March 18, 1998 98-11 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============ _______________ PRODUCT Pumpkin Butter in glass jars, under the following brand names: "AMISH PUMPKIN BUTTER, HOME-MADE STYLE", Packaged by Miller's Orchard Nappanee, Indiana labeled as 8 oz. and 16 oz. "Die Bock Kich Bakery PUMPKIN BUTTER" labeled as 8 oz. and 1 Pint, Distributed by Das Dutchman Essenhaus Amish Country Kitchen 240 U.S. 20 Middlebury, Indiana 46540 "HOME-STYLE 'PUMPKIN PIE IN A JAR' PUMPKIN BETTER The Better Butter", labeled as 8 oz. and 15.5 oz., Shelton Farms, Niles, Michigan. Recall #F-279-8. CODE None. MANUACTURER Miller's Orchard, Inc., Nappanee, Indiana. RECALLED BY Manufacturer, by telephone on January 12-14, 1998. Firm-initiated recall ongoing. DISTRIBUTION Arizona, California, Indiana, Michigan, New York, Ohio. QUANTITY 1,247 cases (12 jars per case) were distributed. REASON The product had been manufactured and processed without the firm having filed scheduled process for the product, without a thermal process (open kettle processing was used with a hot pack), and in a plant unregistered with FDA by personnel who had not attended a Better Process Control School or its equivalent. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============ _______________ PRODUCT Bayer, Trasylol (Aprotinin Injection) Sterile Solution, 10,000 K.I.I./mL (1.4 mg/mL), Single Dose Vial, 100ml, NDC 0026-8196-36, 200ml, NDC 0026-8197-63, Rx indicated for prophylactic use to reduce perioperative blood loss and the need for a blood transfusion in patients undergoing cardiopulmonary bypass in the course of repeat coronary artery bypass graft surgery. Recall #D-099-8. CODE 100ml vials Lot# 7JAB, EXP 6/99 100ml vials Lot# 7LAC, EXP 6/99 200ml vials Lot# 7JFB, EXP 7/99. MANUFACTURER Bayer AG, Leverkusen, Germany. RECALLED BY Bayer Pharmaceutical Division, West Haven, Connecticut (labeler), by letter dated February 26, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY US Lot # 7JAB (Bayer Germany 965863K) 13,980 Vials released 11/21/97. US Lot # 7LAC (Bayer Germany 965863K) 15,942 Vials released 1/9/98. US Lot # 7JFB (Bayer Germany 967050E) 8,436 Vials released 11/24/97. REASON Foreign particulate - One vial was found to contain a birch tree seed. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III =========== _______________ PRODUCT Sufentanil Citrate Injection, USP, 50 mcg/mL sufentanil, in 2 and 5 mL ampules, 10 ampules per box, Rx, indicated for IV administration as an analgesic adjunct in patients who are intubated and ventilated, as a primary anesthetic agent for the induction and maintenance of anesthesia in patients undergoing major surgical procedures, and for epidural administration as an analgesic combined with low dose bupivacaine during labor and vaginal delivery, under the ESI (Elkins-Sinn) and VHA Plus labels. Recall #D-098-8. CODE Lot 016077 EXP 1/98 - NDC 0641-5143-33 Lot 016103 EXP 1-98 - NDC 0641-1143-33 Lot 016115 EXP 1/98 - NDC 0641-5142-33. MANUFACTURER Wyeth-Ayerst/ESI/Lederle Laboratories, Cherry Hill, New Jersey, a subsidiary of the American Home Products Corporation. RECALLED BY Manufacturer, by letter on July 14, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 4,807 boxes (10 ampules per box) were distributed. REASON Product contaminated with the preservative methylparaben. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======== _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-448/449-8. CODE Unit #29GM34115. MANUFACTURER American Red Cross, Greenville, North Carolina. RECALLED BY American Red Cross Blood Services, Norfolk, Virginia, by letter dated May 21, 1996, and by fax on May 17, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-654/655-8. CODE Unit #53M09259. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated November 5, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland and Pennsylvania. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western Blot indeterminate. _______________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF c) Recovered Human Serum; d) Recovered Plasma. Recall #B-671/674-8. CODE Unit numbers: a) 31H93392, 31G07008, 31R55310 b) 31H93392 and 31G07008. c) 31H93392 and 31G07008 d) 31H93392, 31G07008, and 31R55310 MANUFACTURER American Red Cross Blood Services, Buffalo, New York. RECALLED BY American Red Cross Blood Services, Rochester, New York, letter dated August 26, 1997. Firm-initiated recall complete. DISTRIBUTION New York, Massachusetts, California. QUANTITY a) 3 units; b) 2 units; c) 2 units; d) 3 units were distributed. REASON Blood products tested negative for the hepatitis B surface antigen (HBsAg), but were collected from donors who previously tested repeatedly reactive for HBsAg. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pooled. Recall #B-675/677-8. CODE Unit numbers: a) 4735003, 4766325, 4813867; b) 4735003; c) 4713812. MANUFACTURER BloodCare, Dallas, Texas. RECALLED BY Manufacturer, by letter dated May 6, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY a) 3 units; b) 1 unit; c) 1 unit was distributed. REASON Blood products were collected from a donor who traveled to a area considered endemic for malaria. _______________ PRODUCT Platelets. Recall #B-678-8. CODE Unit numbers: 12429-0432, 12429-0431, 12429-0424, 12429-0423. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 2, 1998. Firm-initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 4 units were distributed. REASON Blood products were prepared from units of Whole Blood which were shipped at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-681-8. CODE Unit #24KE16456. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated December 2, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was stored at an unacceptable temperature. _______________ PRODUCT Platelets, Pheresis. Recall #B-682-8. CODE Unit #49P36498. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on October 27, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product which tested positive for CMV antibody, was labeled as negative for CMV. _______________ PRODUCT Red Blood Cells. Recall #B-683-8. CODE Unit #GW27208. MANUFACTURER Metropolitan Washington Blood Bank, Bethesda, Maryland. RECALLED BY Manufacturer, by letter dated March 1, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but was collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. _______________ PRODUCT Red Blood Cells. Recall #B-684-8. CODE Unit #1432581. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by telephone on October 30, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receipt of post donation information indicating that the donor was in a high risk category. _______________ PRODUCT a) Whole Blood; b) Red Blood Cells; c) Platelets; d) Cryoprecipitated AHF; e) Recovered Plasma; f) Platelets, for further manufacture; g) Buffy Coat. Recall #B-686/692-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated July 28, 1997 or by fax on July 22, 1997, followed by letter dated September 22, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland, Virginia, District of Columbia, New Jersey, Massachusetts, Pennsylvania, California, North Carolina, New York, Switzerland. QUANTITY a) 1 unit; b) 31 units; c) 13 units; d) 3 units; e) 29 units; f) 1 unit; g) 1 unit was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, and was incorrectly reentered. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-694/695-8. CODE Unit numbers: a)01Q11541, 01T18359; b) 01Q11541. MANUFACTURER American Red Cross Blood Services, Rochester, New York. RECALLED BY Manufacturer, by letter dated February 7 or 17, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois, New York, Massachusetts. QUANTITY a) 2 units; b) 1 unit was distributed. REASON Blood products were collected from donors who reported travel to areas designated as endemic for malaria. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-696/697-8. CODE Unit #12416-5449. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter or fax dated July 31, 1996. Firm-initiated recall complete. DISTRIBUTION New Mexico and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had body piercing within twelve months of donation. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-698/699-8. CODE Unit #21GV00620. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letters on January 28 and 29, 1998. Firm-initiated recall complete. DISTRIBUTION Oregon and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-700-8. CODE Unit numbers 21GH89244 and 21GJ84044. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated February 2, 1998. Firm-initiated recall complete. DISTRIBUTION Oregon and California. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======= _______________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-648-8. CODE Unit #038FC28677. MANUFACTURER American Red Cross Great Lakes Region, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter dated October 3, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had no hemoglobin check recorded during screening. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-679/680-8. CODE Unit #GW26850. MANUFACTURER Metropolitan Washington Blood Bank, Bethesda, Maryland. RECALLED BY Manufacturer, by telephone on February 13, 1997. Firm-initiated recall complete. DISTRIBUTION District of Columbia and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose arm inspection was not documented. _______________ PRODUCT Red Blood Cells. Recall #B-685-8. CODE Unit #29KH18206. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by telephone on June 27, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had no hemoglobolin result documented. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========== _______________ PRODUCT Kendall Anesthesia/Breathing Circuits, used to ventilate or administer anesthesia to the patient during surgery: a) Standard Anesthesia Breathing Circuits b) Pediatric Anesthesia Breathing Circuits c) Jackson-Reese Circuits d) Customer Special Anesthesia Breathing Circuits. Recall #Z-272/275-8. CODE All lots as follows: 10101, 10107, 10113 10114, 10115, 10118, 10119, 10138, 10143 10145, 10146, 10149, 10153, 10165, 10172, 10173, 10174, 10175, 10180, 10181, 10185, 10189, 10191, 10192, 10193, 10197, 10199, 10200, 10204, 10205, 10207, 10208, 10209 10210, 10211, 10212, 10214, 10215, 10216 2430, 2432, 2434, 2435, 2442, 2447, 2448 2449, 2450, 2451, 2453, 2464, 2724, 2767 2854, 4123, 4183, 4936,4937, 4938, 4941 6381, 6622, 6677, 6679, 6787, 6791, 6794 6797, 6798, 6872, 6878, 6893, 8624, 8627 8632, 8664, 8667, 8683, 8686, 8687, 8688 8710, 8715, 8723, 8782, 8811, 9421, 9424 9425, 9445, 9521, 5997. MANUFACTURER Especialidades Medicas Kenmex, A Subsidiary of Tyco International, Ltd., Tijuana, Mexico. RECALLED BY Kendall Healthcare Products Company, Mansfield, Massachusetts, by letter dated July 21, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 35,837 cases (900,651 units) were distributed. REASON Circuit may disconnect during use, thus potentially interfering with the ability to ventilate a patient or administer anesthesia. _______________ PRODUCT Mobile Surgical Stretchers and Chairs: a) Mobile Surgical Stretcher, Model 578EYE-PC b) Mobile Surgical Stretcher, Model 578EYE-SS c) Ambulatory Surgical Chair, Model ASCEYE-00 d) Electric Motorized Ambulatory Surgical Chair, Model ESCEYE-00 e) Electric Motorized Ambulatory Surgical Chair, Model ESDEYE-00. Recall #Z-370/374-8. CODE Devices manufactured between May 20, 1997 and November 1, 1997. MANUFACTURER Hausted, Inc., Medina, Ohio. RECALLED BY Manufacturer, by letter on October 28, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Australia. QUANTITY 122 units were distributed. REASON The headrest adjustment assembly allows for the possibility of slippage if the set screw used to hold a lock collar in place is not properly tightened as it is in some instances. _______________ PRODUCT Lead Aprons, Skirts, Vests, and Thyroid Shields, shielding products used for radiation protection. Recall #Z-389/391-8. CODE All devices shipped after 1/29/97 through 6/16/97 to specific consignees based on identified suspect vinyl lead rolls received. MANUFACTURER Burkhart Roentgen International, Inc., St. Petersburg, Florida. RECALLED BY Manufacturer, by letter on June 16, 1997, followed by telephone. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 232 devices were distributed. REASON Radiation protection devices may contain small amounts of radioactive substances. _______________ PRODUCT CholestoChek Total Cholesterol Screening Test, promoted as an over-the-counter Home Screening Test Kit to determine Total Cholesterol. Recall #Z-392-8. CODE All unexpired codes. MANUFACTURER Technical Chemicals and Products, Inc. (also known as Health Mark Diagnostics L.L.C.) Pompano Beach, Florida. RECALLED BY Manufacturer, by letter on February 3, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 3,415 kits were distributed. REASON Lack of 510k for over-the-counter marketing. _______________ PRODUCT Marlow Balloon Cannula 5mm, Sterile, used for minimally invasive laproscopic surgery to provide access for operative and diagnostic instrumentation. Recall #Z-393-8. CODE Reorder #ML0500D, Lot #61-282-05-49. MANUFACTURER OEM - Franz Medical Development, LTD., Mentor, Ohio. RECALLED BY CooperSurgical, Inc., Shelton, Connecticut, by telephone on July 24, 1997 followed by fax. Firm-initiated recall complete. DISTRIBUTION California, Illinois, Maryland, Ohio, Texas, Virginia. QUANTITY 840 units were distributed. REASON Balloon Cannula may burst or leak at bonding site. _______________ PRODUCT Hewlett Packard Multifunction Electrode Pads, used with the HP Codemaster and Codemaster 100 Defibrillator/Monitors, intended as a multifunction external pad for ECG monitoring: a) M1749A-Adult U.S. Pads b) M1749B-Adult IEC Pads c) M1749B-Pediatric US Pads. Recall #Z-394/396-8. CODE Lot numbers: a) 040897, 050897, 020997, 030997 b) 200897; c) 260897. MANUFACTURER OEM Manufacturer: Cardiotronics Systems, Inc., a Division of Ballard Medical Products, Carlsbad, California. RECALLED BY Hewlett Packard Company, Medical Products Group, Andover, Massachusetts, by letter dated January 16, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 4004 boxes of lot M1749A(10sets/bx); 250 boxes of lot M1749B, and 100 boxes of lot M1749D(sets/box) were distributed. REASON The conductive gel may deteriorate to a liquid thus making the electrode pads unusable because they will not adhere to a patient and may not provide adequate electrical stimulation. _______________ PRODUCT Lead Aprons and Thyroid Collars, designed to be worn during surgical procedures: a) Standard Front, Catalog #101 b) Surgical Drop, Catalog #103 c) Two Wing Velcro, Catalog #105 d) 2" Buckle Front, Catalog #109 e) Lumbar Support Cinch Front, Catalog #120 f) Special Procedure, Catalog #201 g) Special Procedure Coat with Lumbar Cinch, Catalog 207 The above lead aprons models are followed by the letters L, M, S and P. Also, Model 105 may be preceded by the letter E. h) Half Aprons, Catalog #401 The half aprons catalog number is followed by the letters A, C or T. i) Thyroid Collar, Catalog #501 The thyroid collars catalog number is followed by the letters A or B. Recall #Z-397/405-8. CODE See above. MANUFACTURER Supplier of radioactive lead vinyl sheets: The Kennedy Company, Scottsboro, Alabama Supplier of radioactive lead powder: Taracorp Industries, Granite City, Illinois Source of radioactive lead: Midco Industries, St. Louis, Missouri RECALLED BY Davis Lead Aprons, Inc., Houston, Texas, by letter dated June 13, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Arizona, Georgia, Kentucky, Louisiana, North Carolina, Tennessee, Texas. QUANTITY Quantity Distributed: 179 units--15 model 101, 8 model 103, 13 model 105, 22 model E105, 5 model 109, 21 model 120, 1 model 201, 3 model 207, 9 model 401, and 66 model 501. REASON The radiation protection devices contain lead contaminated with small amounts of radioactive substances. _______________ PRODUCT Silicone "Squeegee" Capsule Polisher, Catalog and Part #125-23, used by ophthalmic surgeons for polishing the inside of the capsule during IOL/cataract surgery. Recall #Z-406-8. CODE Lot #70702. MANUFACTURER Eagle Laboratories, Rancho Cucamonga, California. RECALLED BY Manufacturer, by letter dated September 15, 1997. Firm-initiated recall ongoing. DISTRIBUTION California, Illinois, Louisiana, Massachussets, Texas, Virginia, Wisconsin. QUANTITY 480 units were distributed. REASON The sterility of the device may be compromised due to incomplete pouch package seals. _______________ PRODUCT Zimmer Versys Cemented Stem Inserter Clamp, Catalog #00-7896-051-00, used to hold the stem on the inserter during placement and impaction into the femoral canal. Recall #Z-407-8. CODE Lot numbers: 51899100, 51899200, 51899300. MANUFACTURER Zimmer, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by letter dated November 13, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 202 units were distributed. REASON The ball tip of the femoral inserter clamp broke during, possibly due to usage in an unintended manner. END OF ENFORCEMENT REPORT FOR MARCH 18, 1998. 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