JULY 2000

WEEK ENDING JULY 7

PRODUCT Various kits/trays containing containing products recalled by Clinipad Corporation: Peripherally Inserted Central Catheter; MLC SLI Peripherally Inserted Central; PAT 100 Port Access Tray; CISK B. Braun IV Start Kits; CGKM Guidewire Introducer Set; CESKSD Continuous Epidural Anesthesia Tray; Spinocan Spinal Needle; Braun Percutaneous Introducer Set; Burron Microcath Intra. Cath. Placement; Runyon Large Volume Parcentesis Kit; Double Ended Vented Transfer Device; Dressing Change Tray; Dressing Change Kits.
CODE (Note: If necessary, A complete list of devices, catalog and lot numbers can be obtained from the Philadelphia District Office Recall Coordinator).
MANUFACTURER B. Braun Medical, Inc., Allentown, Pennsylvania.
COMPONENT MANUFACTURER Clinipad Corporation, Charlotte, North Carolina.
DISTRIBUTION Nationwide.
QUANTITY 921,000 units.
REASON The products contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility and/or contain Clinipad products not labeled as sterile for which the company has no assurance that they meet microbiological release specifications.

PRODUCT Valleylab LS1000 Ligasure Vessel Sealing System, for use in general and plastic surgery.
CODE Lot Numbers: ANH000330, ANH000404, ANH000407, ANH000410 thru ANH000414, ANH000417 thru ANH000420.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
DISTRIBUTION Alabama, Arizona, California, Colorado, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Wyoming, Australia, Canada, France, Israel and Lebanon.
QUANTITY 155 cases, 6 units per case were distributed.
REASON Grasping ability of device may decrease and, with continued use, come apart.

PRODUCT Bayer Advia 120 Automated Hemotology System, Model 120, a quantitative automated hematology analyzer that provides a leukocyte, differential count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories.
CODE All serial numbers.
MANUFACTURER Bayer Diagnostics Mfg. Ltd., Swords, Co. Dublin, Ireland.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUTION Nationwide and international.
QUANTITY 1,800 units were distributed.
REASON Higher than expected percentage Reticulocyte counts were received, due to carryover from one sample to another.

PRODUCT CyroValve Allograft Heart Valves.
CODE
Serial No. - 3975614 - Model No. PV05,
Serial No. - 3979504 - Model No. AV00,
Serial No. - 3979512 - Model No. PV00,
Serial No. - 6160301 - Model No. AV00,
Serial No. - 6160328 - Model No. PV00.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Utah, Florida, Michigan, Minnesota.
QUANTITY 5 valves were distributed.
REASON Donor did not meet current guidelines for serodilution of plasma.

PRODUCT CyroValve Heart Valve Allograft.
CODE Serial No. 4302801 - Model No. PV00.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION California.
QUANTITY 1 valve was distributed.
REASON Allograft was collected from a donor who had been incarcerated.

PRODUCT Howmedica Ostenonics System 12 Crossfire P4 10 polyethylene insert, Catalog number 6352-5-074.
CODE Case Code TC3021.
MANUFACTURER Howmedica Ostenonics Corp., Allendale, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 151 units were distributed.
REASON Size improperly stamped.

PRODUCT The Becton Dickinson (Bard Parker) ABG Kits, containing recalled Clinipad products.
CODE Catalog Numbers 305089, 375280, 305306, 375310, 375315, 375320, 375325, 305326, 305342, 375381, 375385, 375392, 375395, 375410, 375420, 305421. (A complete list of devices, catalog and lot numbers can be obtained from the New Jersey District Office Recall Coordinator).
MANUFACTURER Becton Dickinson & Company, Franklin Lakes, New Jersey.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 956,850 kits were distributed.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Sterile Procedural Trays/Kits packaged by Orion Medical Products, Wheeling, IL; the trays are packaged in cases of 10, 20, or 30 trays each under the Orion, Managed Care, Rusch, Lifenet, ProMed, Grace, Manheim, Starline, and Intermed labels.
CODE All Orion kit lot numbers shipped since 1/1/97 of the listed reorder numbers.
a) Kits containing Alcohol Prep Pads, Medium, Cat. 0110B3
b) Kits containing Iodophor-PVP Povidone-Iodine 10% Swabsticks, cat. 12915-13
c) Kits containing Alcohol Prep Pads, Medium and Iodophor PVP
d) Kits containing Iodophor PVP Povidone Iodine 10% Solution, cat. 3944S-B
e) Kits containing Iodophor PVP Povidone Iodine 10% Swabsticks and Iodophor PVP Povidone Iodine 10% Ointment,
f) Kits containing Alcohol Prep Pads, Medium and Iodophor PVP Povidone Iodine 10% Swabsticks, cat. 0110B3 & 1291S-B. (Note: A complete list of devices, catalog and lot numbers can be obtained from the Chicago District Office Recall Coordinator).
MANUFACTURER Orion Life Systems, Inc., Wheeling, Illinois.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 70,000 cases were distributed.
REASON Kits and trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility.

PRODUCT Abbott Plum XL Series Infusion Pumps, single and triple line infusion pumps utilizing I.V. administration set cassettes.
CODE All serial numbers manufactured prior to 12/1/99 of the following list numbers.
11555-04, Plum XL Infusion Pump 11781-04, Plum XL3 Multi-Line Infusion Pump, 11845-04, Plum XL3 Micro/Macro Multi-Line Infusion Pump, 11846-04, Plum XL Micro/Macro Infusion Pump, 11855-04, Plum XL3 Micro/Macro Multi-Line Infusion Pump, w/Dataport, 11859-04, Plum XL Micro/Macro Infusion Pump w/Dataport.
MANUFACTURER Abbott Laboratories, Morgan Hills, California.
RECALLED BY Abbott Laboratories, Hospital Products Division, Abbott Park, Illinois
DISTRIBUTION Nationwide.
QUANTITY 81,159 pumps were distributed.
REASON Increased number of cassette alarms.

PRODUCT Atwater Carey Ltd. First Aid Kits having the following particular names identifying the uses of the kits: Blister Doc, Pocket Doc, Travel Doc, Cycle Doc, Personal (First Aid), Dayhiker, Backpacker, After The Fall, Walkabout, Family (First Aid), International, Expedition, EMT First Aid, Mountain Rescue, 25 Person, EMT WMI, Sport Pak, Whitewater, Pocket Watertight, Swiftwater Paddler, Wilderness Canoe, Marine Life Pak, Athletes Kit, Athletes Replace Module, Coaches Kit, Coaches Replace Module, Team, American Challenge Team, Team Replace Module, Wound Management Module, First Aid Refill of Antiseptic Towelettes, First Aid Refill - Tincture of Benzoin, Blister Kit, and Marine Waterproof. These kits are labeled as assembled by Wisconsin Pharmacal, Inc., Jackson, WI; Wilderness Medicine Pro 0.5, 1.0, 2.0, and 3.0 First Aid Systems. These first aid kits have the firm name and address of Atwater Carey, Ltd., Salida, CO 81201 on the labels. The following private label first aid kits were included in the recall: Eagle Creek Traveler, Kwik Tek, Safeway 25 Person Refill, Campmor Hiker, Campmor Guide, and Campmor Advanced.
CODE Code Information: There are no lot numbers on the kits. The kits have part numbers, as follows: Atwater Carey Ltd. first aid kits: 153-156, 158-163, 165, 166, 168, 169, 171-173, 175, 177, 177CO, 178, 180-184, 182RM-184RM, 184AC, 208, 217, 220, 221, and 299. Wilderness Medicine Pro first aid kits: 260-263 Eagle Creek Traveler Kits: 268 and 268C Kwik Tek Kit: 277; Safeway 25 Person Refill: 282 Campmor first aid kits: 294-296.
MANUFACTURER WPC Brands/Wisconsin Pharmacal Company, Jackson, Wisconsin.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide, Canada, Belgium.
QUANTITY 219,000 kits were distributed; firm estimated that 70,000 kits remained on market at time of recall initiation.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Medical Graphics Cart, Part #800192, used for diagnostic equipment for checking a patient's pulmonary function, ECG, and other factors.
CODE Carts with "99" stamped in their bases with 8 dots arranged in a circle around the 99 are affected.
MANUFACTURER Medical Graphics Corporation, St. Paul, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 46 carts were distributed.
REASON Base of cart could crack allowing caster to come off and cart to topple over.

PRODUCT Replace/Steri-Oss brand of 4.3 mm Diameter Dental Healing Abutment.
CODE Lot #307893, Part #61027, EXP 2/05.
MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California.
DISTRIBUTION California, Colorado, Connecticut, Florida, Idaho, Indiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Washington state.
QUANTITY 110 units were distributed.
REASON The wrong size, 4.5 mm D x 3 mm H, endosseous dental implant (healing abutment) was placed into the device packaging labeled for a 4.5 mm D x 5 mm H healing abutment.

PRODUCT Anti-Needlestick Devices: a) B100L UltraSafe Needle Guard; b) CT200 UltraSafe Injection System.
CODE Lot Numbers: a) 91601, 926701, 926702, 928701, 928702, 929401, 931902, 931903, 932601, 934301, 934401; b) 927001, 92301, 930801, 930802, 930803, 933401, 933701, 936401, 000401.
MANUFACTURER Noved Medical, Chatsworth, California.
RECALLED BY Safety Syringes, Inc., Carlsbad, California
DISTRIBUTION California.
QUANTITY a) 32,200; b) 27,100 were distributed.
REASON Products were misassembled during production, creating the potential for a needle stick health risk.

PRODUCT Transcutaneous Electrical Nerve Stimulators containing recalled Clinipad Sterile Alcohol Wipes. .
CODE Multiple lot numbers. (Note: If necessary, a complete list of lot numbers can be obtained from the Los Angeles District Office Recall Coordinator).
MANUFACTURER Woodside Biomedical, Inc., Carlsbad, California.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 25,357 units were distributed.
REASON Kits contained Clinipad products, labeled as sterile, which lacked assurance of sterility.

PRODUCT Bard/Vas-Cath, Modified Vas-Cath Catheter Repair Kit, Catalog Number 5586000.
CODE Lot Numbers 22AK1493, 22AK1495, 22LJX028.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
DISTRIBUTION Nationwide, Australia and Canada.
QUANTITY 1,008 units were distributed.
REASON Catheter repair kit connector may detach from repaired catheter extension legs.

PRODUCT a) VA Medical Center, Seattle Cardiac Pack; b) Lawrence Memorial Hospital Pericardiocentesis Pack.
CODE Lot Numbers M0899291, M0999201.
MANUFACTURER Cordis Corporation, Miami, Florida (component manufacturer/responsible firm).
RECALLED BY Maxxim Medical, Inc., (formerly Cordis Medical Products), Asheville, North Carolina
DISTRIBUTION Washington state, Kansas.
QUANTITY a) 27 kits; b) 5 packs were distributed.
REASON Kits/packs contain catheters recalled by Cordis Corporation for possible unexpected fibers.

PRODUCT Sorbic Acid Preserved Saline Solution, in 16-ounce bottles, under the following labels: Fedco, Equate, London Drugs and Life.
CODE Lot Numbers 8J101, EXP 10/00; 9C091, EXP 3/01.
MANUFACTURER Optopics Laboratories Corporation, Fairton, New Jersey.
DISTRIBUTION To direct wholesale accounts.
QUANTITY 10,500 bottles of Lot #8J101; 10,728 bottles of Lot #9C091 were distributed.
REASON Lack of sterility assurance of Sorbic Acid Preserved saline.

PRODUCT Immulite 2000 Rapid TSH L2KRT Kits, a solid-phase, competitive chemilumeninescent enzyme immunometric assay disigned for the detection of thyrotropin (thyroid stimulating hormone, TSH) in human serum and as an aid in the clinical assessment of thyroid status.
CODE Lot Numbers 114, 114A, 115, and 116.
MANUFACTURER Diagnostic Products Corporation, Los Angeles, California.
DISTRIBUTION Arizona, California, Colorado, Georgia, Indiana, Kansas, Massachusetts, Maine, Missouri, New Jersey, New Mexico, New
York, Pennsylvania, Rhode Island, South Carolina, Washington, and international.
QUANTITY 845 units were distributed.
REASON The product can yield falsely elevated test results.

PRODUCT Zimmer NexGen Knee Option Femoral Size D, Right, Catalog 00-5996-0114-02.
CODE Lot # 62813700.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
DISTRIBUTION Nationwide and international.
QUANTITY 77 units were distributed.
REASON The buffing residue was left affixed to the underside of the femoral knee component.

PRODUCT Medtronic Midas Rex Disecting Tool: (a) Medtronic Midas Rex Disecting Tool M-1; (b) Medtronic Midas Rex Disecting Tool
AM-3; (c) Medtronic Midas Rex Disecting Tool S4-350 (d) Medtronic Midas Rex Disecting Tool S8-350.
CODE Lot Numbers: (a) N3640, N4158, N4150, N4231, N4555, N4562; (b) O0645; (c) P0963; (d) O4935.
MANUFACTURER Midas Rex, L.P., Fort Worth, Texas.
DISTRIBUTION Nationwide, Turkey, and Ireland.
QUANTITY 290 units were distributed.
REASON The head of the tool may separate during use.

PRODUCT Binax now Legionella Urinary Antigen Text 22 Kit, for the rapid detection of Legionella pneumophilia seogroup 1 antigen.
CODE Lot #002644B, EXP 14 JUN 01.
MANUFACTURER Binax, Inc., Portland, Maine.
DISTRIBUTION Nationwide and Switzerland.
QUANTITY 99 kits were distributed.
REASON Product has an extended expiration date.

WEEK ENDING JULY 14

PRODUCT Various Surgical Trays and Procedure Kits containing Sterile Skin Preparations recalled by Clinipad Corporation.
CODE Lot Numbers: 715786, 805817, 812873 (Class I). (Note: If necessary, a complete list of catalog and lot numbers can be obtained from the Kansas City District Office.
MANUFACTURER Ni-Med, Division of Oak Medical Industries, L.L.C., Farmington, Missouri.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,000,000 trays/kits were distributed were distributed.
REASON Class I - Products may be contaminated with bacteria.
Class II - Trays/kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits/trays identified as containing Clinipad Sterile Skin Preparations with Lot Numbers 715786, 805817 and 813873 - Class I. Kits/trays identified as not containing the above lot numbers, for which the sterility could not be assured - Class II.

PRODUCT Various Percutaneous Endoscopic Gastronomy Kits containing Clinipad Iodophor PVP Povidone Iodine Antiseptic Swabsticks recalled by Clinipad Corporation.
CODE Lot Numbers: 812873, 800468, 807006, 815959, 900359, 818749, 900559, 900560, 902649, 905001 and 911138.
MANUFACTURER Boston Scientific Corporation, Natick, Massachusetts.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connectitcut.
DISTRIBUTION Nationwide.
QUANTITY 89,303 kits were distributed.
REASON Class I - Products may be contaminated with bacteria.
Class II - Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits manufactured with the recalled swabsticks, Lot No. 812873 - Class I. Kits containing swabsticks with Lot Nos. 800468, 807006, 815959, 900359, 818749, 900559, 900560, 902649, 905001 and 911138, for which the sterility could not be assured - Class II.

PRODUCT Various Kits containing Iodophor PVP Povidone 1% Solution Antiseptic, 1 fluid ounce recalled by Clinipad Corporation.
CODE All lot numbers.
MANUFACTURER Cook, Inc., Bloomington, Indiana.
DISTRIBUTION Nationwide and international.
QUANTITY 60,000 kits were distributed.
REASON Class I - Products may be contaminated with bacteria.
Class II - Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits with the antiseptic solution, Reorder #394-SB, Lot No. 812422 - Class I. Kits with antiseptic solutions with Lot Nos. other than 812422, for which the sterility could not be assured - Class II.

PRODUCT Various Custom Procedural Kits containing antiseptic products recalled by Clinipad Corporation.
CODE (Note: If necessary, a complete of catalog and lot numbers can be obtained from the Los Angeles District Office.
MANUFACTURER Professional Hospital Supply, Inc., Temecula, California.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON The antiseptic products may be contaminated with bacteria.

PRODUCT Kits/Trays containing recalled Clinipad products, 86 different Cook catalog order numbers. (Note: If necessary, a complete list of devices, catalog and lot numbers can be obtained from the Detroit District Office Recall Coordinator).
CODE All catalog order numbers containing one of the following five prefixes: J-CHSGY, J-MHSGY, J-SBHS, J-TCY, AND J-DANY.
MANUFACTURER Cook Urological, Spencer, Indiana.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 13,812 kits.
REASON Kits/trays contain Clinipad products labeled as sterile which Clinipad is unable to assure the sterility.

PRODUCT a) Bard Button Device Decompression Tubes; b) Bard Replacement Gastrostomy Device Kit
CODE All lot numbers.
MANUFACTURER C.R. Bard, Inc., Mentor, Ohio.
RECALLED BY C.R. Bard, Inc., Billerica, Massachusetts
DISTRIBUTION Nationwide.
QUANTITY 63,345 units were distributed.
REASON The device may be partially occluded (due to mold flash) causing narrowing in the through-hole.

WEEK ENDING JULY 21

PRODUCT Bivona FlexTend Plus Pediatric Cuffless Tracheostomy Tube.
CODE Catalog #60PFP45, Lot #888100.
MANUFACTURER Bivona Medical Technologies, Gary, Indiana.
DISTRIBUTION New Jersey and Pennsylvania.
QUANTITY 47 units were distributed.
REASON A package contained a standard FlexTend Tube.

PRODUCT Sterostatic Neurosurgery Planning System, SteroPlan 2.0 and SteroPlan 2.1.
CODE Catalog No. STERO-SW-2.
MANUFACTURER Radionics, Burlington, Massachusetts.
DISTRIBUTION Nationwide and international.
QUANTITY 44 units were distributed.
REASON position errors up to 2.5 mm may be observed if the user removes a slice from a CT or MRI image after the image has been fused and a fusion matrix has been generated.

PRODUCT Healthdyne SmartMonitor series Infant Apnea Monitors.
CODE Catalog Numbers - 900S, 900S-02, 900S-02-01, 900S-02-04, 900S-02-07, 900SL, 970S, 970S-02, 970S-02-01, 970SE, 970SE-02, 970SE-02-04, 970SE-02-07. Note: serial numbers relate to year and month. A-L=January-December; first numerical character defines year, 5-9=1995-1999. This recall involves all type 3A and 3B SmartMonitors Infant Apnea Monitors manufactured between 12/1/95 to 1/15/2000.
MANUFACTURER Respironics, Inc., Marietta, Georgia.
DISTRIBUTION Nationwide and international.
QUANTITY 28,000 units were distributed.
REASON The electrical circuit on the display printed circuit board can become damaged.

PRODUCT Medtronic AneuRx Stent Graft System, designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms using an endovascular approach.
CODE
Catalog Number Tapered Tip Reusable Handle
YREC1855         NA
YREC20375         PD03140-20
YREC22375         PD03140-22
YREC24375         PD03140-24
YREC26375         PD03140-26
YREC28375         PD03140-28
YREC31375         NA
YRBR2012135     PD03138-20
YRBR2213135     PD03138-22
YRBR2414135     PD03138-24
YRBR2615135     PD03138-26
YRBR2816135     PD03138-28
YRBR3116135     NA
YRBR2012165     PD03139-20
YRBR2213165     PD03139-22
YRBR2414165     PD03139-24
YRBR2615165     PD03139-26
YRBR2816165     PD03139-28
YRBR3116165     NA
Catalog Number IDS
YRDEC1855         PD02457-18
YRDEC20375         PD02457-20
YRDEC22375         PD02457-22
YRDEC24375         PD02457-24
YRDEC26375         PD02457-26
YRDEC28375         PD02457-28
YRDEC31375         PD02457-31
YRDBR2012135     PD02087-20
YRDBR2213135     PD02087-22
YRDBR2414135     PD02087-24
YRDBR2615135     PD02087-26
YRDBR2816135     PD02087-28
YRDBR3116135     PD02087-31
YRDBR2012165     PD02086-20
YRDBR2213165     PD02086-22
YRDBR2414165     PD02086-24
YRDBR2615165     PD02086-26
YRDBR2816165     PD02086-28
YRDBR3116165     PD02086-31
MANUFACTURER Medtronic, Inc., Minneapolis, Indiana.
RECALLED BY Medtronic AVE, Santa Rosa, California
DISTRIBUTION Nationwide.
QUANTITY 230 units were distributed.
REASON Product has the potential for detachment of a 21F-tapered tip nosecone from the catheter.

PRODUCT Merit Majestic Series, angiographic needle: a) Catalog No: AN19U31W; b) Catalog No. AN19U71W; c) Catalog No. K10-01394P.
CODE Lot Numbers: a) A133547 and A140201; b) A131089, A133549, and A138174; c) A129650 and A134029.
MANUFACTURER Merit Medical Systems, Inc., South Jordan, Utah.
DISTRIBUTION Nationwide, Canada, France.
QUANTITY 1,929 units were distributed.
REASON The needle hub may be brittle and could fracture during use.
 

SEIZURE ACTIONS

PRODUCT Dietary Supplements (Z23, Opti-Cran, Vitamin C (& Ginseng coated), Garlic, Uva Ursi, Saw Palmetto, Ginkgo Biloba, St. John's Wort). (1812-1817, 48978/80 & 5071/5075, and 82623-82630).
CHARGES New Drug and Misbranded - Products are unapproved new drugs represented as dietary supplements and they fail to bear adequate directions for use.
LOCATION Hillestad Pharmaceuticals, Woodruff, Wisconsin.
FILED May 3, 2000 - U.S. District for the Western District of Wisconsin. Civil #00C02625; FDC #67294.
SEIZED May 17, 2000 - Goods approximately 376 cases valued at $500,999 and bulk tablets valued at $79,000.

PRODUCT T3 Metabolite (730).
CHARGES New drug, misbranded, and alternative food, adulterated - Product is an unapproved new drug represented as dietary supplement, which fails to bear adequate directions for use. Alternative food charges-risk of illness or injury, poisonous or deleterious.
LOCATION One World Fulfillment Distribution, Inc., Mobridge, South Dakota.
FILED June 1, 2000 - U.S. District Court for the District of South Dakota, Northern Division. Civil #CIV00-1015; FDC #67405.
SEIZED June 8, 2000 - 927 bottles valued $32,400.

WEEK ENDING JULY 28

PRODUCT Neostar Dialysis Catheter Kits and Central Venous Catheter Kits under the following labels:
Neostar Chronic Dual Lumen Catheter Kit - Product Code Numbers AC-190K, AC-190KC, AC-190KC-WING, AC-230K, AC-230KC, AC-230KCAL, AC-230KC-WING, AC-230KC-WINGED, AC-270K, AC-270K-WING, AC-280KC, AC-280KC-TV01, AC/DLC-190KC.
Neostar Chronic Catheter Placement Kit - Product Code Number AC-K, AC-KC
Neostar Acute CAVH Catheter Kit - Product Code Numbers CAVH-1045K, CAVH-1060K, CAVH-945K, CAVH-960K
Neostar Dual Lumen CV Tunneled Catheter Kit - Product Code Numbers CV-111K, CV-112K, CV-221K, CV-222K, CV-223K, CV-224K
Neostar Triple Lumen CV Tunneled Catheter Kit - Product Code Number CV-331K
Pheres Flow Triple Lumen Catheter Kit - Product Code Numbers CV-332AK, CV-332BK, CV-332K, CV-332K-NE01, CV-332K-NE02
Neostar Acute Dual Lumen Catheter - Product Code Numbers DLC-400KJ, DLC-500K, DLC-500KC, DLC-500KEC, DLC-500KJ, DLC-511KC, DLC-511KEC, DLC-511KJ, DLC-600K, DLC-600KC, DLC-600KC-AL, DLC-600KC-D101,DLC-600KC-H001, DLC-600KC-SU02, DLC-600KEC, DLC-600K-EC01, DLC-600KJ, DLC-600KLC, DLC-700KC, DLC-700KC-AM01, DLC-700KEC, DLC-700KJ, DLC-800K, DLC-800KC, DLC-800KC-AL, DLC-800KC-D101, DLC-800KC-D102, DLC-800KC-H002, DLC-800KC-HY02, DLC-800KEC, DLC-800K-EC01, DLC-800KEC-AL, DLC-800KJ, DLC-800KJC
Neostar Peritoneal Insertion Kit - Product Code Numbers PC-K, PC-K-HY01, PC-K-HY02
Neostar Acute Single Lumen Catheter Kit - Product Code Numbers SLFC-1500K, SLFC-2400K, SLJC-1300K, SLJC-1700K, SLSC-1500K, SLSC-2000K. .
CODE
Neostar Chronic Dual Lumen Catheter Kit - Lot Numbers - AT461, AU145, AU191, AU319, AU356, AU385, AV131, AV161, AV205, AV235, AV274, AV330, AV348, AV373, AV381, AV399, AV423, SE97188, SE97240, SE97288, SE98066-1, SE98123, SE98300, SE98323, SE98326, SE98334, AT446, AT462, AT563, AU185, AU202, AU238-1, AU241, AU263, AU289, AU305, AU358, AU386, AV122, AV150, AV165, AV193, AV198, AV206, AV236, AV260, AV275, AV298, AV312, AV325, AV359, AV368, AV387, AV406, AV427, AV431, SE96023, SE97009, SE97037, SE97119, SE97144, SE97151, SE97156, SE97201, SE97215, SE97234, SE97243, SE97248, SE97250, SE97258, SE97297, SE97302, SE97325, SE97329, SE98022, SE98031, SE98035, SE98047, SE98058, SE98063, SE98065, SE98098, SE98108, SE98133, SE98142, SE98146, SE98147, SE98148, SE87175, SE98184, SE98194, SE98197, SE98198, SE98200, SE98210, SE98217, SE98223, SE98227, SE98231, SE98233, SE98234, SE98238, SE98239, SE98245, SE98253, SE98276, SE98278, SE98285, SE98286, SE98290, SE98327, SE98396, SE98399, SE98403, SE98417, SE98421, SE98422, SE98470, SE98475, SE98479, SE98484, SE98497, SE98506, SE98518, SE98522, SE99014, SE99021, SE99022, SE99049, SE99055, SE99060, SE99067, SE99092, SE99094, SE99095, SE99122, SE99142, SE99152, SE99175, SE99177, SE99193, SE99195, SE99199, SE99202, SE99213, SE99227, SE99234, SE99239, SE99257, SE99265, SE99274, AU146, AU192-1, AU243, AU281, AU316-1, AU384, AV132, AV160, AV207, AV296, SE97076, SE97203, SE97205, SE98117, SE98122, SE98301, SE98472, SE99010, SE99020, SE99041, AT444, AT463, AT564, AU142, AU198, AU264, AU297, AU306, AU333, AU359, AU387, AV125, AV163, AV166, AV189, AV208, AV237, AV276, AV297, AV311, AV323, AV337, AV363, AV390, AV407, AV408, AV428, AV439, SE96024, SE97010, SE97032, SE97053, SE97120, SE97136, SE97150, SE97172, SE97191, SE97221, SE97229, SE97232, SE97233, SE97245, SE97249, SE97259, SE97294, SE97298, SE97309, SE98005, SE98021, SE98036, SE98042, SE98046, SE98061, SE98111, SE98118, SE98130, SE98149, SE98162, SE98170, SE98182, SE98186, SE98189, SE98203, SE98209, SE98221, SE98228, SE98235, SE98236, SE98240, SE98243, SE98247, SE98275, SE98277, SE98287, SE98307, SE98316, SE98322, SE98400, SE98405, SE98408, SE98411, SE98418, SE98420, SE98423, SE98429, SE98438, SE98446, SE98474, SE98482, SE98487, SE98488, SE98494, SE98505, SE98509, SE98516, SE99017, SE99026, SE99027, SE99032, SE99056, SE99066, SE99068, SE99087, SE99102, SE99106, SE99113, SE99114, SE99116, SE99118, SE99128, SE99133, SE99138, SE99141, SE99143, SE99182, SE99185, SE99218, SE99238, SE99258, SE99302, AV266, AV202, SE97152, SE97157, SE97184, SE97209, SE97211, SE97322, SE98013, SE98062, SE98115, SE98138, SE98140, SE98145, SE98176, SE98181, SE98187, SE98344, SE98397, SE98401, SE98460, SE98467, SE98499, SE98515, SE99003, SE99008, SE99031, SE99033, SE99036, SE99043, SE99088, SE99093, SE99151, SE99181.
Neostar Chronic Catheter Placement Kit - Lots SE97199, SE98391, AU389, AV190, AV272, SE97018, SE97050, SE97158, SE97212, SE98001, SE98015, SE98016, SE98125, SE98134, SE98190, SE98193, SE98260, SE98390, SE98468, SE98469, SE98473, SE98496, SE98502.
Neostar Acute CAVH Catheter Kit - Lots AT542, AU195, AU267, AV196, AV251, AV295, AV388, SE97093-1, SE97163-1, SE98432, SE98434, AT546, AU288, AT469, AV133, AV178, AV209, AV177, AV248, SE97227.
Neostar Dual Lumen CV Tunneled Catheter Kits - Lots AT484, AT531, SE97100, SE97206, SE99121, SE99124, SE99209, SE99303, SE97101, SE97166, AU171-1, SE97214, SE97228, SE98312, SE97230, AV238, SE96031, SE97043, SE97124, SE97241, AU174-1, AV121, SE97125, SE97208, SE97318, SE98333.
Neostar Triple Lumen CV Tunneled Catheter Kits - Lots AT456-1, SE97049, SE97132, SE97225, SE97256, SE98295, SE98313, SE99153, SE99277, SE99304.
Pheresis Flow Triple Lumen Catheter Kits - Lots AT440, AT540, AT441, AT541, AU287, AV119, AV151, AV197, AV201, AV210, AV258, AV290, AV313, AV321, AV386, AV402, AV415, AV426, SE96014, SE97011, SE97036, SE97067, SE97089, SE97121, SE97138, SE97147, SE97164, SE97178, SE97207, SE97216, SE97231, SE97246, SE97247, SE97283, SE97293, SE97304, SE97310, SE97323, SE97324, SE97330, SE98006, SE98014, SE98032, SE98034, SE98039, SE98043, SE98044, SE98048, SE98102, SE98103, SE98143, SE98164, SE98166, SE98173, SE98188, SE98191, SE98195, SE98199, SE98211, SE98215, SE98224, SE98225, SE98237, SE98241, SE98248, SE98250, SE98254, SE98255, SE98262, SE98263, SE98264, SE98265, SE98272, SE98281, SE98284, SE98288, SE98315, SE98325, SE98350, SE98386, SE98394, SE98402, SE98404, SE98409, SE98437, SE98444, SE98448, SE98450, SE98461, SE98465, SE98476, SE98483, SE98491, SE98493, SE98498, SE98501, SE98503, SE98508, SE98510, SE98513, SE98519, SE08521, SE99001, SE99034, SE99052, SE99054, SE99058, SE99065, SE99069, SE99078, SE99100, SE99117, SE99162, SE99184, SE99196, SE99198, SE99219, SE99297.
Neostar Acute Dual Lumen Catheter Kits - Lots AT186, AV113-1, AU169, AT205, AT470, AT496, AU269, SE97175-1, SE98463, AT110, AT181, AT209, AT214, AT315, AR321-1, AT471, AT569, AT443, AT465, AT520, AT552, AU139, AU159, AU181, AU204, AU214, AU231, AU251, AU253, AU274, AU315, AU323, AU349, AU364, AU373, AU375, AV115, AV144, AV174, AV184, AV188, AV211, AV233, AV239, AV253, AV254, AV268, AV273, AV299-1, AV303, AV316, AV318, AV335, AV358, AV385, AV397, AV400, AV420, SE7024-1, SE97057, SE97074, SE97077, SE97103, AV97104, SE97113, SE97114, SE97139, SE97148, SE97153, SE97220, SE97269, SE97270, SE97284, SE97285, SE98029, SE98030, SE98078, SE98079, SE98091, SE98101, SE98104, SE98109, SE98110, SE98153, SE98165, SE98381, SE98382, SE98426, SE98428, SE98439, SE98440, SE98459, SE98492, SE98495, SE98500, SE98504, SE98514, SE99015, SE99025, SE99028, SE99030, SE99098, SE99104, SE99119, SE99161, SE99172, SE99201, SE99221, SE99306, AT521, AU160, AU161, AU182, AU205, AU254, AU310,AU325, AU350, AU396, AV116, AV148, AV175, AV185, AV212, AV240, AV247, AV293, AV310, AV384, AV392, SE97033, SE97058, SE97082, SE97112, SE97141, SE97160, SE97263, SE97278, SE97286, SE97287, SE97316, SE98045, SE98055, SE98067, SE98077, SE98087, SE98090, SE98160, SE98183, SE98201, SE98204, SE98207, SE98208, SE98213, SE98268, SE98270, SE98283, SE98354, SE98520, SE99029, SE99073, SE99076, AT114, SE98489, SE99144, SE99163, SE99165, SE99166, SE99189, SE99214, SE99225, SE99231, SE99237, SE99245, SE96019-1, SE97042, SE97183, SE97222, AS530, AT111, AT182, AT210, AT213, AT314-1, AT320-1, AT459-1, SE96016, AT467, AT551, AT568, AU127-1, AU156, AU178, AU206, AU208, AU232, AU252, AU276, AU314, AU327, AU352, AU374, AU376, AV117, AV145, AV169, AV186, AV213, AV234, AV241, AV252, AV256, AV270-1, AV294-1, AV306-1, AV317, AV319, AV334, AV353, AV383, AV396, AV414, AV421, SE96017, SE97030, SE97059, SE97084, SE97105, SE97106, SE97111, SE97134, SE97145, SE97146, SE97159, SE97219, SE97265, SE97272, SE97300, SE97301, SE97332, SE98038, SE98071, SE98072, SE98081, SE98083, SE98084, SE98085, SE98089, SE98095, SE98144, SE98150, SE98152, SE98168, SE98226, SE98371, SE98375, SE98379, SE98441, SE98447, SE98449, SE99004, SE99006, SE99016, SE99023, SE99035, SE99050, SE99071, SE99096, SE99103, SE99108, SE99120, SE99167, SE99180, SE99183, SE99186, SE99197, SE99200, SE99222, AU157, AU162, AU179, AU201, AV118, AV147, AV170, AV171, AV214, AV242, AV269, AV309, AV329, AV333, AV374, AV391, SE97025-1, SE97055, SE97085, SE97107, SE97117, SE97140, SE97161, SE97264, SE97266, SE97274, SE97281, SE97306, SE97315, SE87317, SE97319, SE98004, SE98023, SE98070, SE98080, SE98093, SE98151, SE98161, SE98192, SE98214, SE98216, SE98249, SE98261, SE98269, SE98273, SE98282, SE98337, SE98351, SE98523, SE99002, SE99057, AT180, AT475, SE99150, SE99155, SE99156, SE99168, SE99187, SE99205, SE99215, SE99223, SE99264
Neostar Peritoneal Insertion Kit - Lots AU144, AU307, AU337, AU388, AV320, AV357, AV389, SE96025, SE97004, SE97118, SE97200, SE97296, SE98002, SE98041, SE98251, SE98392, SE98412, AV112, AV162, AV225, AV243.
Neostar Acute Single Lumen Catheter Kits - Lots AV172, AV250, AV308, AV376, SE96028, SE97013, SE97040, SE97202, SE97217, SE97223, SE97260, SE97262, SE97303, SE98128, SE98158, SE98291, AT516, SE96015, SE97034, SE97128, SE97236, SE98353, AU292, AV153, AV371, SE96029, SE97014, SE97035, SE97061, SE98177, AV158, AV398, SE96030, SE97015, SE97045, SE97062, SE97102, SE98167, SE98178, SE98360.
MANUFACTURER Horizon Medical Products, Manchester, Georgia.
DISTRIBUTION Nationwide and international.
QUANTITY Excess of 100,000 units.
REASON The device package may contain pinholes.

PRODUCT Narkomed MRI Anesthesia System, gas machine for anesthesia.
CODE All units shipped prior to June 7, 2000.
MANUFACTURER North American Drager, Telford, Pennsylvania.
DISTRIBUTION Nationwide, Canada, Egypt, Hong Kong, Israel, Puerto Rico.
QUANTITY 122 units were distributed.
REASON Fresh gas delivery to the vaporizer is reversed resulting in fresh gas flowing backwards through the vaporizer.

PRODUCT Medtronic Mosaic(r) Procine Bioprosthesis: a) Medtronic Mosaic Aortic Valves, Model Nos. 30519, 30521, 30523, 30525, 30527; b) Medtronic Mosaic Mitral Valves, Model Nos. 31025, 31027, 31029, 31031, 31033.
CODE Each bioprosthesis carries an individual serial number. They are too numerous to list.
MANUFACTURER Medtronic Heart valves, Santa Ana, California.
DISTRIBUTION Nationwide and international.
QUANTITY 529 units were distributed.
REASON A misinterpretation in measurement of coaptation depth by a technician resulted in the release of out-of-specification devices.

PRODUCT Intraocular Lenses: Basic Phakic AC-50 refractive lens was the first model produced in 1995 and was subsequently replaced by ACN-60 and ACP-60 in 1996.
a) Anterior Chamber Negative ACN-60) lenses for myopic correction (with or without serial numbers assigned);
b) Anterior Chamber Positive (ACP-60) lenses for hyperopic correction (with or without serial numbers assigned);
c) Phakic 6 Refractive Anterior Chamber Lens for both myopic and hyperopic powers (with/without heparin coating and with/without serial numbers assigned).
CODE There are 156 lenses affected, some are assigned a serial number and some are not. The large number of affected units preclude their being listed here.
MANUFACTURER Ophthalmic Innovations International, Inc., Claremont, California.
DISTRIBUTION Undetermined.
QUANTITY 155 lenses were implanted.
REASON The firm failed to obtain an approved IDE (investigational device exemption or PMA (premarket approval).

PRODUCT a) OSF-2 Suction Barb Assembly, for use in kit #C1411 QCK; b) Flow Adaptor Sub-assembly, for use in kit #C1440 QCK; c) Quick Connect Kit, #C1411, for use on Olympus OSF-2 Flexible Sigmoidoscope
CODE Steris Catalog/Part Numbers for the affected 3 devices are: 200367, 200587, and C1411. The Steris Part Number for the defective restrictor component is: 400402.
MANUFACTURER Steris Corporation, Mentor, Ohio.
DISTRIBUTION Indiana, California, Pennsylvania, Texas, New Jersey.
QUANTITY 9 affected devices contain 41 restrictors.
REASON Metal shavings were found in Steris Quick Connect Kits used with endoscopic device.

PRODUCT Dialysis Reverse Osmosis Water System, single unit/stand alone water treatment system used in hemodialysis applications, designed to pre-treat and purify potable water for use in making dialysate for hemodialysis: a) Model MROS; b) Model MRO1; c) MRO2.
CODE Serial Numbers: 97002 to 97038.
MANUFACTURER Ameriwater, Dayton, Ohio.
DISTRIBUTION Nationwide, British Virgin Islands.
QUANTITY 35 devices were distributed.
REASON Device fails to meet specifications prior to distribution.