTRIBUTION Connecticut, Florida, New Jersey, North Carolina, South Carolina, Italy, United Kingdom, Saudi Arabia, France, Mexico.
QUANTITY 109 units.
REASON During extended use of the humidifier and the airway heater, the breathing bag may become soft and pliable. This condition when combined with high-pressure settings may allow the breathing bag to intermittently impede expiratory flow and lead to an interruption in exhalation and higher than expected airway pressures.

PRODUCT First Aid kits containing recalled Clinipad products:
a) Blister Kit containing, in part, 5 sterile alcohol prep pads
b) Pocket First Aid Kit containing, in part, 4 sterile alcohol prep pads
c) Weekend Warrior First Aid Kit containing, in part, 3 sterile alcohol prep pads
d) Cramer Personal First Aid Kit containing, in part, 6 sterile alcohol prep pads
e) Retail First Aid Kit containing, in part, 15 sterile alcohol prep pads.
CODE
a) Blister Kit - No lot number
b) Pocket First Aid Kit - LKE169, LKK391
c) Weekend Warrior First Aid Kit - LKK400
d) Cramer Personal First Aid Kit - LKB061, LKC111, LKD112, LKG250, LKH308, LKK397
e) Retail First Aid Kit - LKC102, LKE160, LKF180, LKI313, LKK382.
MANUFACTURER Cramer Products, Inc., Gardner, Kansas.
DISTRIBUTION Nationwide.
QUANTITY a) Blister Kits - 1,152; b) Pocket First Aid Kits - 1,217; c) Weekend Warrior First Aid Kits - 100; d) Cramer Personal First Aid Kits - 5,315; e) Retail First Aid Kits - 4,444.
REASON First aid kits contain Clinipad Alcohol Prep Pads labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Boston Scientific Scimed Wiseguide MP HS 8 French Guide Catheters (Coronary Guiding Catheters), Catalog number 16320-41, designed to provide a pathway through which a medical instrument, such as a balloon catheter for treating coronary arteries, can be delivered.
CODE Lot #3005354.
MANUFACTURER Scimed Life Systems, Inc., Boston Scientific Corporation, Maple Grove, Minnesota.
DISTRIBUTION Arizona, Colorado, South Carolina.
QUANTITY 3 catheters were distributed.
REASON The curved distal portion of the catheters could crack and break loose from the catheter shaft.

PRODUCT Heart Valve Allograft, Model AV00.
CODE Serial #3905802.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Illinois.
QUANTITY 1 valve.
REASON Donor did not meet current guidelines regarding serodilution of plasma.

PRODUCT Heart Valve Allograft, Model PV00.
CODE Serial #6684073.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Illinois.
QUANTITY 1 valve.
REASON Donor was unsuitable for allograft donation due to excessive plasma dilution at time serological samples were collected for testing.

PRODUCT Heart Valve Allograft, Model PV00 and AV00.
CODE Serial Numbers: 3905829, 6084338, 6084346, 6197469, 6197477, 6214975, 6214983
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Kentucky, Minnesota, Colorado, Florida, Tennessee.
QUANTITY 7 valves.
REASON Donor did not meet current guidelines regarding serodilution of plasma.

PRODUCT MINICAP XP Workstations, using Baseline 8.5 software, for Computed Tomography SPECT studies with gamma cameras.
CODE All Marconi MINICAP XP workstations using the Baseline 8.5 software.
MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 131 units were distributed.
REASON During 360 degree SPECT, the resulting image will appear flipped left to right.

PRODUCT Heat Condenser Humidifier, Catalog No. 1571.
CODE Lot Numbers: 2-44910, 2-45910, 4-47910, 1-48910, 3-44910, 3-45910, 5-47910, 1-49910, 2-50910, 4-51910, 2-52910,3-49910, 3-50910, 3-52910, 4-49910, 6-49910.
MANUFACTURER Hudson Respiratory Care, Inc., Temecula, California.
DISTRIBUTION Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Canada, Japan, Thailand.
QUANTITY 70,405 units were distributed.
REASON The product contains a chemical odor that could compromise a patient during the device's initial use.

PRODUCT Sterile Procedure Kits/Trays containing recalled Clinipad products
CODE
i) Central Line Tray, catalog #470, lots 668, 669
ii) Dressing Change Tray, catalog #478, lots 668, 669
iii) Subclavian Dressing Change Tray, catalog #755, lot 669
iv) Hyperal Tray, catalog #580A, lots 667, 669
v) Cambridge Marketing I.V. Start Kit, catalog # SW4000, lot 667
vi) Subclavian Tray, catalog #359, lot 663
MANUFACTURER Sterling Medical-Products International, Inc., Prophetstown, Illinois.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Illinois, South Carolina, Tennessee.
QUANTITY 2,280 kits.
REASON The kits and trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility.

PRODUCT Medline Sterile Procedure Kits/Trays containing recalled Clinipad Products.
CODE
Kit Catalog # Kit Description
DMCHLDCT0 Central Line Dressing Change Tray
DMGTPN01 TPN Tray
DMHHCLDCT0 Central Line Dressing Change Tray
DMHVPICC01 Fill Dressing Tray
DYNDC1001 Central Line Dressing Change Tray
DYNDC1002 Dressing Change Tray
DYNDC1003 Central Line Dressing Tray
DYNDC1005 Dressing Change Tray
DYNDC1007 Dressing Change Tray
DYNDC1009 Central Line Dressing Change Tray
DYNDM1002 TPN Tray
DYND74560 Central Line Dressing Change Tray
DYND74561 Dressing Change Tray - Tegaderm
DYND74562 Dressing Change Tray - Sureste
DYND74565 Central Line Dressing Change Tray
DYND74566 Dressing Change Tray - Tegaderm
DYND30210 Midstream w/Funnel/PVP, 4oz Cup
DYND30226 Midstream w/PVP, 4oz ECO
DYNJ07141C Subclavian Tray
DYNDM1004 Fistula Pack
DYND12110 Cath Care Tray
DYND20100 Sterile Irrigation Tray
DYND20105 Sterile Bulb Irrigation Tray
DYND20300 Sterile Irrigation Tray
DYND20305 Irrigation Tray
DYND70900 Suture Removal Tray
DYND71030 Suture Removal Tray
DYND74000 IV Start Kit
DYND74003 IV Start Kit
DYND74015 IV Start Kit
DYND74053 IV Start Kit
DYND74081 IV Start Kit
DYND74100 Subclavian On Pack
DYND74101 Subclavian Off Pack
DYND74102 Fistula Pack
DYND74226G On/Off Kit
DYND74601 Blood Withdrawal Tray
DYNJC2047D Port Starter Kit
DYNJC2741 HYP Subclavian Dressing Tray
DYNJC2777 Dressing Removal Tray
DYNJ04000A IV Start Kit Flexigrid
DYNJ04001 IV Start Kit
DYNJ04014C IV Start Kit
DYNJ04060 Skin Staple Removal Kit
DYNJ04060 Skin Staple Removal Kit
DYNJ04081 IV Start Kit
DYNJ04156 IV Start Kit
DYNJ04205A IV Start Kit
DYNJ04208A IV Start Kit
DYND04216 On/Off Tray
DYNJ04242A Suture Removal Tray
DYNJ04244 IV Start Kit
DYNJ05611 IV Start Kit
DYNJ05712B IV Start Kit
DYNJ05877A IV Start Kit
DYNJ07147 Incision & Drainage Tray
DYNJ07179A Suture Removal Kit
DYNJ07267B Subclavian Dressing Tray
DYNJ07293 Wound Closure
DYNJ07450 Dialysis Tray
DYNJ15384 Suture Removal Tray
MDS701550 Suture Removal Tray
MDS706551 Suture Removal Tray
MDS70815 Incision & Drainage Tray
MDS708550 Suture Removal Tray
Note 1: Home Care kits will be the same part numbers as listed above except there is an "H" suffix.
Note 2: Single packs will be the same part numbers as listed above except there is a "Z" suffix.
MANUFACTURER Medline Industries, Inc., Mundelein, Illinois.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY Approximately 230,000 kits.
REASON Kits and trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility.

PRODUCT Sterile Catheter Irrigation Trays and Wound Dressing Trays; 20 trays per case containing recalled Clinipad Products:
a) Visiting Health Professionals Catheter Irrigation Tray, Premium Custom Concepts, a Division of Premium Plastics, Inc., Chicago, IL 60616; reorder #3022016
b) Unicare Deluxe Facial Wound Closure Instrument Pack, reorder #2663
c) Unicare Wound Closure Tray, reorder #2665
CODE a)Lots PE0038 and PG0063; b) Lot RF0020; c) Lots RF0025 and SH2156.
MANUFACTURER Premium Plastics, Inc., Chicago, Illinois.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION North Carolina and Puerto Rico.
QUANTITY 5,820 trays.
REASON Kits and trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility.

PRODUCT On/Off dialysis kits containing recalled Clinipad products as follows:
a) MPC-595; b) MPC-590; c) MPC-685.
CODE
a) MPC-595 - Lot #804917, 900975, 902649, 6L786, and 916129
b) MPC-590 - Lot #97G10B, 802258, 817819, 910665, VA0625, and AK982
c) MPC-685 - Lot #712084, 716073, 805046, 900984, and 914327
MANUFACTURER Molded Products, Harlan, Iowa.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Wisconsin and California.
QUANTITY MPC-590 - 6,550 kits; MPC-595 - 3,650 kits; and MPC-685 - 41,450 kits.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Medical PEG kits containing recalled Clinipad products:
Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Pullwire System 15FR, Cat #110115;
Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Pullwire System 20FR, Cat #1101120;
Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Pullwire System 24FR, Cat #1101124;
Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Guidewire System 15FR, Cat #1101215;
Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Guidewire System 20FR, Cat #1102120;
Surgitek Surgi-PEG, Initial Placement Gastrostomy Tray - Guidewire System 24FR, Cat #1102124;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 24FR 1.7cm, Cat #4018170;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 24FR 2.4cm, Cat #4018240;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 24FR 3.4cm, Cat #4018340;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 24FR 4.4cm, Cat #4018440;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 1.2cm, Cat #4118120;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 1.7cm, Cat #4118170;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 2.4cm, Cat #4118240;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device - Guidewire Method 18FR 3.4cm, Cat #4118340;
Surgitek S.O.S., One-Step Button with Percutaneous Stoma Measuring Device Guidewire Method 18FR 4.4cm, Cat #4118440;
Percutaneous Stoma Measuring Device - Guidewire, Cat #PSMD-GW;
Percutaneous Stoma Measuring Device - Pullwire, Cat #PSMD-PW.
CODE A total of 68 lot numbers are as follows:
97070353, 97070713, 97070714, 97070863, 97090709, 97070066, 97080305, 97080615, 97100463, 97100464, 97070581, 97080616, 97100471, 97040072, 97080304, 97100010, 97040511, 97040536, 97040787, 97050435, 97090008, 97100229, 97100472, 97110609, 97080303, 97110045, 97080589, 97090043, 97100486, 97070704, 97080069, 97080285, 97080597, 97090021, 97090882, 97100489, 97100631, 97050675, 97050901, 97070566, 97070702, 97080068, 97080289, 97080587, 97080592, 97080863, 97090041, 97090459, 97080288, 97080595, 97090039, 97090458, 97090702, 97100642, 97110603, 97080287, 97080596, 97090681, 97070570, 97080286, 97090683, 97090700, 97090457, 97090460, 97100112, 97100788, 97100804, and 97100787.
MANUFACTURER Applied Medical Technology, Inc., Cleveland, Ohio.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Wisconsin.
QUANTITY 1,982 kits were distributed.
REASON Kits contain Clinipad products labeled as sterile, for which Clinipad cannot assure the sterility.

PRODUCT Custom Procedure Ready Trays containing recalled Clinipad Products:
1) Part No. 16-01029, Custom Angio Card Cath Pack
2) Part No. 16-02130, Custom Adult Cardiac Cath Tray
3) Part No. 16-02355, Custom Cardiac Cath Lab Pack
4) Part No. 16-02451, Custom Angio Card Cath Pack
5) Part No. 18-02510, Custom Biopsy Tray
CODE
1) Lots MFG5994, MFG5955, MFG6086, MFG6098
2) Lots MFG5921, MFG6157
3) Lot MFG5978
4) Lot MFG6051
5) Lots MFG5848, MFG5917, MFG5927, MFG5937.
MANUFACTURER Medical Techniques, In., North Salt Lake, Utah.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION New Jersey, Texas, Saudi Arabia.
QUANTITY 450 trays were distributed.
REASON The trays contained Clinipad products that lacked assurance of sterility.

PRODUCT First Aid Kits containing Clinipad Product:
Model Numbers: 11000 12318 12600 12702 12703 12704 12988 12989 13300 13126 14302 14303 25001 26000 30500 33000 38000 40001 50000 51019 60002 60003.
CODE Lot Numbers: 299135, 299139, 299162, 299329, 299385, 299077, 299143, 299075, 298693, 299131, 299176, 299177, 299382, 299249, 299275, 299092, 299258, 299271, 299136, 299188, 299213, 299116, 299186, 299187, 299289, 299261, 299286, 298685, 299091, 299130, 299178, 299191, 299248, 299278, 299292, 299193, 299129, 299179, 299220, 299268, 299041, 299104, 299148, 299321, 299064, 299194, 299203, 299244, 299282, 298702, 299114, 299245, 299269, 299190, 299256, 299352, 298650, 298683, 298698, 298710, 299034, 299105, 299158, 299209, 299274, 298668, 299093, 299227, 299285, 299293, 299100, 299113, 299257, 299279, 299294, AND 299322.
MANUFACTURER Acme United Corp., Fremont, North Carolina.
RECALLED BY Acme United Corporation, Fairfield, Connecticut
COMPONENT MANUFACTURER Clinipad Corporation, Charlotte, North Carolina.
DISTRIBUTION Nationwide.
QUANTITY 2,228,697 products were repackaged into kits of 22 different configurations (models).
REASON The kits contain Clinipad Alcohol Prep which have been recalled by the Clinipad Corporation for possible microbiological contamination.

PRODUCT  Total B-hCG, for in vitro diagnostic use.
CODE List no.9C21-10,
Lot # 57210Q100, EXP date 4/5/00
Lot # 59236Q100, EXP date 6/1/00.
MANUFACTURER Abbott Health Products, Inc., Barceltoneta, Puerto Rico.
DISTRIBUTION Nationwide and international.
QUANTITY 5,412 units were distributed.
REASON Control values are greater than the package insert ranges.

PRODUCT CSI Daily Wear Clear Contact Lenses.
CODE Sub lot # 700022570404 Master lot #60300195.
MANUFACTURER Wesley Jessen Corporation, Cidra, Puerto Rico.
DISTRIBUTION California, Illinois, Maryland, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Virginia.
QUANTITY 27 lenses were distributed.
REASON Mislabeled for corrective power. The label indicates sphere power of +8.00. The lenses are actually -20.00.

PRODUCT Series II Compact Video Imager Multi Format Camera; used with gamma cameras, nuclear, C-Arm, and digital radiography.
CODE Model MP4600-2A-X, serial numbers 3162B, 3163B, 3164B.
MANUFACTURER International Imaging Electronics, Bolingbrook, Illinois.
DISTRIBUTION California.
QUANTITY 3 units were distributed.
REASON The video imagers had been shipped without final testing and final inspection.

PRODUCT Circon Surgitek Double J Silicone Ureteral Stents, Part Numbers 5202100 and 5202600, can be used to provide drainage from the kidneys to the bladder, and stenting of the ureter without external catheters.
CODE Product number 5202100, lots 631289H and 631299H Product number 5202600, lot 633359H.
MANUFACTURER Circon Surgitek, Racine, Wisconsin.
DISTRIBUTION Nationwide, Austria, Canada, France, Ireland, The Netherlands.
QUANTITY 360 stents.
REASON Inner diameters of stents are too small to allow passage of guidewires.

WEEK ENDING APRIL 28

PRODUCT ProCide NS Reusable Activated Dialdehyde Sterilizing and Disinfecting Solution, in 2.5-gallon, 1-gallon and 1-quart units, a re-usable activated dialdehyde sterilizing and disinfecting solution.
CODE All lots. Expiration dates range from September 2000 through December 2001.
MANUFACTURER Metrex Research Corporation, Parker, Colorado.
RECALLED BY Sybron Dental Specialties, Inc., Orange, California
DISTRIBUTION Nationwide.
QUANTITY 2,057 cases (1-quart size), 143,409 (1-gallon size), and 356 cases (2.5-gallon size) were distributed.
REASON Failure of the product to achieve sterilization or high level disinfection may result in patients being exposed to the risk of infection.

PRODUCT Rascal and Chauffeur Heavy Duty Scooters:
a) Rascal and Chauffeur Heavy Duty 3-Wheel Scooters (Models 205,235, and 245);
b) Rascal and Chauffeur Heavy Duty Indoor 4-Wheel Scooters (Models 255 and 275);
c) Rascal and Chauffeur Heavy Duty Outdoor 4-Wheel Scooters (Models 215, 305, and 315).
CODE The prefixes to the serial numbers affected by the recall are: UR; RO; RU; RUF; RUU; RDEM; CVU
MANUFACTURER Electric Mobility Corporation, Sewell, New Jersey.
DISTRIBUTION Nationwide and international.
QUANTITY 10,778 scooters were affected.
REASON The drive train gears fail (sheer) allowing the scooters to coast (free-wheel) without control for stopping.

PRODUCT Pacesetter Trilogy Pulse Generator, indicated for the treatment of bradycardia:
a) Trilogy(tm) SR 2250L Pulse Generator;
b) Trilogy(r)SR+ 2260L Pulse Generator;
c) Trilogy(r) SR+ 2264L Pulse Generator;
d) Trilogy(tm) DC 2308L Pulse Generator;
e) Trilogy(r) DC+ 2318L Pulse Generator;
f) Trilogy(tm) DR 2350L Pulse Generator;
g) Trilogy(tm) DR+ 2360L Pulse Generator;
h) Trilogy(tm) DR+ 2364L Pulse Generator.
CODE
2250 ALL SERIAL NOS 2260 ALL SERIAL NOS. EXCEPT 184500 THRU 223346
2264 ALL SERIAL NOS. EXCEPT 182800 THRU 196114
2308 ALL SERIAL NOS.
2318 ALL SERIAL NOS. EXCEPT 184500 THRU 202821
2350 ALL SERIAL NOS.
2360 ALL SERIAL NOS. EXCEPT 194956 THRU 200821
2364 ALL SERIAL NOS. EXCEPT 212662 THRU 213771; 214271 THRU 215421; 216422 THRU 217346; 217847 THRU 218946; 219222 THRU 219721; AND, 219947 THRU 220545 AND 50000-159000.
MANUFACTURER St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 163,000 affected pulse generators have been implanted since their introduction to commerce in 1995, the firm states that there are about 3200 affected devices in field inventories.
REASON The devices may exhibit premature battery depletion caused by a current leakage path that could be created during the laser welding process to attach the battery to the device hybrid.

PRODUCT Pacesetter Affinity Dual Chamber Pulse Generators, also known as cardiac pacemaker:
a) Model No. 5130L; b) Model No. 5130R; c) Model No. 5230R; d) Model No. 5330R; e) Model No. 5330L.
CODE Affected products all have a "use before" date of December 2000. They were produced in June 1999.
MANUFACTURER St. Jude, Inc., Cardiac Rhythm Management Division, Sylmar, California.
DISTRIBUTION Nationwide, Canada, Sweden.
QUANTITY 850 were implanted 41 have been explanted plus 18 non-implanted units were returned.
REASON Decreased reliability has been observed in a limited, very specific, and well-defined group of Affinity pulse generators. Testing has revealed that conductive material used to secure a resistor to the hybrid circuitry may not provide continuous and proper electrical connection to the underlying circuitry. This resistor is used to measure the battery operating current of the pulse generator and is reported to the clinician through the programmer. The battery itself is not affected.

PRODUCT Outbound Disposable Syringe Infuser and Kits, indiated for intravenous, intra-arterial and subcutaneous delivery of antibiotics, analgesics, or chemotherapeutic agents and other medication or fluids requiring continuous delivery at controlled infusion rates:
a) Outbound Disposable Syringe Infuser, Sterile, Catalog No. OB1N00;
b) Outbound Surgical Application Continuous Postoperative Pain Control System, Catalog No. 500-120;
c) Stryker Pain Pump Disposable Syringe Infuser Surgical Application, Catalog No. 500-110.
CODE Catalog Numbers: OB1N00 (infuser) 500-120 (kit) 500-110 (kit)
Infuser Lot Numbers: D990322-H, D990324-D, D990326-A, D990412-B, D990412-F, D990415-B, D990419-B, D990419-E, D990422-G, D990426-A, D990426-B, D990426-F, D990427-A, and D990428-E.
MANUFACTURER McKinley Medical LLLP, Wheat Ridge, Colorado.
DISTRIBUTION California, Colorado, Florida, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, Nevada, Oklahoma, Tennessee, Texas, Washington state, and Italy
QUANTITY 24,174 infusers.
REASON The pumps would not infuse, prime, or experienced backflow.

PRODUCT Sarns 8K Safety Monitor and 9K Perfusion System, indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures:
a) 8000 Perfusion System Safety Monitor, Part No. 98-0702-06606;
b) Reconditioned 8K Safety Monitor, Part No. 78-8067-7278-2;
c) Trial 8K Safety Monitor, Part No. 78-8067-6878-0;
d) Loaner 8K Safety Monitor, Part No. 78-8067-6053-0;
e) 9000 Perfusion System 110V, Part No. 98-0702-0270-4;
f) 9000 Perfusion System 220V, Part No. 98-0702-0269-6;
g) 9000 Perfusion System 100V, Part No. 98-0702-0268-8;
h) Reconditioned 9K Perfusion System, Part No. 78-8066-6922-8;
i) Trial 9K Perfusion System, Part No. 78-8066-8934-1.
CODE See above.
MANUFACTURER Terumo Cardiovascular Systems Corporation, Ann Arbor, Michigan.
DISTRIBUTION Nationwide and international.
QUANTITY 1,688 units were distributed.
REASON The level sensor system malfunctions. The malfunctions have been related to false alarms when there was an adequate fluid level in the reservoir and failure to alarm when the blood level fell below the position of the sensor.

PRODUCT Puritan-Bennett Reusable Coupling Temperature Probe, component of the Reusable Volume Ventilator Circuits:
a) Reusable Coupling Temperature Probe (Coupler), Catalog No. 4-007897-00;
b) Patient Tubing Circuit with Nebulizer, Catalog No. 4-018062-00;
c) Simplified Circuit with Vial, Catalog No. 4-018744-00;
d) Simplified Circuit without Collector Vial and Adapter, Catalog No. 4-020740-00;
e) Simplified Circuit with Traps, Catalog No. 4-015254-00;
f) Simplified Circuit with Nebulizer, Catalog No. 4-018052-00;
g) Simplified Patient Circuit, Catalog No. 4-018011-00;
h) Patient Tubing Circuit - Conventional, Catalog No. 4-019348-00;
i) Simplified Patient Circuit, Catalog No. 4-007170-00;
ii) Simplified Circuit w/o Vial, Catalog No. 4-018743-00.
CODE All product with lot numbers K00902 or lower, and all lots with a numeric lot number only (no letter "K" prefix).
MANUFACTURER Avenida Reforma S/N, Local A-3, Tijuana B.C., Mexico.
RECALLED BY Puritan Bennett Corporation, a subsidiary of Mallinckrodt, Inc., Carlsbad, California
DISTRIBUTION Nationwide and international.
QUANTITY 4,381 couplers domestically, and 8,170 couplers internationally were distributed.
REASON The flashing in the area of the temperature probe port was not removed.

PRODUCT Percutaneous Catheter Introducer Kits containing recalled Clinipad products.
CODE Abbott Kits:
Part #KIT-015-00 Lots F53699 and F40968
Part #KIT-016-00 Lot F40958
Becton Dickinson Kits:
Part #KIT-012-00 Lot F52529
Part #KIT-009-01 Lot F51169
Part #KIT-010-00 Lot F51209
Part #KIT-012-01 Lot F52539
Part #KIT-009-00 Lot F51159.
MANUFACTURER Thomas Medical Products, Inc., Malvern, Pennsylvania.
COMPONENT MANUFACTURER Clinipad Corporation, Charlotte, North Carolina.
DISTRIBUTION California and Utah
QUANTITY 3,090 kits.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Trinity IV Start Kits containing recalled Clinipad Products.
CODE Item #1067-01-03-R1, Lot Numbers: 99236, 99247, 99248.
MANUFACTURER Trinity Laboratories, Inc., Salisbury, Maryland.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION New York.
QUANTITY 432 cases (50 pads per case) were distributed.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.