NOVEMBER 2000

WEEK ENDING NOVEMBER 3

PRODUCT Sigma 8000 Volumetric Infusion Pump with Version 3.29.00 Software.
CODE 792 serial numbers ranging from 00139 thru 58778. NOT all serial numbers within this range are affected.
MANUFACTURER Sigma International, Medina, New York.
DISTRIBUTION California, Georgia, Kansas, Michigan, Ohio, Pennsylvania, Wisconsin, Vermont.
QUANTITY 792 pumps were distributed.
REASON Devices have a software problem that can result in over or under infusion when the pump is stopped and the flow rate is changed without changing the Volume Limit (mL).

PRODUCT Vitros ImmunoDiagnostic Products FSH Calibrators, Catalog #190-1263, for in-vitro diagnostic use in the calibration of the Vitros Immunodiagnostic System for the quantative measurement of follicle stimulating hormone in human serum or plasma
CODE Lot Numbers: 80 EXP 8/15/00, 90 EXP 8/31/00, and 100 EXP 10/30/00.
MANUFACTURER Ortho-Clinical Diagnostic, Inc., Forest Farm Estate Whitchurch Cardiff, UK.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Alaska, Alabama, Arizona, Missouri, North Dakota, Washington state, Argentina, Australia, Belgium, Canada, Caribbean, Chile, France, Germany, India, Japan, Mexico, Netherlands, Norway, Panama, Poland, Portugal, Singapore, Spain, United Kingdom.
QUANTITY 644 packs were distributed.
REASON The calibration limits to place were too restrictive to accommodate the observed variability of the calibration process. This can prohibit users from running assays if the calibration failed.

PRODUCT Vitros ImmunoDiagnostic Products: a) Folate Calibrators, intended for in-vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of folate in human serum, plasma and whole blood; b) Range Verifiers, for in-vitro use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the quantitative measurement of folate in human serum, plasma, and whole blood.
CODE a) Catalog #131 1075, Lot Numbers: 50 EXP 3/27/00, 60 EXP 6/12/00, 70 EXP 8/4/00; b) Catalog #680 0873, Lot #3 EXP 8/12/00.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitechurch, Cardiff, UK.
RECALLED BY Ortho Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Nationwide, Australia, Canada, Caribbean, France, Italy, Belgium, Netherlands, Sweden, Norway, Denmark, Singapore, Spain.
QUANTITY a) 228 units; b) 66 units were distributed.
REASON Folate assays could not be calibrated. Folate was unstable.

PRODUCT a) Lyphochek Whole Blood Control Level I, Catalog #561; b) Lyphochek Whole Blood Metals Control Level 1, Catalog # 527, clinical chemistry (in-vitro diagnostic) control reagents intended to be used as an assayed quality control material to monitor precision of laboratory testing procedures for analytes listed in the package insert.
CODE Lot Numbers: a) 73051 EXP 7/31/01 and 73061 EXP 8/31/02; b) 36601 EXP 3/31/02.
MANUFACTURER Bio Rad Laboratories, Irvine, California.
DISTRIBUTION Nationwide, Australia, Canada, Colombia, Dominican Republic, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Singapore, Sweden, Taiwan, Thailand, United Kingdom.
QUANTITY a) 9,608 boxes; b) 67 boxes were distributed.
REASON The reconstituted stability claim of 3-days for the red blood cell folate is inaccurate.

PRODUCT Vitros DT Calibrator Kit, for in-vitro diagnostic use.
CODE Catalog #195 7927, Lot Numbers 76 and 81 EXP 30 JUN 99.
MANUFACTURER Ortho-Clinical Diagnostic, Inc., Rochester, New York.
DISTRIBUTION Nationwide and international.
QUANTITY 15,295 kits were distributed.
REASON Quality control results were low or outside expected range on DT CK slides.

WEEK ENDING NOVEMBER 10

PRODUCT Synchron LX ISE Reference Reagent, Part #467935, used in the measurement of electrolytes from patient samples.
CODE Lot #M004170 EXP 31 OCT 01.
MANUFACTURER Beckman Coulter, Inc., Carlsbad, California.
RECALLED BY Beckman Coulter, Inc., Brea, California
DISTRIBUTION Alabama, Arkansas, California, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Washington state, Australia, Canada, Italy, Mexico, Switzerland, England, France, Germany, Ireland, South Africa, Japan, Hong Kong, Taiwan, Sweden, Netherlands, Republic of Singapore, Spain, Puerto Rico.
QUANTITY 789 units were distributed.
REASON The C02 assay would not calibrate.

PRODUCT Vitros Eci Immunodiagnostic Estradiol Reagent Packs, Catalog #855 2360, for in vitro quantitative measurement of estradiol in human serum and plasma.
CODE Lot #134 EXP 07/03/00.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff, UK.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Connecticut, Indiana, Michigan, New York, Ohio, Texas, Utah, Argentina, Australia, Brazil, Canada, Chile, Colombia, England, Germany, India, Italy, Japan, Mexico, Puerto Rico, Panama, Singapore, Spain and Venezuela.
QUANTITY 938 kits were distributed.
REASON A positive bias was observed on controls and patient samples when using the above product.

PRODUCT Vitros Chemistry Products Testosterone Reagent, Catalog #143-5205, for in-vitro quantitative measurement of testosterone in human serum and plasma.
CODE Lot Numbers: 90 EXP 4 May 2000 Previous EXP 15 Oct 2000, Lot 100, Revised EXP 17 May 2000, Previous EXP 18 Oct 2000.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Cardiff, Wales, UK.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Nationwide, Argentina, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy and Spain.
QUANTITY 960 packs were distributed.
REASON Products were assigned the wrong expiration dates. EXP dates were too long.

PRODUCT Vitros Chemistry Products Vitamin B12 Reagent Pack, Catalog #145 3489, for in-vitro diagnostic use only for the quantitative measurement of vitamin B12 in human serum and plasma, to aid in the differential diagnosis of anemia.
CODE Lot Numbers 71 EXP 5/23/00 and Lot 80 EXP 8/26/00.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff, UK.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Nationwide, Argentina, Australia, Canada, England, France, Germany, Italy, Puerto Rico, Singapore and Spain.
QUANTITY 778 units were distributed.
REASON A positive bias was confirmed on patient samples.

PRODUCT Automated Slide Stainer (Dispenser), intended to stain samples collected to aid in the diagnosis of disease: a) Part #1362303; b) Part #1362304; c) Part #1362305.
CODE a) Part Number 1362303: A dispenser that is filled by Ventana Medical Systems and is used in the production of 87 different products with unique catalog numbers. Each of these products are for single use only and have no expiration dating except for that which applies to the reagent in the dispenser. 114,782 units of 119 dispenser lots are affected.
b) Part Number 1362304: An unfilled dispenser for customer use and is used in 62-65 other products. 8,167 units of 13 dispenser lots are affected.
c) Part Number 1362305: A dispenser for light sensitive reagents. it contains 36 reagents which are for single use and bear expiration dates relevant to the reagent. 19, 181 units of 22 dispenser lots are affected.
MANUFACTURER Ventana Medical Systems, Inc., Tucson, Arizona.
DISTRIBUTION Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Korea, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Panama, Philippines, Portugal, Scotland, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan ROC, Thailand, The Netherlands, Turkey, United Kingdom, Wales.
QUANTITY 269,498 kits were distributed.
REASON Leaking dispensers were attributed to the vent in the cap of the dispenser, the interface of the cap and the barrel or from the nozzle.

WEEK ENDING NOVEMBER 24

PRODUCT Hydrajust IV Urological Table.
CODE All Serial Numbers are affected for Part Numbers: 400001, 400002, 400005, 400006, 400007, 400008, 400011, 400012, 400015, 400016, and 400017. The Serial Numbers affected for Part Number 400025 are: 3496-0503, 3496-0504, 3596-0506, 3596-0507, 3896-0510, 4596-0512, 4796-0513, 4796-0514, 5196-0516, 5196-0517, 5196-0518, 5296-0519, 0397-0522, and 0397-0524. The Serial Numbers affected for Part Number 400026 are: 0797-0501, 1196-0502, 3496-0505, 3596-0508, 3996-0511, 4796-0515, 0297-0520, 0397-0521, and 0397-0523
MANUFACTURER Mallinckrodt, Inc., Liebel-Flarsheim Business, Cincinnati, Ohio.
RECALLED BY Mallinckrodt, Inc., Liebel-Flarsheim Business, Cincinnati, Ohio
DISTRIBUTION Nationwide and international.
QUANTITY 450 units were distributed.
REASON A mechanical failure may allow the table and tube arm to freely rotate downward and injure a patient.

PRODUCT Steri-Oss brand, Non-Hexed Cylindrical Implants (Endosseous Implants), HA Coated, 3.25D by 12mm, Catalog #2612H, decives that are surgically placed in the upper or lower jaw arches to provide support for a prosthetic device, such as artificial teeth and to restore the patients chewing function.
CODE Lot #993683.
MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California.
DISTRIBUTION California, Florida, Kentucky, Louisiana, Ohio, New Jersey, New York, Utah.
QUANTITY 59 units were distributed.
REASON Some of the inner vial labels were incorrectly placed on the 3.25 x 14mm implants, catalog #3214TPS, lot 993719.

PRODUCT ECG Electrodes intended for use during electrocardiographic procedures:
a) InvisaTrace 1680, Radiotranslucent Clear Tape ECG Electrode, sold as follows: Catatalog #1680-001, 1 per pouch, 30 per box, 600 per case Catatalog #1680-005, 5 per pouch, 50 per box, 600 per case, Cat. #1680-030, 30 per pouch, 600 per case;
b) UltraTrace 1690, Clear Tape ECG Electrode, multi-purpose for short or long term use. The product insert identifies this as an adult long-term monitoring electrode and describes long term use as 5-7 days. Sold as follows: Catalog #1690-001, 1 per pouch, 30 per box, 600 per case, Catalog #1690-003, 3 per pouch, 30 per box, 600 per case, Catalog #1690-005, 5 per pouch, 30 per box, 600 per case, Catalog #1690-010, 10 per pouch, 50 per box, 1000 per case, Cat. #1690-030, 30 per pouch, 600 per case.
CODE a) InvisaTrace Model No. 1680 Series, Radiotranslucent Clear Tape ECG Electrode; Catalog No. 1680-001, Lot Codes 9909211, 9910071, 9910081; Catalog No. 1680-005, Lot Codes 9909181, 9909231, 9910081; Catalog No. 1680-030, Lot Codes 9909231, 9909232, 9909271, 9909272, 9909291, 9909292, 9910011, 9910012, 9910052, 9910061, 9910082, 9910131;
b) UltraTrace Model 1690 Series, Clear Tape ECG Electrode, Catalog No. 1690-001, Lot Codes 9909301, 9910261, 9910262; Catalog No. 1690-003, Lot Codes 9909201, 9909202, 9911011; Catalog No. 1690-005, Lot Codes 9909131, 9910121, 9910122, 9910132, 9910141, 9910142, 9910192, 9910221; Catalog No. 1690-010, Lot Codes 9909071, 9910051, 9909211, 9909231, 9909241, 9910261, 9910262, 9910291; Catalog No. 1690-030, Lot Codes 9909141, 9909141, 9909152, 9909161, 9909252, 9909291, 9910041, 9910052, 9910071, 9910081, 9910151, 9910202, 9910262, 9910271, 9911031, 9911041.
MANUFACTURER Conmed Corporation, Rome, New York.
RECALLED BY Conmed Corporation, Utica, New York
DISTRIBUTION Nationwide, Australia, Canada, Germany, Japan, The Netherlands, Spain, Taiwan.
QUANTITY a) 737 cases; b) 1,911 cases.
REASON Some electrodes in these lots may exhibit a separation of the sensing element from the body of the electrode, causing the electrode not to function.

PRODUCT Escort E300 Series Patient Monitor, intended use is as an electrocardiograph and respiration monitor.
CODE Serial numbers are non-sequential (there are gaps), are four digits long and include: 1001 to 4086.
MANUFACTURER Medical Data Electronics, Arleta, California.
DISTRIBUTION Nationwide, Belgium, Canada, Czech Republic, England, Finland, France, Greece, Hong Kong, India, Italy, Korea, Kuwait, Netherlands, Norway, Russia, South Africa, Sweden, Switzerland, Taiwan, ROC, Turkey, United Arab Emirates, United Kingdom.
QUANTITY 483 units were distributed.
REASON It is possible for the High Breath Rate Alarm to function incorrectly under certain conditions.

PRODUCT Pulse Generators, intended for the treatment of Bradycarcdia:
a) META DDR, Model No. 1256D Pulse Generator;
b) TEMPO VR, Model No. 1102 Pulse Generator;
c) TEMPO V, Model No. 1902 Pulse Generator;
d) TEMPO DR, Model No. 2102 Pulse Generator;
e) TEMPO D, Model No. 2902 Pulse Generator.
CODE Serial numbers from U6100663 to U6227334.
MANUFACTURER Teletronics Pacing Systems, Miami Lakes, Florida.
RECALLED BY St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California.
DISTRIBUTION Nationwide and international.
QUANTITY 10,345 devices were distributed.
REASON Dendritic growth at the battery/hybrid connection could cause a short circuit, which in turn could result in premature battery depletion.

PRODUCT Thoracentesis/Paracentesis Kits (Sterile), Catalog #TPK1001, intended use is to perform Thoracemtesis and Paracemtesis procedures using a needle to remove thoracic fluid.
CODE Lot #L0B070.
MANUFACTURER Allegiance Healthcare Corporation, El Paso, Texas.
DISTRIBUTION Nationwide.
QUANTITY 156 kits were distributed.
REASON Unsterilized kits labeled as sterile.

PRODUCT CryoValve Allograft, human heart valve replacement implant.
CODE
Model Number AV00 - Serial Number 3832821;
Model Number PV00 - Serial Number 3832848;
Model Number PV00 - Serial Number 3978893;
Model Number AV00 - Serial Number 6011365;
Model Number PV00 - Serial Number 6011373.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Pennsylvania, Texas, Maryland, California, Kentucky.
QUANTITY 5 valves were distributed.
REASON Donors did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids.

PRODUCT Custom Procedure Trays, for use in cardiopumonary bypass.
CODE All lot numbers. All products produced in the Junior Tray Configuration which has been in production since January 1999.
MANUFACTURER Edwards Life Science L.L.C., Irvine, California.
DISTRIBUTION Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kentucky, Maryland Michigan, Missouri, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington state, District of Columbia.
QUANTITY Firm estimates none remains on the market.
REASON The sterility of the product cannot be assured due to reports of some open seals.

PRODUCT a) SDL-FL-10/20 Series Fiber Laser; b) SDL-FD-25 Fiber Coupled Laser Systems, diode laser systems used as laser marking systems.
CODE Model SDL-FL10/20 and SDL-FD25.
MANUFACTURER SDL Inc., San Jose, California.
DISTRIBUTION Nationwide and international.
QUANTITY a) 293 units; b) 40 units were distributed.
REASON The laser product failed to comply with the Federal laser product performance standard, 21 CFR 10 40.10(f)(4). The key could be removed from the key control of the laser systems when the key was in the "On" position.

PRODUCT Various models of SSCOR powered suction pumps used exclusively by professional personnel trained in the techniques of constant suctioning to clear the airway by removing bodily fluids and articulate matter:
a) Suction Unit, Model No. 10552;
b) Suction Unit, Model No. 15002;
c) Suction Unit, Model No. 2500;
d) Suction Unit, Model No. 40014;
e) Suction Unit, Model No. 45000;
f) Suction Unit, Model No. 64000;
g) Suction Unit, Model No. 64000-220;
h) Suction Unit, Model No. 90024;
i) Suction Unit, Model No. 90032.
CODE a) Serial Nos. 2655 - 3152; b) Serial Nos. 628 - 3603; c) Serial Nos. 250 - 887; d) Serial Nos. 5802 - 6499; e) Serial Nos. 1094 - 1142;
f) Serial Nos. 4881 - 8381; g) Serial Nos. 1008 - 1128; h) Serial Nos. 1854 - 2290; i) Serial Nos. 2216 - 2388.
MANUFACTURER SSCOR, Inc., Sun Valley, California.
DISTRIBUTION Nationwide, Mexico, Canada, Philippines, Chile.
QUANTITY 6,354 units were distributed.
REASON Presence of hairline cracks in the plastic fuse holders which house a fuse required to recharge the suction unit.

PRODUCT Cardiac T Rapid Assay, Catalog #5740200, intended for use in the qualitative determination of cardiac troponin T in anticoagulated venous or arterial whole blood.
CODE All lot numbers.
MANUFACTUER Roche Diagnostics, GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Sodium fluoride interferes with the assay and results in falsely low values.

PRODUCT a) Cardiac M Assay, Catalog #1893840, intended for use with the cardiac reader analyzer to provide rapid and quantitative measurements of cardiac troponin T; b) Cardiac T Quantitative Assay, Catalog #1894307, for use with the cardiac reader analyzer to provide rapid and quantitative measurements of cardiac troponin T.
CODE All lots.
MANUFACTURER Roche Diagnostics, GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Massachusetts.
QUANTITY Undetermined.
REASON The use of blood collection devices containing sodium fluoride cause falsely low results.

PRODUCT a) Precical, Catalog Nos. 620213 and 917213, a lyophilized preparation of pooled human sera for use as a calibrator of clinical chemistry assays; b) Precitrol A, Catalog Nos. 620211 and 917211; c) Precitrol N, Catalog Nos. 620212 and 917212, lyophilized preparations of pooled human sera for use as a control of clinical chemistry assays.
CODE Lot Numbers: a) 750001 and 750002; b) 770001, 770002, and 770003; c) 760001, 760002, and 760003.
MANUFACTURER Roche Diagnostics Corporation, Indianapolis, Indiana.
DISTRIBUTION Nationwide.
QUANTITY 58,086 Precial and 878,692 Precitrol A and N.
REASON A negative bias was observed when using the calcium setpoint associated with these lots of calibrators.