December 31, 1997 97-53 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Coumadin Tablets (Warfarin Sodium), 3 mg, in hospital unit dose cards packed 10 tablets per card, 10 cards per box, an Rx anticoagulant, labeled for hospital use only. NDC #0056-0188-75. Recall D-033-8. CODE Lot #LH354A. MANUFACTURER Dupont Merck Pharma, Manati, Puerto Rico. RECALLED BY DuPont Merck Pharmaceutical Company, Garden City, New York, by letter faxed on October 15., 1997 and mailed on October 16, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,476 units were distributed; firm estimated that less than 1,238 units remained on market at time of recall initiation. REASON Labeling -- Incorrectly declared strength-some 3 mg units labeled as containing 8 mg or 9 mg tablets. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III=========== _______________ PRODUCT Coumadin Tablets (Warfarin Sodium, USP), 5 mg, in hospital unit dose cards, packed 10 tablets per card, 10 cards per box, Rx anticoagulant. NDC #0056-0172-75. Recall #D-056-8. CODE Lot numbers: Lots: LF269A (exp. date 6/2000); LE199B (exp.date 05/2000); LF340A (exp. date 6/2000). MANUFACTURER DuPont Merck Pharmaceutical Company, Garden City, New York. RECALLED BY Manufacturer, by letter on November 5, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Venezuela, Barbados, Colombia. QUANTITY 21,630 units of lot LF269A; 17,029 units of lot LE199B; and 2,476 units of lot LF340A were distributed. REASON Mislabeling - Incorrectly declared strength- Some 5 mg units labeled as containing 6 mg tablets. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT a) Red Blood Cells; b) Red Blood Cells-Leukocytes Removed; c) Fresh Frozen Plasma. Recall #B-254/256-8. CODE Unit numbers: a) 10489-4475; b) 10505-8490 c) 10489-4475. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 31, 1996. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from donors which tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-I), but were collected from donors who previously tested repeatedly reactive for anti-HTLV-I, on two occasions. _______________ PRODUCT Platelets, pheresis. Recall #B-335-8. CODE Unit #4172041. MANUFACTURER Central Texas Regional Blood & Tissue Center, Austin, Texas. RECALLED BY Manufacturer, by letter dated November 11, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product had a platelet yield above the acceptable limit. _______________ PRODUCT Red Blood Cells. Recall #B-337-8. CODE Unit #03FQ07362. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated April 16, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-366-8. CODE Unit numbers: 009Q27140, 009Q27289, 009K86446, 009GN30451. MANUFACTURER American Red Cross Blood Services, Omaha, Nebraska. RECALLED BY Manufacturer, by telephone on April 28, 1997. Firm-initiated recall complete. DISTRIBUTION Nebraska. QUANTITY 4 units were distributed. REASON Blood products, which were exposed to unacceptable storage temperatures. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-381/383-8. CODE Unit #03GM26760. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated September 5, 1997, and by telephone on September 2, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose spouse has a history of hepatitis C. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-384/385-8. CODE Unit #03FX06294. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on April 8, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood products, corresponding to a unit of Fresh Frozen Plasma which was positive for coagulase negative Staphylococcus. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-386/387-8. CODE Unit #H11737. MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois. RECALLED BY Manufacturer, by telephone on October 16, 1997, and by letter dated October 16, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Platelets, Pheresis. Recall #B-388-8. CODE Unit #40P55993. MANUFACTURER American Red Cross, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on December 2, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product tested negative for CMV, but was collected from a donor who previously tested CMV positive. _______________ PRODUCT Red Blood Cells. Recall #B-389-8. CODE Unit #09FH03275. MANUFACTURER American Red Cross Blood Services, Omaha, Nebraska. RECALLED BY Manufacturer, by letter dated May 19, 1997. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Zovirax. _______________ PRODUCT Platelets, Pheresis. Recall #B-390-8. CODE Unit numbers: 09P54256, 09P54935, 09P55309. MANUFACTURER American Red Cross Blood Services, Omaha, Nebraska. RECALLED BY Manufacturer, by telephone on November 15 and 18, 1996, and by letter dated November 19, 1996. Firm-initiated recall complete. DISTRIBUTION Utah and Nebraska. QUANTITY 3 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-391-8. CODE Unit #1382514. MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky. RECALLED BY Manufacturer, by letter on November 11, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Recovered Plasma. Recall #B-394-8. CODE Unit #1384156. MANUFACTURER Central Texas Regional Blood & Tissue Center, Austin, Texas. RECALLED BY Manufacturer, by telephone on July 24, 1997, and by letter dated August 21, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was untested for Hepatitis B surface antigen (HBsAg), and the antibodies to the human immunodeficiency virus type 1/2 (anti-HIV-1/2), Hepatitis C virus encoded antigen (anti-HCV), Hepatitis B core antigen (anti-HBc), and syphilis. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-397/399-8. CODE Unit #42G04937. MANUFACTURER American Red Cross Blood Services, Cleveland Ohio. RECALLED BY Manufacturer, by letter dated November 5, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Methotrexate. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Recovered Plasma. Recall #B-257-8. CODE Unit #10505-8490. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 31, 1996. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit was distributed. REASON Blood product was collected from donors which tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-I), but were collected from donors who previously tested repeatedly reactive for anti-HTLV-I, on two occasions. _______________ PRODUCT Red Blood Cells. Recall #B-336-8. CODE Unit numbers: 11006187, 12003294, 12003296, 13000891, 31009637, 31009654, 31009672, 32005805. MANUFACTURER W.E. & Lela I. Stewart Blood Center, Inc., Tyler, Texas. RECALLED BY Manufacturer, by telephone on July 23, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 8 units were distributed. REASON Blood product were irradiated and labeled with an extended expiration date. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Supreme II Blood glucose Meter, Part #S2005, intended for the in-vitro measuring of the glucose level in whole blood. Recall #Z-203-8. CODE All serial numbers less than 2100035601. MANUFACTURER Applied Sciences Corporation, Hsinchu City, Taiwan R.O.C. RECALLED BY Chronimed, Inc., Minnetonka, Minnesota, by letter on November 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 20,146 units were distributed. REASON If this device is in the "plasma" mode and the actual blood glucose level is 575 mg/dL or higher, the device will display abnormally low glucose readings. _______________ PRODUCT Carlens (Y) Adapter Component to Tube Kits and Connector pack: a) U.S. Cat. No. 9589X and Intl Cat. No. 125-XX Left Hand Broncho-Cath Tube; b) U.S. Cat. No. 8588X and Intl Cat. No. 126-XX Right Hand Broncho-Cath Tube; c) U.S. Cat. No. 9587X and Intl Cat. No. 125-XX -1 Left Hand Broncho Cath Tube with Cardinal Hook; d) Intl. Cat. No. 125-10 Broncho-Cath Connector Pack. Recall #Z-223/226-8. CODE a) Broncho-Cath Endobronchial Tube, Left U.S. Cat. No. Lot No. 95890 1997-02 5084 95890 1997-04 5617 95891 1997-04 5578 95892 1997-03 5256 95892 1997-03 5581 95892 1997-04 5662 95893 1997-03 5235 95893 1997-03 5244 95893 1997-03 5254 95893 1997-03 5265 95893 1997-03 5590 95893 1997-04 5266 95893 1997-04 5603 95893 1997-04 5610 95893 1997-04 5619 95893 1997-04 5633 95894 1997-02 5234 95894 1997-03 5257 95894 1997-03 5583 95894 1997-03 5584 95894 1997-04 5612 95894 1997-04 5627 95894 1997-04 5657 95895 1997-02 5081 95895 1997-03 5263 95895 1997-04 5598 International Cat. No. Lot No. 125-28 1997-02 5233 125-28 1997-04 5577 125-28 1997-04 5616 125-32 1997-03 5248 125-32 1997-04 5579 125-35 1997-02 5069 125-35 1997-02 5228 125-35 1997-03 5249 125-35 1997-03 5255 125-35 1997-03 5580 125-35 1997-04 5634 125-37 1997-03 5227 125-37 1997-03 5229 125-37 1997-03 5230 125-37 1997-03 5250 125-37 1997-04 5251 125-37 1997-04 5613 125-37 1997-04 5652 125-39 1997-02 5232 125-39 1997-03 5226 125-39 1997-03 5258 125-39 1997-03 5259 125-39 1997-04 5628 125-41 1997-03 5238 125-41 1997-04 5654 b) Broncho-Cath Endobronchial Tube, Right U.S. Cat. No. Lot No. 85885 1997-03 4169 85887 1997-02 4757 85887 1997-04 5601 85888 1997-03 4723 85888 1997-04 5243 International Cat. No. Lot No. 126-35 1997-03 4725 126-35 1997-03 5240 126-35 1997-04 4711 126-37 1997-03 5241 126-37 1997-03 5267 126-39 1997-03 5242 126-39 1997-04 5268 126-41 1997-03 4729 126-41 1997-03 5587 c) Broncho-Cath Endobronchial Tube, Left with Carinal Hook U.S. Cat. No. Lot No. 95872 1997-04 5608 95873 1997-03 5245 95873 1997-04 5609 95874 1997-04 5246 95874 1997-04 5626 95875 1997-04 5236 International Lot No. Lot No. 125-37-1 1997-03 4108 125-37-1 1997-04 5252 125-39-1 1997-03 4720 125-39-1 1997-03 4754 125-41-1 1997-04 4185 d) Broncho-Cath Connector pack assembly (not distributed in the U.S) International Lot No. Lot No. 125-10 1997-04 5478. MANUFACTURER Mallinckrodt medical, Athlone, Ireland. RECALLED BY Mallinckrodt, Inc., Chesterfield, Missouri, by letters issued on October 17 and 23, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY Approximately 56,550 adapters were distributed. REASON The Carlens (Y) Adapter component may have a small flap (flash) of excess plastic in one of the ports where the smaller diameter tube joins the connector, which can partially occlude the inner diameter, causing some blockage of medical gas to occur. _______________ PRODUCT VENTAK R AV AICD Automatic Implantable Cardioverter Defibrillator, Models 1810 & 1815. Recall #Z-242/243-8. CODE All serial numbers. MANUFACTURER Guidant Corporation, Cardiac Pacemakers, Inc. (CPI), Minneapolis, Minnesota. RECALLED BY Manufacturer, by letter dated December 8, 1997. Firm-initiated recall ongoing. Firms Action is a field correction durning which the defibrillators are being reprogramed. None of the defibrillators are being returned or explanted. DISTRIBUTION Nationwide and international. QUANTITY 3,770 units were distributed. REASON A rare combination of device programming settings and clinical patient circumstances create the potential for the device to inappropriately deliver brief periods of pacing at 190 beats per minute. _______________ PRODUCT Ausonics OPUS 2 Realtime Ultrasound System, a ultrasound Scanner: a) Model: COMPACT, product part number 040-170 b) Model: COMPACT, product part number 040-020. Recall #Z-244/245-8. CODE The affected serial numbers are: A261412, A261712, A261812, A262012, 262112, A262412, A262712, A263012, A263112, A263212 A263312, A263412, A263512, A270101, A270201, A270401, A571501, A571701, A571801, A572001, A572201, A572401, A572501, A572601, A572701, A572801, A572605, A572901, A573203, A573303, A573603, A573803 D570105, D570106, D570110, D570205, D570206, D570209, D570210, D570305, D570309, D570310, D570405, D570406, D570409, D570506, D570510, D570605, D570606, D570705, D570706, D570708, D570710, D570805, D570806, D570808, D570809, D570906, D570908, D570909, D571005, D571006, D571009, D571109, D571209, D571210, D571308, D571405, D571408, D571508, D571509, D571605, D571608, D571609, D571709, D571710, D571805, D571905, D571908, D571910, D572105, D572110, D572205, D572208, D572305, D572306, D572405, D572408, D572409, D572505, D572508, D572509, D572510, D572609, D572709, D573001, D671005. MANUFACTURER Diasonics Ultrasound, Inc., Santa Clara, California. RECALLED BY Manufacturer, by letter faxed beginning on November 7, 1997, and by mail on November 26, 1997. Firm-initiated recall ongoing. DISTRIBUTION Florida, Indiana, Iowa, Louisiana, Maryland, New Mexico, New York, Texas, international. QUANTITY 91 units were distributed. REASON During VCR playback, the probe membrane surface temperature has the potential to exceed the published FDA temperature limit of 41C. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT INNOFLUOR Digitoxin Calibrator Set, Catalog No. 41051, intended for monitoring digitoxin levels in patients. Recall #Z-248-8. CODE Lot No. 26216. MANUFACTURER Oxis International, Inc., Portland, Oregon. RECALLED BY Manufacturer, by fax on November 14, 1997. Firm-initiated recall ongoing. DISTRIBUTION France, Belgium, Austria. QUANTITY 10 sets were distributed. REASON The device may not perform according to specifications during the labeled shelf life. #### END OF ENFORCEMENT REPORT FOR DECEMBER 31, 1997. BLANK PAGES MAY FOLLOW.End of Enforcement Report for