MARCH 2000

WEEK ENDING MARCH 3

PRODUCT IMx Glycated Hemoglobin Ion Capture Component Set, list 1A86-88, 100 test kit; an ion capture assay for the quantitative measurement of percent glycated hemoglobin in human anticoagulated whole blood on the IMx Analyzer.
CODE List # 1A86-88. Set Lot Numbers: 56566M200, 56568M200, 57411M200, 58079M100, 58157M400, 58332M200, 59545M200, 60274M300, 60275M300, 60276M300, 60277M300, 60278M300.
MANUFACTURER Abbott Laboratories, Inc., North Chicago, Illinois.
RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois
DISTRIBUTION Nationwide and international.
QUANTITY 27,444 sets were distributed.
REASON The kits may not quantitate the %GHb or give imprecise results.

PRODUCT Endontic File.
CODE Part #259446, Lot Numbers: 100799, 110199, 121899 and 051199.
MANUFACTURER Maillefer Instruments SA, Ballaigues, Switzerland.
RECALLED BY Den-Tal-EZ, Inc., Lancaster, Pennsylvania
DISTRIBUTION Pennsylvania, Georgia, Texas, Florida, Indiana, New York, Illinois, Minnesota, Washington state, Japan.
QUANTITY 94 units were distributed.
REASON Mislabeled - The wrong size Endostar Files were packaged in part number 259446.

WEEK ENDING MARCH 10

PRODUCT Image X 70 Dental X-Ray System, used in dental radiography.
CODE Model Image X 70.
MANUFACTURER De Gotzen S.r.l. Legnano, Italy.
RECALLED BY AFP Imaging Corporation, Elmsford, New York
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,400 units.
REASON The diagnostic x-ray devices were found defective under 21 CFR 1003.11. The defect occurs as a result of incomplete equipment specifications and labeling on equipment manufactured by de Gotzen S.r.l., Legnano, Italy for DENTX (a subsidiary of AFP).

PRODUCT NC-4 Microscope Stand.
CODE Non-sequential Serial Numbers 31352 through 313654.
MANUFACTURER Carl Zeiss, Inc., Oberkochen, Germany.
RECALLED BY Carl Zeiss, Inc., Thornwood, New York
DISTRIBUTION Nationwide and international
QUANTITY 189 units were distributed.
REASON The vertical carrier arm has the potential to break causing the device to become inoperative.

PRODUCT Konica MD-100 Mammography Screens, indicated for use as an accessory to a cassette to convert x-ray energy into light energy.
CODE Lot Numbers 8J**** and 5A****.
MANUFACTURER onica Medical Imaging, Inc., Wayne, New Jersey.
DISTRIBUTION California, Connecticut, Florida, Missouri, New York, Oregon, Texas.
QUANTITY 38 units (size 18cm X 24 cm,) and 13 units (size 24 cm X 30cm) were distributed.
REASON The screens cause negative densities on the x-ray film, which could result in a misreading.

PRODUCT Vitalcom ST Segment Arrhythmis Detection Software Option, an Optional ECG software feature used in conjunction with the Critikon Observer Central Station on which is installed. There are 12 models or catalog numbers of the software option involved as follows:
88951-8 Patient Arrhythmia, S-T, 24 hour Disclosure Software (Hardwire)
88961-8 Patient Arrhythmia, S-T, 1 hour Disclosure Software (Hardwire)
88971-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (Hardwire)
88991-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (Hardwire)
88911-8 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (900MHz)
88921-8 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (900 MHz)
88931-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (900 MHz)
88941-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (900 MHz)
88821-8 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (VHF)
88831-8 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF)
88841-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (VHF)
88851-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF).
CODE The only reference numbers are the Catalog Numbers listed above.
MANUFACTURER Vital Com, Tustin, California (software).
RECALLED BY Critikon Company LLC, Tampa, Florida (distributor)
DISTRIBUTION Tennessee, Texas, Missouri, Georgia, Wisconsin, Illinois, South Carolina, Ohio, Alabama, Egypt.
QUANTITY There are 15 OBSEVER Central Stations with the VitalCom ST Segment Arrhythmia Detection Software Option installed in commerce.
REASON The software validation of version 4.01R1 a software anomaly was found that affected the proper function of a print option.

PRODUCT Tina System 1000 and Altra Touch 1000 Single Patient Hemodialysis Delivery Systems.
CODE All serial numbers 12,500 and below.
MANUFACTURER Althin Medical, Inc., Miami Lakes, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 4,972 units were distributed nationally and 695 units were distributed internationally.
REASON Linear clamp may not achieve proper occlusion.

PRODUCT a) Single Channel b) Triple Channel Volumetric Infusion Pumps, for continuous or intermittent fluid delivery through clinically
acceptable routes of administration.
CODE All serial numbers of the following pumps a) Colleague Infusion Pump - Single Channel Product code 2M8151 - U.S. Distribution;
2M8151R - Refurbished, U.S. Distribution; 2M8151K - CE Marked, English language; FKM8151 - English language; HNM8151 - CE marked, German language; PNM8151 - CE marked, Spanish language; DNM8151 - CE marked, French language;
b) Colleague 3 Infusion Pump - Triple Channel Product code 2M8153 - U.S. distribution; 2M8153R - Refurbished, U.S. distribution.
MANUFACTURER Baxter Healthcare PTE., Ltd., Singapore.  Namiki Percision Jewel Company Ltd., Tokyo, Japan (motors).
RECALLED BY Baxter Healthcare Corporation, Round Lake, Illinois
DISTRIBUTION Nationwide and international.
QUANTITY 78,000 pumps were distributed.
REASON Motors burn out at 15-18 months of age.

PRODUCT Infinity Modular Bedside Monitors, Models SC7000, SC8000, SC9000, SC9000XL, intended for adult, pediatric, and neonatal monitoring of clinical environment.
CODE Infinity Modular Monitors: SC7000, SC8000, SC9000, SC9000XL with software versions VEO, VEO.1 or VEO.2
MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts.
DISTRIBUTION Arkansas, Arizona, California, Florida, Kentucky, Georgia, Illinois, Michigan, New Mexico, New York, Ohio, South Dakota, Tennessee, Texas.
DISTRIBUTION 140 units were distributed.
REASON Failure to correctly re-calculate drug dosage using saved Drug Dosage Data.

PRODUCT Chrome plated brass circumcision clamps, gomco like, made in Pakistan, individually packaged clamps in boxes labeled only
with the catalog number, description, size and quantity.
CODE All units of the following clamps Catalog #83928, 1.1 cm, Extra Small Catalog #83929, 1.3 cm, Newborn Catalog #83930, 1.6 cm, Child.
MANUFACTURER Gogi Enterprises, Sialkot, Punjab, Pakistan.
RECALLED BY Medco Instruments, Inc., Crestwood, Illinois
DISTRIBUTION Nationwide.
QUANTITY 2,000 clamps were distributed.
REASON Lack of 510(k) approval, inadequate instructions for use, and failure to file MDRs.

PRODUCT a) 2-way MainFrame Interface Software Version 22.20; b) Pediatric Therapy Guide Version 4.10.
CODE Part Numbers: 9800-2666 and 9800-0630; Catalog Numbers: B1018-15 and B1011-30.
MANUFACTURER Dade Microscan Inc., West Sacramento, California.
DISTRIBUTION Nationwide and international.
QUANTITY 90 copies were distributed.
REASON Potential for incorrect Pediatric Reports--A software problem.

PRODUCT EBI XFIX Dynafix DFS Hybrid Fixator, designed for the stabilization of intra and peri-articular fractures
where the fracture pattern and available bone stock precludes the introduction of larger diameter bone screws:
a) Variable Wire Carriage (Part No. 13070); b) Variable Bone Screw (Part No. 13080).
CODE All lot numbers - Products produced from 8/11/97 to 6/23/99.
MANUFACTURER EBI, L.P., Parsippany, New Jersey.
DISTRIBUTION Nationwide, Spain, Puerto Rico.
QUANTITY a) 7,000 units; b) 3,241 units were distributed.
REASON The carriage locking bolt component for both devices can break, potentially resulting in the loss of fracture reduction/ distraction postoperatively.

PRODUCT Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI.
CODE Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P, BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P, BA110P, BA131D, and BA192D.
MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio.
DISTRIBUTION Florida, Maryland, Massachusetts, Utah, Arizona, Australia, Italy, Germany, Japan, China and England.
QUANTITY 19 units were distributed.
REASON Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter.

PRODUCT Smit Sleeves, an accessory to various applicators used with the Nucletron mHDR afterloader, a plastic tube with drainage holes inserted into endometrium and may be sutured into place to allow cervix to remain dilated for easier reinsertion of intrauterine tube for subsequent treatment. Part #ís 086.047 and 086.048 413/414-0.
CODE Lot #ís 480301 to 490908.
MANUFACURER NUCLETRON BV, The Netherlands.
RECALLED BY Nucletron, Columbia, Maryland
DISTRIBUTION Nationwide.
QUANTITY 1,061 units were distributed
REASON Brachytherapy applicator sleeve may become disconnected during treatment.

PRODUCT Deltec Port-A-Cath II Polysulfone/Titanium Venous System, Product #21-4065-01. The product trays each contain a portal, a catheter and an introducer set, for the delivery of fluids and drugs
CODE Lot numbers: 66947, 67687, 67946 and 68378.
MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota.
DISTRIBUTION Nationwide.
QUANTITY 187 access systems were distributed.
REASON Separation of the catheter from the drug portal can result in leaks.

PRODUCT Tecan Genesis Disposable Tip.
CODE Catalog #71-705, Lot Numbers: 15169, 16169, 17169, 11179, 25169, 26169, 27169, 35169, 36169, 37169.
MANUFACTURER Eppendorf, Hamburg, Germany.
RECALLED BY Tecan U.S. Inc., Durham, North Carolina
DISTRIBUTION Arizona, California, Florida, Illinois, Wisconsin.
QUANTITY 2,720 boxes were distributed.
REASON Manufacturing error - Crack in 1000ul tip.

PRODUCT Premier Platinum HPSA, an ELSIA assay for the detection of Helicobacter pylori antigens in stool, Product #601348.
CODE Lot #601348.024
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Alabama, Arizona, California, Georgia, Iowa, Kansas, Michigan, Montana, New Jersey, New York, Ohio, Oregon, Texas, Utah, Wisconsin, Florida, Honduras, Chile, Japan, German, Italy.
QUANTITY 457 test kits were distributed.
REASON The kits may contain microwells intended for detection of C. difficile Toxin A.

WEEK ENDING MARCH 17

PRODUCT APLIGRAF (GRAFTSKIN) Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial or full-thickness skin ulcers.
CODE Packaging run GS991109.03.2A. Unit Numbers: 35, 36, 37, 39, 40, 41, 42, 43, 44, 45, 48, 49, 50, 51, 52, 53, 54, 55, 56, 58, 59, 60, 61, 63, 64, 65, 66, 67, 68, 69, 70 and 71.
MANUFACTURER Organogenesis, Inc., Canton, Massachusetts.
DISTRIBUTION Arizona, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas.
QUANTITY 32 units were distributed.
REASON Product was contaminated with Burkholderia cepecia.

PRODUCT Servo Ventilator 300 and Servo Ventilator 300A, an intensive care ventilator that can be used on patients ranging from neonates to adults.
CODE Siemens Servo Ventilator 300 and Servo Ventilator 300A Codes: Model 300/300A: Serial Number 2757 to 16348 Codes: Model 300/300A: Serial Number: 8830 and higher.
MANUFACTUER Siemens-Elema AB, Solna, Sweden.
RECALLED BY Siemens Medical Systems, Inc., Danvers, Massachusetts
DISTRIBUTION Nationwide.
QUANTITY 5,200 units were distributed.
REASON Higher trigger sensitivity than expected in neonate setting and frozen alpha value.

PRODUCT Stryker Endoscopy Cholangiogram Kit, a catheter used to introduce dye into the common bile duct to facilitate an X-ray to check for bilestones.
CODE 250-10-430.
MANUFACTURER Stryker Endoscopy, Santa Clara, California.
DISTRIBUTION Nationwide and international.
QUANTITY 1,522 units were distributed.
REASON Failure to include latex and natural rubber disclosure statement.

PRODUCT Biolaser, used for biostimulation: a) Model 1000; b) Model 2000.
CODE Models 1000 and 2000.
MANUFACTURER Bio-Laser Response Corporation, Castle Rock, Colorado.
DISTRIBUTION Nationwide.
QUANTITY a) 3 units; b) 6 units were distributed.
REASON The devices are adulterated, misbranded, and failed to comply with 21 CFR 1040.10 and 11 in that the models have numerous noncompliance.

PRODUCT Mechanical Wheelchair.
CODE XTR-4586 sold between 11/05/98 and 01/10/00.
MANUFACTURER Sunrise Medical Inc., Fresno, California.
DISTRIBUTION Nationwide and international.
QUANTITY 756 units were distributed.
REASON Poor design - User can fall backwards and there is potential for injury.

PRODUCT Allograft Heart Valves: Model PV05, PV00 and AV05.
CODE Serial Numbers - 6150896, 6305342, and 6309992.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Texas, West Virginia, Germany.
QUANTITY 3 valves were distributed.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT Allograft Heart Valve, Model PV05.
CODE Serial Numbers: 6268404 and 6310001.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Washington state and Texas.
QUANTITY 2 valves.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT Allograft Heart Valve, Models PV00 and AV00.
CODE Serial Numbers: 6668691 and 6668704.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Arizona and New Jersey.
QUANTITY 2 valves.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT Human Heart Valves, frozen and processed for transplantation.
CODE 52 human heart valves uniquely identified by a 10-digit alpha-numeric code.
MANUFACTURER Lifenet, Virginia Beach, Virginia.
DISTRIBUTION Nationwide.
QUANTITY 52 valves.
REASON Sera from donors of human tissues were not tested using validated methods.

PRODUCT IntraStent Biliary Endoprosthesis, 36 mm in length. The product was labeled for foreign distribution as IntraStent Peripheral Stent, 36 mm in length, Product Number S10-36 on both labels, intended for permanent implant.
CODE Lot 19931207 of the Biliary Endoprosthesis, and lot 19933703 of the Peripheral Stents.
MANUFACTURER Intratherapeutics, Inc., St. Paul, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 128 stents were distributed.
REASON The stent length was incorrectly identified on the product labels as 36mm, rather than the actual length of 26 mm.

PRODUCT Trocar Needle for use in interstitial treatment prior to brachytherapy of patient: Part Numbers: 083.914, 083.918, 083.920, 083.922, 083.924, 083.926.
CODE Lot numbers 480505 to 481130.
MANUFACTURER Nucletron BV, The Netherlands.
DISTRIBUTION Nationwide.
QUANTITY 654 devices were distributed.
REASON Tip of trocar needle separated from body of needle leaving tip in the patient.

WEEK ENDING MARCH 24

PRODUCT Elecsys Troponin T Immunoassay for the in-vitro quantitative determination of troponin T in human serum and plasma: a) Catalog #2017423, Elecsys Tronponin T STAT Immunoassay, 100 Tests; b) Catalog 2017644, Elecsys Tronponin T Immunoassay, 100 test.
CODE a) Lot Numbers: 19862701 EXP 12-31-2000 and 19829401 EXP 03-31-2000; b) 19864201 EXP 12-31-2000.
MANUFACTURER Roche Diagnostics Corporation, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY Approximately 13,000 units.
REASON The devices may give test results lower than actual troponin T results when heparinized plasma samples are used.

PRODUCT Strep A Tests, an in-vitro diagnostic medical device intended for the qualitative detection of group "A" streptococcal antigen from throat swabs or confirmation of presumptive group "A" streptococcal colonies recovered from culture:
a) OSOM Strep A Test (Brand for Wyntek);
b) Signify Strep A Test (Brand for Abbott Labs.);
c) ACCEAVA Strep A Component-Test Sticks (Brand for Biostar).
CODE a) Product No. 141, Lot Nos. 7301, 7310; and Product No. 998, Lot No. 7310-10; b) Product No. 99-0347, Lot Nos. 59947M200, 59948M200, 59949M200, 59951M200, 61473M200 through 61476M200 c) Catalog No. ACCGAS-C Lot Nos. 017294, 017297, 017301, 017306, 017313, 017315; and Catalog No. ACCGAS10-C, Lot No. 017301-10.
MANUFACTURER Wyntek Diagnostics, Inc., San Diego, California.
DISTRIBUTION The OSOM product name was distributed Nationwide. The Signify brand was distributed solely to Abbott Laboratories, Abbott Park, Illinois. The Acceava brand was solely distributed to Biostar, Inc., Boulder, Colorado.
QUANTITY OSOM (50 count) 1,565 OSOM (10 count)     33SIGNIFY 20,435   ACCEAVA (50 count) 13,695    ACCEAVA (10 count) 250 were distributed.
REASON The devices may sporadically show color trace with the negative control, producing a false positive reading on an external negative control.

PRODUCT Blood Collection Reservoirs, indicated for use with patients undergoing cardiopulmonary bypass or autotransfusion procedures:a) Blood Collection Reservoirs, Models EL240 and EL2120
b) Cardiotomy Reservoirs, Models EL400, EL402, and EL404.
CODE All lots.
MANUFACTURER Medtronic Mexico, S. de R.L. de C.V., Tijuana, Mexico.
RECALLED BY Medtronic Perfusion Systems, Minneapolis, Minnesota
DISTRIBUTION Nationwide and international.
QUANTITY 380,477 units were distributed; firm estimated that 5,000 units remained on market at time of recall initiation.
REASON There are holes in some of the sterile packages.

PRODUCT Light Diagnostics Simulfluor HS/VZV immunofluorescence Assay, intended for the simultaneous detection and identification of herpes Simplex (HSV) 1 and 2 and Varicella-Zoster Virus (VZV) form patients with vesicular, oral, or skin lesions, using direct specimens and culture confirmation.
CODE Catalog #3295, Lot #19102679.
MANUFACTURER Chemicon International, Inc., Temecula, California.
RECALLED BY Light Diagnostics, Div. Chemicon International, Inc., Temecula, California
DISTRIBUTION Arizona, California, Connecticut, Florida, Kansas, Maryland, United Kingdom, Canada, Switzerland.
QUANTITY 12 kits were distributed.
REASON Labeling error - The primary reagent, labeled in part "SimuFlour HSV/VZV ***EXP 12/00" should bear the expiration date "02/01: as indicated on the box end label.

WEEK ENDING MARCH 31

PRODUCT Literature for BioSorb FX 2.0/2.4 Bioabsorbable Fixation System.
CODE Lot #1939.
MANUFACTURER Bionx Implants Ltd., Tampere, Finland.
RECALLED BY Bionx Implants, Inc., Blue Bell, Pennsylvania
DISTRIBUTION Canada, Australia, Latin America.
QUANTITY 2,550 units were distributed.
REASON Device is labeled for unintended use. Firm's sales literature misbrands the device for mandibular indications.

PRODUCT Implantable Cardiovascular Defibrillators, used to detect ventricular arrhythmias and deliver therapy for the detected arrhythmia. The devices are designed to treat ventricular fibrillation, ventricular tachycardia, and bradycardia: a) GEM II VR Single Chamber Implantable defibrillator, Model No. 7229CX; b) GEM II DR Dual Chamber Implantable Cardiovascular Defibrillator, Model No. 7273.
CODE Serial Numbers:
United States Distribution:
Model 7229CX: PJJ200000H, PJJ200001H, PJJ200002H, PJJ200021H, PJJ200024H, PJJ200025H,PJJ200026H, PJJ200027H - PJJ200034H, PJJ200035H, PJJ200036H, PJJ200037H, PJJ200039H and PJJ200040H. Model 7273: PJK200004H, PJK200005H, PJK200010H, JK200015H, PJK200071H - PJK200078H, PJK200108H, PJK200110H, JK200115H, PJK200116H, PJK200119H, PJK200121H, PJK200122H, PJK200124H - PJK200126H, PJK200138H, PJK200139H, PJK200141H, PJK200144H, PJK200147H, PJK200152H, PJK200154H - JK200158H, PJK200160H, PJK200161H, PJK200164H, PJK200167H, PJK200169H - PJK200172H, PJK200178H, PJK200190H - PJK200201H, PJK200203H, PJK200206H, PJK200207H, PJK200211H, PJK200212H, PJK200215H, PJK200217H, PJK200218H, PJK200220H, PJK200221H, PJK200224H, PJK200229H, PJK200268H, PJK200272H, PJK200274H, PJK200279H, PJK200283H - PJK200288H, PJK200294H, JK200296H, PJK200298H - PJK200300H, PJK200302H, PJK200303H, JK200307H, PJK200309H, PJK200311H, PJK200312H, PJK200315H, PJK200317H, PJK200319H, PJK200320H, PJK200323H, PJK200324H, PJK200326H - PJK200328H, PJK200335H, PJK200336H, PJK200338H, PJK200339H, PJK200341H, PJK200345H, PJK200348H, PJK200353H, PJK200354H - PJK200356H, PJK200360H, PJK200364H, JK200369H, PJK200371H, PJK200372H, PJK200381H - PJK200384H, JK200389H, PJK200391H, PJK200395H, PJK200398H, PJK200407H, PJK200408H, PJK200412H, PJK200414H, PJK200415H, PJK200421H, PJK200425H, PJK200427H, PJK200429H - PJK200433H, PJK200435H, JK200436H, PJK200438H, PJK200440H, PJK200441H, PJK200443H, PJK200444H, PJK200450H, PJK200451H, PJK200455H, PJK200458H - JK200461H, PJK200466H, PJK200469H - PJK200482H, PJK200484H, PJK200486H - PJK200489H, PJK200491H, PJK200493H - PJK200495H, PJK200497H, PJK200500H, PJK200502H - PJK200504H, JK200506H, PJK200508H, PJK200509H, PJK200512H - PJK200514H, JK200516H, PJK200518H, PJK200519H, PJK200521H, PJK200523H, PJK200524H, PJK200526H - PJK200537H, PJK200540H - PJK200542H, JK200544H - PJK200547H, PJK200549H, PJK200551H, PJK200555H, PJK200556H, PJK200558H, PJK200559H, PJK200565H - JK200568H, PJK200571H, PJK200572H, PJK200574H, PJK200576H, PJK200577H, PJK200580H, PJK200597H - PJK200599H, PJK200602H, JK200603H, PJK200609H, PJK200610H, PJK200616H, PJK200617H, PJK200618H - PJK200623H, PJK200626H, PJK200628H, JK200629H,PJK200630H, PJK200636H, PJK200656H - PJK200659H, PJK200660H - JK200668H, PJK200670H - PJK200678H, PJK200680H, PJK200682H - PJK200684H, PJK200686H, PJK200688H - PJK200700H, PJK200702H, PJK200703H, PJK200705H - PJK200710H PJK200712H, PJK200713H, PJK200715H, PJK200716H, PJK200718H, PJK200721H, PJK200724H, PJK200726H - PJK200728H, PJK200730H, PJK200732H - PJK200735H PJK200738H, PJK200741H, PJK200743H, PJK200745H - PJK200747H, PJK200757H - PJK200765H, PJK200768H - PJK200774H, PJK200776H, PJK200777H, PJK200779H - JK200781H, PJK200783H, PJK200784H, PJK200787H - PJK200789H, PJK200791H -PJK200796H, PJK200805H, PJK200809H - PJK200817H, PJK200819H - PJK200822H, PJK200826H, PJK200832H, PJK200840H - PJK200845H, PJK200847H - PJK200849H, PJK200851H, PJK200852H, PJK200856H, PJK200860H, PJK200861H, PJK200863H - PJK200869H, PJK200871H, PJK200872H, PJK200874H - PJK200880H, PJK200883H, PJK200884H, PJK200886H, PJK200889H, PJK200891H - PJK200897H, PJK200899H, PJK200900H - JK200907H, PJK200911H - PJK200913H, PJK200918H - JK200920H, PJK200923H, PJK200925H, PJK200926H, PJK200928H - JK200932H, PJK200937H, PJK200940H, PJK200942H, PJK200946H, PJK200948H, PJK200950H, PJK200952H, PJK200954H, PJK200956H - JK200958H, PJK200960H, PJK200963H - PJK200972H, PJK200974H - JK200977H, PJK200979H, PJK200981H - PJK200988H, PJK200991H, PJK200992H, PJK200994H - PJK200999H, PJK201001H, JK201002H, PJK201004H, PJK201005H, PJK201009H - PJK201015H, PJK201017H - PJK201019H, PJK201021H, PJK201023H, PJK201025H, PJK201026H, PJK201029H, PJK201030H, PJK201032H - JK201035H, PJK201037H, PJK201039H - PJK201041H, PJK201049H, JK201050H, PJK201052H, PJK201056H - PJK201061H, PJK201064H, JK201066H, PJK201071H - PJK201077H, PJK201080H, PJK201082H, PJK201084H - PJK201089H, PJK201091H, PJK201103H, PJK201106H, PJK201108H, PJK201117H - PJK201119H, PJK201121H, JK201122H, PJK201124H - PJK201128H, PJK201130H - PJK201132H, PJK201134H, PJK201135H, PJK201136H, PJK201142H - PJK201144H, PJK201146H, PJK201147H - PJK201149H, PJK201158H, PJK201161H, PJK201162H, PJK201165H, PJK201167H, PJK201168H, PJK201170H, PJK201174H, PJK201177H, PJK201180H, PJK201182H, PJK201183H, PJK201184H, PJK201185H, PJK201187H, PJK201189H - PJK201191H, PJK201194H - PJK201199H, PJK201202H, PJK201204H, PJK201205H, PJK201207H, PJK201208H, PJK201209H, PJK201211H, PJK201212H, PJK201213H, PJK201214H, PJK201215H, PJK201216H, PJK201217H, PJK201218H, PJK201219H, PJK201222H - PJK201224H, PJK201247H, PJK201248H - PJK201252H, PJK201254H, PJK201255H, PJK201259H, PJK201260H, PJK201262H - PJK201265H, PJK201268H, PJK201269H, PJK201272H - PJK201274H, PJK201277H - PJK201284H, PJK201289H - PJK201299H, PJK201301H - PJK201303H, PJK201305H, PJK201307H, PJK201310H, PJK201312H, PJK201314H, PJK201316H, PJK201317H, PJK201320H,
PJK201322H - PJK201325H, PJK201329H - PJK201331H, PJK201333H, PJK201334H, PJK201336H, PJK201338H - PJK201343H, PJK201345H, PJK201346H, PJK201350H - PJK201355H, PJK201357H, PJK201360H - PJK201363H, PJK201365H, PJK201367H - PJK201370H, PJK201372H - JK201375H, PJK201378H - PJK201380H, PJK201382H, PJK201384H, PJK201386H, PJK201387H, PJK201389H - PJK201391H, JK201394H,
PJK201395H, PJK201398H - PJK201400H, PJK201408H, JK201409H, PJK201411H, PJK201413H, PJK201414H, PJK201416H, PJK201419H, PJK201420H, PJK201422H, PJK201423H, PJK201425H, PJK201426H, PJK201428H - PJK201431H, PJK201434H, PJK201435H, PJK201437H, PJK201438H, PJK201443H - PJK201445H, PJK201448H - PJK201450H, PJK201452H, PJK201453H, PJK201454H, PJK201456H, PJK201458H,
PJK201459H, PJK201463H - PJK201469H, PJK201472H, PJK201474H, PJK201475H, PJK201480H, PJK201481H, PJK201494H, PJK201498H, PJK201499H, PJK201504H - PJK201506H, PJK201507H - PJK201510H, PJK201512H, PJK201513H, PJK201515H, PJK201517H, PJK201518H, PJK201521H - PJK201523H, PJK201525H - PJK201530H, PJK201534H, PJK201535H, PJK201537H - PJK201542H, PJK201544H - JK201549H,
PJK201551H - PJK201554H, PJK201557H, PJK201559H, PJK201595H, PJK201597H, PJK201601H, PJK201604H - PJK201607H, PJK201609H - PJK201614H, PJK201616H, PJK201620H, PJK201630H - PJK201639H, PJK201641H, PJK201642H, PJK201647H, PJK201648H, PJK201676H, PJK201677H, PJK201679H, PJK201680H, PJK201700H, PJK201702H - PJK201704H, PJK201710H - PJK201714H, PJK201720H, PJK201722H
- PJK201725H, PJK201727H - PJK201729H, PJK201731H, PJK201734H - PJK201736H, PJK201739H - PJK201742H, PJK201744H, PJK201745H, PJK201747H - PJK201755H, PJK201757H - PJK201761H, PJK201763H, PJK201764H, PJK201769H, PJK201770H, PJK201772H, PJK201774H, PJK201778H - PJK201780H, PJK201782H - PJK201789H, PJK201791H - PJK201793H, PJK201796H - PJK201800H, PJK201802H, PJK201809H, PJK201812H, PJK201813H, PJK201817H, PJK201818H, PJK201822H, PJK201823H, PJK201828H, PJK201829H, PJK201836H, PJK201839H, PJK201843H, PJK201844H, PJK201849H - PJK201851H, PJK201853H - PJK201858H, PJK201861H, PJK201864H - PJK201866H, PJK201869H - PJK201875H, PJK201877H, PJK201878H, PJK201880H - PJK201882H, PJK201889H, PJK201891H, PJK201892H, PJK201894H - PJK201897H, PJK201900H, PJK201901H, PJK201903H - PJK201906H, PJK201908H, PJK201910H, PJK201911H, PJK201914H, PJK201915H, PJK201917H, PJK201919H, PJK201921H, PJK201923H - PJK201926H, PJK201929H, PJK201930H, PJK201932H, PJK201933H - PJK201942H, PJK201945H, PJK201946H, PJK201948H, PJK201949H, PJK201951H, PJK201956H, PJK201960H, PJK201962H, PJK201964H, PJK201965H, PJK202079H - PJK202081H, PJK202164H - PJK202167H, PJK202169H, PJK202171H, PJK202172H, PJK202176H, PJK202177H, PJK202179H, PJK202181H, PJK202182H, PJK202186H, PJK202187H, PJK202189H - PJK202193H, PJK202195H - PJK202197H, PJK202199H, PJK202202H, PJK202203H - PJK202205H, PJK202208H, PJK200490H, PJK200604H, PJK200615H, PJK200687H, PJK200890H, PJK200980H, PJK201022H, PJK201053H, PJK201166H, PJK201246H, PJK201315H, PJK201366H, PJK201516H, PJK201628H, PJK201718H, PJK201762H, PJK201773H, PJK201920H, PJK202194H, PJK202754H, PJK203409H, PJK207051H, PJK207054H, PJK207056H - PJK207059H, PJK207063H, PJK200112H, PJK200118H, PJK200123H, PJK200153H, PJK200209H, PJK200280H, PJK200306H, PJK200410H, PJK200445H, PJK200485H, PJK200492H, PJK200501H, PJK200515H, PJK200520H, PJK200548H, PJK200612H, PJK200701H, PJK200711H, PJK200722H, PJK200725H, PJK200736H, PJK200753H, PJK200755H, PJK200782H, PJK200790H, PJK200888H, PJK200908H, PJK200910H, PJK200914H, PJK200915H, PJK200917H, PJK200922H, PJK200951H, PJK200959H, PJK200973H, PJK200978H, PJK201000H, PJK201024H, PJK201038H, PJK201044H, PJK201047H, PJK201094H, PJK201120H, PJK201129H, PJK201141H, PJK201159H, PJK201169H, PJK201173H, PJK201176H, PJK201186H, PJK201188H, PJK201193H, PJK201203H, PJK201206H, PJK201210H, PJK201221H, PJK201261H, PJK201287H, PJK201288H, PJK201337H, PJK201347H, PJK201349H, PJK201364H, PJK201376H, PJK201383H, PJK201388H, PJK201412H, PJK201415H, PJK201418H, PJK201421H, PJK201432H, PJK201433H, PJK201436H, PJK201441H, PJK201447H, PJK201455H, PJK201457H, PJK201462H, PJK201479H, PJK201490H, PJK201502H, PJK201511H, PJK201514H, PJK201519H, PJK201533H, PJK201536H, PJK201555H, PJK201558H, PJK201596H, PJK201603H, PJK201615H, PJK201654H, PJK201707H, PJK201719H, PJK201721H, PJK201733H, PJK201737H, PJK201756H, PJK201768H, PJK201790H, PJK201814H, PJK201848H, PJK201863H, PJK201868H, PJK201885H, PJK201898H, PJK201899H, PJK201902H, PJK201931H, PJK201963H, PJK202168H, PJK202175H, PJK202201H, PJK207050H and PJK207055H.
Distribution to Australia:
Model 7273: PJK200319S, PJK200320S, PJK200738S, PJK200740S, PJK201842H, PJK201909H, PJK201912H, PJK201916H, PJK201927H, PJK200399S, PJK200412S, and PJK200419S.
Distribution to Canada:
Model 7273: PJK200174H, PJK200214H, PJK200305S, PJK200310S, PJK200322S, PJK200323S, PJK200346S, PJK200520S, PJK200521S, PJK200522S, PJK200524S, PJK200526S, PJK200528S, PJK200606H, PJK200607H, PJK200611H, PJK200696S, PJK200743S, PJK200762S, PJK200768S, PJK200853H, PJK200857H, PJK200989H, PJK201815H, PJK201834H, PJK201835H, PJK201837H, PJK201838H, PJK201883H, PJK201922H, PJK202178H, PJK202209H, PJK200415S and PJK200424S.
Distribution to Europe:
Model 7229Cx: PJJ200038S, PJJ200040S, PJJ200045S, PJJ200077R, PJJ200078R, PJJ200079R, PJJ200080R, PJJ200082R - PJJ200088R, PJJ200090R - PJJ200092R, PJJ200094R - PJJ200098R, PJJ200100R - PJJ200104R, PJJ200106R, PJJ200107R, PJJ200109R, PJJ200110R - PJJ200116R, PJJ200118R - PJJ200120R, PJJ200124R - PJJ200126R, PJJ200128R - PJJ200133R, PJJ200135R - PJJ200138R, PJJ200162R, PJJ200164R - PJJ200166R, PJJ200168R, PJJ200170R - PJJ200172R, Model 7273: PJK100462R, PJK100467R, PJK100471R, PJK100476R - PJK100478R, PJK100545R - PJK100552R, PJK100554R, PJK100556R - PJK100558R, PJK100592R, PJK100593R, JK100595R, PJK100600R - PJK100603R, PJK100606R - PJK100608R, JK100612R - PJK100619R, PJK100625R - PJK100629R, PJK100632R, PJK100636R, PJK100640R, PJK100642R, PJK100643R, PJK100646R,
PJK100651R - PJK100653R, PJK100656R, PJK100657R, PJK100661R, PJK100663R - PJK100665R, PJK100669R, PJK100670R, PJK100672R, PJK100675R, PJK100677R - PJK100679R, PJK100681R, PJK100682R, PJK100684R, PJK100685R, PJK100687R - PJK100694R, PJK100718R - PJK100726R, PJK100729R - PJK100735R, PJK100737R, PJK200022R, PJK200023R, PJK200029R, PJK200031R, PJK200032R, PJK200036R - PJK200038R, PJK200040R, PJK200064S, PJK200066S, PJK200067S - PJK200070S, PJK200108S, PJK200109S, PJK200115S, PJK200124S,
PJK200126S, PJK200131S - PJK200134S, PJK200136S, PJK200173H, PJK200175H, PJK200204H, PJK200242S, PJK200254S, PJK200266H, PJK200267H, PJK200285S, PJK200287S - PJK200291S, PJK200293S, PJK200294S, PJK200296S, PJK200298S, PJK200300S, PJK200302S,
PJK200303S, PJK200313S, PJK200317S, PJK200344S, PJK200365S, PJK200367S, PJK200373S - PJK200376S, PJK200378S - PJK200380S, PJK200382S - PJK200388S, PJK200390S - PJK200393S, PJK200395S - PJK200398S, PJK200400S - PJK200404S, PJK200407S, PJK200409S, PJK200411S, PJK200413S, PJK200414S, PJK200416S - PJK200418S, PJK200420S - PJK200422S, PJK200423S, PJK200425S,PJK200427S, PJK200428S, PJK200513S - PJK200515S, PJK200519S, PJK200525H, PJK200529S, PJK200532S, PJK200533S, PJK200538H, PJK200539H,
PJK200597S - PJK200600S, PJK200603S - PJK200608S, PJK200610S - PJK200617S, PJK200619S, PJK200620S, PJK200622S, PJK200623S, PJK200624H, PJK200625H, PJK200625S, PJK200627H, PJK200627S, PJK200632S, PJK200634S, PJK200693S, PJK200695S, PJK200697S - PJK200699S, PJK200701S, PJK200702S, PJK200704S, PJK200706S - PJK200709S, PJK200712S, PJK200713S, PJK200715S - PJK200720S, PJK200723S, PJK200725S, PJK200728S - PJK200731S, PJK200731H, PJK200732S, PJK200733S, PJK200735S, PJK200736S, PJK200739H,
PJK200739S, PJK200741S, PJK200742H, PJK200742S, PJK200746S, PJK200748H, PJK200748S, PJK200750H - PJK200752H, PJK200756H,
PJK200757S, PJK200767S, PJK200772S, PJK200786H, PJK200797H, PJK200799H, PJK200801H, PJK200803H, PJK200804H, PJK200806H,
PJK200823H, PJK200824H, PJK200827H - PJK200831H, PJK200833H, PJK200835H - PJK200839H, PJK200881H, PJK200933H, PJK200934H, PJK200936H, PJK200938H, PJK200941H, PJK200943H, PJK200944H, PJK201065H, PJK201070H, PJK201078H, PJK201081H, PJK201138H, PJK201139H, PJK201145H, PJK201150H, PJK201152H, PJK201153H, PJK201154H, PJK201156H, PJK201157H, PJK201160H, PJK201164H,
PJK201171H, PJK201175H, PJK201300H, PJK201306H, PJK201309H, PJK201311H, PJK201313H, PJK201319H, PJK201335H, PJK201442H, PJK201470H, PJK201471H, PJK201492H, PJK201493H, PJK201500H, PJK201501H, PJK201503H, PJK201705H, PJK201706H, PJK201738H, PJK201808H, PJK201811H, PJK201816H, PJK201819H, PJK201821H, PJK201824H - PJK201827H, PJK201830H - PJK201833H, PJK201840H,
PJK201947H, PJK201950H, PJK201961H, PJK201966H and PJK201968H.
Distribution to Hong Kong:
Model 7273: PJK200249S, PJK200286S, PJK200679H, PJK200909H, PJK200945H, PJK201473H, PJK201820, PJK202206H, and PJK202207H.
MANUFACTURER Medtronic, Inc., Minneapolis, Minnesota; Medtronic Med Rel, Inc., Humacao, Puerto Rico; Medtronic, Switzerland Manufacturing Operations, Tolochenaz, Switzerland.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota
DISTRIBUTION Nationwide and international.
QUANTITY 1,628 defibrillators were distributed from December 1998 to November 1999.
REASON A fracture of a soldered connection in the devices could result in loss of telemetry and device output.

PRODUCT Various Heart Valves and Annuloplasty Rings:
a) St. Jude Medical Masters Series Rotatable Aortic Mechanical Heart Valve with Silzone Coating, Cuff Type, models:
Standard Polyester: 19AS-601, 21AS-601, 23AS-601, 25AS-601, 27AS-601, 29AS-601, 31AS-601. Expanded Polyester: 19AECS-602, 21AECS-602, 23AECS-602, 25AECS-602, 27AECS-602, 29AECS-602, 31AECS-602. Hemodynamic Plus Cuff: 17AHPS-605, 19AHPS-605, 21AHPS-605, 23AHPS-605, 25AHPS-605, 27AHPS-605. Expanded HP Cuff: 17AEHPS-605, 19AEHPS-605, 21AEHPS-605, 23AEHPS-605, 25AEHPS-605, 27AEHPS-605.
b) St. Jude Medical Masters Series Rotatable Mitral Mechanical Heart Valve with Silzone Coating, Cuff Type, models: Standard Expanded Polyester: 19MS-601, 21MS-601, 23MS-601, 25MS-601, 27MS-601, 29MS-601, 31MS-601, 33MS-601, 35MS-601, 37MS-601. Expanded Polyester: 19MECS-602, 21MECS-602, 23MECS-602, 25MECS-602, 27MECS-602, 29MECS-602, 31MECS-602, 33MECS-602. Hemodynamic Plus: 17MHPS-605, 19MHPS-605, 21MHPS-605, 23MHPS-605 25MHPS-605, 27MHPS-605. Expanded HP Cuff: 17MEHPS-605, 19MEHPS-605, 21MEHPS-605, 23MEHPS-605, 25MEHPS-605, 27MEPHS-605.
c) St. Jude Medical Regent Rotatable Aortic Mechanical Heart Valve with Standard Polyester Cuff Having Silzone Coating, models: 17-AG-701, 19-AG- 701, 21-AG-701, 23-AG-701, 25-AG-701, 27-AG-701, 29-AG-701;
d) St. Jude Medical Regent Rotatable Aortic Mechanical Heart Valve with Flex/Polyester Cuff Having Silzone Coating, models: 17AGF706, 19AGF706, 21AGF706, 23AGF706, 25AGF706, 27AGF706, 29AGF706;
e) St. Jude Medical Seguin Annuloplasty Ring for Mitral Valve Repair with Silzone Coating, models: SARS-M24, SARS-M26, SARS-M28, SARS-M30, SARS- M32, SARS-M34, SARS-M36, SARS-M38, SARS-M40;
f) St. Jude Medical Tailor Annuloplasty Ring with Silzone Coating, models: TAR-25, TAR-27, TAR-29, TAR-31, TAR-33, TAR-35;
g) St. Jude Medical Epic Porcine Aortic Bioprosthetic Heart Valve, models: ELS-21A, ELS-23A, ELS-25A, ELS-27A, ELS-29A, ELS-31A;
h) St. Jude Medical Epic Porcine Mitral Bioprosthetic Heart Valve, models: ELS-21M, ELS-23M, ELS-25M, ELS-27M, ELS-29M, ELS-31M.
CODE All serial numbers of SMJ valves and annulplasty rings with Silizone silver coating.
MANUFACTURER St. Jude Medical, Inc., St. Paul, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 47,283 mechanical heart valves, 963 Epic Porcine valves, and 3,083 annuloplasty rings were distributed.
REASON There is a statistically significant higher rate of paravalvular leaks with the silver ion (Silzone) coated sewing cuffs leading to valve
explants.

PRODUCT Alycon Analyzers, automated chemistry analyzers for in-vitro diagnostic use: a) Alycon Analyzer 300; b) Alycon Analyzer 300i.
CODE All codes.
MANUFACTURER Abbott Laboratories, Inc., Irving, Texas.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 535 analyzers distributed in the United States from 5/1/98 to 12/1/99.
REASON Software program errors cause incorrect association between patient and the patient results.

PRODUCT COBAS Integra Ammonia (NH3L) Cassettes, contains an in-vitro diagnostic reagent intended for use on COBAS Integra 400 and 700 for the quantitative determination of the ammonia concentration in plasma: a) Catalog #0766682; b) Catalog #0737453.
CODE Lot Numbers B2434 EXP 4/00 and B2635 EXP 5/00.
MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Lithium heparin plasma may give erratic results compared to EDTA plasma using the ammonia assay.

PRODUCT Ventak Prism Automatic Implantable Cardioverter Defibrillator, VR Models 1850 and 1855, and DR Models 1851 and 1856. These cardioverter defibrillators are intended for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias.
CODE Model 1850 Serial Numbers: 100027, 100028 - 100030, 100032, 100033, 100036, and 100039. Model 1851 Serial Numbers: 300129 - 300137, 300139 - 300143, 300156 - 300158, 300160 - 300162, 300164 - 300166, 300168 - 300171, 300173 - 300175, 300177, 300178, 300181 - 300190, 300192, 300194, 300195, 300197, 300199, 300201, 300204, 300205, 300207 -300209, 300213, 300216, 300218, 300222, 300224 - 300226, 300228, 300238, 300239, 300243, 300244, 300246 - 300249, 300251, 300252, 300254, 300255, 300261, 300262, 300264, 300266 - 300273, 300277, 300278, 300281, 300283, 300286, 300287, 300290, 300294, 300295, 300298, 300301 - 300306, 300308, 300311 - 300313, 300316, 300321, 300323 - 300326, 300330, 300331, 300336, 300339, 300341, 300343, 300344, 300348 - 300350, 300362, 300363, 300365, 300366, 300376 - 300379, 300381, 300385, 300386, 300388, 300393 - 300399, 300402 - 300405, 300407, 300408, 300410, 300413 - 300416, 300418, 300419, 300421, 300422, 300424, 300425,300427, 300428, 300429, 300430, 300432, 300437, 300439, 300442, 300448, 300449, 300452 - 300455, 300458, 300460, 300462 - 300469, 300472 - 300478, 300480, 300481, 300484 - 300492, 300494, 300498, 300500 - 300504, 300506 - 300509, 300511, 300512, 300515 - 300517, 300519, 300521, 300525,
300527, 300528, 300533 - 300536, 300542, 300548, 300550, 300551, 300553 - 300555, 300558, 300560, 300562, 300563, 300565 - 300567, 300570 - 300576, 300578 - 300583, 300619 - 300621, 300627, 300628, 300631, 300640, 300643, 300653, 300654, 300656, 300658, 300674, 300676, 300683, 300691, 300695, 300702, 300714, 300719, 300720, 300737, 300738, 300740, 300743, 300744, 300745, 300747, 300748, 300750 - 300752, 300773 - 300775, 300789, 300844, 300845, 300846, 300847, 300852, 300853, 300858, 300862, 300871, 300942, 300963, 301012, 301025, 301204, 301272, 301273, 301274, 301276, 301290, 301339, 301364, 301369, 301376, 301377, 301379, 301381, 301382, 301397, 301406, 301409 - 301411, 301417, 301418,
301420 - 301424, 301426, 301431 - 301433, 301445, 301452, 301454, 301459, 301482 - 301484, 301519, 301544, 301545, 301595, 301608,
301612, 301633, and 301694.
Model 1855 Serial Numbers: 500014, 500015, 500016, 500017, and 500018.
Model 1856 Serial Numbers: 600027, 600028, 600029, 600030, and 600031.
MANUFACTURER Guidant Corporation, St. Paul, Minnesota.
DISTRIBUTION Nationwide, Australia, Canada, Israel, New Zealand, Europe.
QUANTITY 364 units.
REASON Defect in an integrated circuit that can result in device failure.

PRODUCT Software for Pulmonary Function Testing System:
a) BreezePF v3.8 Software, Catalog No. 147536-003;
b) BreezePF v3.8A Software, Catalog No. 147570-003.
CODE None.
MANUFACTURER Medical Graphics Corporation, St. Paul, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 657 software disks were distributed.
REASON An anomaly has been discovered in the software that can cause confusion on the selection of which FEV1/FVC ratio is selected
for diagnostic reporting. The problem only occurs when using the Quality Review or Bronchial Provocation Review software to
select best composite efforts.

PRODUCT VDRL (Venteral Disease Research Laboratory) Test Kit-5.0 mL ampoule, slide test provides both qualitative and
semi-quantitative results.
CODE Part #600902, Lot #VDRLA-107 EXP 10/01.
MANUFACTURER Avanti Polar Lipids, Inc., Alabaster, Alabama.
DISTRIBUTION Minnesota.
QUANTITY 2 test kits.were distributed.
REASON The device was labeled with an incorrect expiration date.

PRODUCT Steri-Oss, HL Threaded Implant, HA Coated, endosseous dental implant: Part #5612HL, 5 mm x 12 mm; b) Part #4610HL,
4.5 mm x 10 mm.
CODE Lot Numbers: a) 302453 EXP 10/04; b) 302457 EXP 10/04.
MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California.
DISTRIBUTION Nationwide, Japan, Argentina, South Korea, Hong Kong.
QUANTITY a) 144 units; b) 26 units were distributed.
REASON Healing screws were mismatched between the two sizes during production assembly.
 
 
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS

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.
 

UPDATE

Bio-Laser Systems which appeared in the December 29, 1999 Enforcement is being updated to delete Model TUCO. The recall should read as follows:
PRODUCT Bio-Laser System, used for biostimulation:
a) Model 1000; b) Model 2000. Recall #Z-281/282-0.
CODE Bio-Laser Models 1000 and 2000.
MANUFACTURER Bio-Laser Response Corporation, Dr. Alvin Stjernholm, Lakewood, Colorado.
DISTRIBUTION Nationwide.
QUANTITY a) 18 models; b) 1 unit.
REASON The devices were distributed for human use without a 510(k) or PMA; and failed to comply with 21 CFR 1040.10 and 11 in that the models have numerous noncompliances.

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.