April 2, 1997 97-14 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Eggnog Cheesecake, net weight 3 pounds 1 ounce. Recall #F-270-7. CODE None. MANUFACTURER Moonstruck Chocolatier, Portland, Oregon. RECALLED BY Manufacturer, by telephone beginning on November 27, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 100 cakes were distributed between October and November. REASON The products contain undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No.1 and FD&C Red No.3. _______________ PRODUCT Chewsey Fruits Candy, in 8 ounce packages. Recall #F-273-7. CODE None. MANUFACTURER Rayge Candy Company, Bricktown, New Jersey. RECALLED BY Manufacturer, by letter dated November 1, 1996, followed by visit by November 8, 1996. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 5 cases were distributed; firm estimates none remains on the market. REASON Product contains undeclared certified colors, FD&C Yellow No. 5 & 6. _______________ PRODUCT Pork & Beans in Tomato Sauce, in 16 ounce cans distributed under Phillips and Gibbs labels. Recall #F-276-7. CODE Product is marked with a two line code on The top line the involved are 36262 HPBS and 46262 HPSB and the second line has a military time between 15:00 and 23:00 SEPT 98. MANUFACTURER Hanover Foods Corporation, Hanover, Pennsylvania. RECALLED BY Manufacturer, by telephone on January 10, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia, North Carolina, Pennsylvania, Maryland. QUANTITY Firm estimates none remains on the market. REASON Some cans of product contain a small amount of undeclared corn. ________________ PRODUCT Nations Winners brand Spark of Life "Multi- Nutritional Drink with Whole Leaf Aloe Vera Vitamins, Minerals, Enzymes, and Herbs", in 32 fluid ounce plastic containers. Recall #F-278-7. CODE Batch 3844 on bottom of containers. MANUFACTURER Aloe Pro International, Farmers Branch, Texas. RECALLED BY Manufacturer, by letter dated November 7, 1996. Firm-initiated recall ongoing. DISTRIBUTION Georgia. QUANTITY 2,383 bottles were distributed. REASON Product contains undeclared FD&C Yellow No. 5 and bears an incorrect Vitamin C label declaration. _______________ PRODUCT Joe's Bakery Cookies, in 16 ounce hard plastic containers. Recall #F-279-7. CODE None. Product has a short shelf life. MANUFACTURER Carcione, Guiseppe & Costello, Maria, doing business as Joe's Bakery, Brooklyn, New York. RECALLED BY Manufacturer, by telephone on January 29, 1997, and February 5, 1997. Completed recall resulted from sample analysis and followup by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Firm estimates none remains on the market. -2-REASON Product contains the undeclared colors FD&C Yellow No. 5 and FD&C Red 40. _______________ PRODUCT Naturally Wholesome Banana Cake, in 2-1/2 ounce cellophane packages. Recall #F-280-7. CODE All codes including Jan 2 97. MANUFACTURER Neighborhood Bakery, Inc., also known as Payoo Industries, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by letter followed by visit . Completed field correction (relabelling) resulted from sample analysis and followup by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Firm estimates none remains on market. REASON Product contains undeclared FD&C Yellow No. 5. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Libby's Juicy Juice: (a) Tropical flavor; (b) Grape flavor; (c) Cherry flavor; (d) Punch flavor; (e) Variety Pack (Punch, Grape and Cherry flavors). Recall #F-246/250-7. CODE (a) Product code 28000-39110, date codes 5-Aug-97 and 6-Aug-97, 250 ml tetra pak, 27/case (b) Product code 28000-39210, date code 6-Aug-97, 250 ml tetra pak, 27/case (c) Product code 28000-39410, date codes 7-Aug-97 and 8-Aug-97, 250 ml tetra pak, 27/case product code 28000-39960, date codes 4-Aug-97 and 5-Aug-97, 125 ml tetra pak, 44/case (d) Product code 28000-39610, date codes 4-Aug-97, 5-Aug-97, and 8-Aug-97, 250 ml tetra pak, 27/case (e) Product code 28000-39920, date codes 6-Apr-97, 27-Apr-97, 28-Apr-97, 30-Apr-97, 1-May-97, 19-Jun-97, Jul-97 (all dates 07 through 31), and Aug-97 (all dates 01 through 31) MANUFACTURER Sweet Ripe Drinks Ltd., Ontario, Canada (finished product); Resero Company, Argentina (juice concentrate). RECALLED BY Nestle Beverage Company, San Francisco, California, by letter faxed on December 13, 1996. Firm-initiated recall ongoing. -3-DISTRIBUTION Maryland, Pennsylvania, Florida, New Jersey, New York, Connecticut, Virgin Islands, North Carolina, Virginia, Ohio, Maryland, Georgia, Maine, Alabama. QUANTITY 50,230 cases (27 per case) were distributed. REASON One of the juice concentrates used as an ingredient in these products was found to contain added sweetener. _______________ PRODUCT Stop & Shop Fruit Punch from Concentrate, in 8.5 fluid ounce containers. Recall #F-274-7. CODE EXP AUG 5/97 stamped at apex of container. MANUFACTURER Fisher Brothers Brands Ltd., Quebec, Canada. RECALLED BY The Stop & Shop Supermarket, North Quincy, Massachusetts, by E-mail on February 28, 1997, follow-up notification was sent on March 4, 1997. Firm-initiated recall ongoing. DISTRIBUTION Massachusetts, Connecticut, Rhode Island, New York, New Jersey. QUANTITY 110 cases (8 3-packs per case) were distributed. REASON Product is contaminated with mold. _______________ PRODUCT Hunter brand Smoked Oysters in cottonseed oil, in 3.75 ounce (105g) metal cans. Recall #F-277-7. CODE OYSO BY2 5413 and 0YSO BY2 5421. MANUFACTURER Shinjin Moolsan Company, Ltd., Kyungnam, Korea. RECALLED BY Consolidated Stores Corporation, Columbus, Ohio, by E-Mail message sent on January 31, 1997, and February 3 and 21, 1997. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 318 cases (24 cans per case) were distributed. REASON Oysters were found to be decomposed. _______________ PRODUCT Carbonated Soft Drinks: 1. Pepsi Cola (10 fl. ozs., 12 fl. ozs., 20 fl. ozs., 1 Liter, 2 Liter, 3 Liter) 2. Caffeine Free Pepsi (12 fl. ozs., 2 Liter) 3. Diet Pepsi (10 fl. ozs., 12 fl. ozs., 20 fl. ozs., 2 Liter, 3 Liter) 4. Diet Caffeine Free Pepsi (12 fl. ozs., 2 Liter) 5. Josta (20 fl. ozs.) 6. Mountain Dew (10 fl. ozs., 12 fl. ozs., 20 fl. ozs., 1 Liter, 2 Liter, 3 Liter) -4- 7. Diet Mountain Dew (12 fl. ozs., 20 fl. ozs., 2 Liter, 3 Liter) 8. Caffeine Free Mountain Dew (12 fl. ozs., 20 fl. ozs., 2 Liter) 9. Diet Caffeine Free Mountain Dew (2 Liter) 10. Orange Slice (12 fl. ozs.) 11. Dr. Pepper (12 fl. ozs., 20 fl. ozs., 2 Liter) 12. Diet Dr. Pepper (12 fl. ozs., 2 Liter) 13. 7-Up (12 fl. ozs., 20 fl. ozs., 2 Liter) 14. Diet 7-Up (12 fl. ozs., 20 fl. ozs., 2 Liter) 15. Cherry 7-Up (2 Liter) 16. Sunkist Orange (12 fl. ozs., 2 Liter) 17. Canada Dry Club Soda (10 fl. ozs.) 18. Canada Dry Ginger Ale (10 fl. ozs.) 19. Canada Dry Tonic (10 fl. ozs.) 20. All Sport Blue Ice (20 fl. ozs., 32 fl. ozs., 64 fl. ozs.) 21. All Sport Cherry Slam (20 fl. ozs., 32 fl. ozs., 64 fl. ozs.) 22. All Sport Fruit Punch (12 fl. ozs., 20 fl. ozs., 32 fl. ozs., 64 fl. ozs.) 23. All Sport Grape (12 fl. ozs., 20 fl. ozs., 32 fl. ozs., 64 fl. ozs.) 24-7 All Sport Lemon Lime (12 fl. ozs., 20 fl. ozs., 32 fl. ozs., 64 fl. ozs.) 25. All Sport Orange (12 fl. ozs., 20 fl. ozs., 32 fl. ozs., 64 fl. ozs.) 26. Pepsi Cola Premix 27. Diet Pepsi Premix 28. Mountain Dew Premix 29. Dr. Pepper Premix. Recall #F-281/309-7. CODE 1. 10 fl. ozs. xxxxTS021273 12 fl. ozs. xxxxTS020771 xxxxTS021271 20 fl. ozs. xxxxTS020673, xxxxTS021073 1 Liter xxxxTS021373 2 Liter xxxxTS020672 xxxxTS020772, xxxxTS021072 xxxxTS021272, xxxxTS021372 3 Liter xxxxTS021372 2. 12 fl. ozs. xxxxTS021071 2 Liter xxxxTS021072 3. 10 fl. ozs. xxxxTS021273 12 fl. ozs. xxxxTS021071, xxxxTS021471 20 fl. ozs. xxxxTS020673, xxxxTS021173 2 Liter xxxxTS021172 3 Liter xxxxTS021372 4. 12 fl. ozs. xxxxTS020671, xxxxTS021071 2 Liter xxxxTS021072 5. 20 fl. ozs. xxxxTS021173 -5- 6. 10 fl. ozs. xxxxTS021273 12 fl. ozs. xxxxTS020671, xxxxTS021171 xxxxTS021371 20 fl. ozs. xxxxTS020673, xxxxTS021073 xxxxTS021173 1 Liter xxxxTS021373 2 Liter xxxxTS021272, xxxxTS021372 3 Liter xxxxTS021372 7. 12 fl. ozs. xxxxTS021071, xxxxTS021471 20 fl. ozs. xxxxTS020673, xxxxTS021173 2 Liter xxxxTS020672, xxxxTS021172 3 Liter xxxxTS021372 8. 12 fl. ozs. xxxxTS021271 20 fl. ozs. xxxxTS021173 2 Liter xxxxTS021272 9. 2 Liter xxxxTS021172 10. 12 fl. ozs. xxxxTS020671, xxxxTS021171 11. 12 fl. ozs. xxxxTS021171 20 fl. ozs. xxxxTS021173 2 Liter xxxxTS020672, xxxxTS021172 12. 12 fl. ozs. xxxxTS021271 2 Liter xxxxTS020672 13. 12 fl. ozs. xxxxTS021171 20 fl. ozs. xxxxTS021173 2 Liter xxxxTS020672, xxxxTS021172 xxxxTS021272 14. 12 fl. ozs. xxxxTS021171 20 fl. ozs. xxxxTS021073 2 Liter xxxxTS020772, xxxxTS021172 15. 2 Liter xxxxTS020772 16. 12 fl. ozs. xxxxTS020671, xxxxTS021271 2 Liter xxxxTS021072 17. 10 fl. ozs. xxxxTS021273 18. 10 fl. ozs. xxxxTS021273 19. 10 fl. ozs. xxxxTS021273 20. 20 fl. ozs. xxxxTS020873, xxxxTS021473 32 fl. ozs. xxxxTS020873 64 fl. ozs. xxxxTS021473 21. 20 fl. ozs. xxxxTS020873, xxxxTS021473 32 fl. ozs. xxxxTS020873 64 fl. ozs. xxxxTS020873 22. 12 fl. ozs. xxxxTS020771, xxxxTS021471 20 fl. ozs. xxxxTS020873 32 fl. ozs. xxxxTS020873 64 fl. ozs. xxxxTS020873, xxxxTS021473 23. 12 fl. ozs. xxxxTS020771 20 fl. ozs. xxxxTS020873 32 fl. ozs. xxxxTS020873 64 fl. ozs. xxxxTS020873, xxxxTS021473 24. 12 fl. ozs. xxxxTS020771, xxxxTS021471 20 fl. ozs. xxxxTS020873, xxxxTS021473 32 fl. ozs. xxxxTS020873 64 fl. ozs. xxxxTS020873 -6- 25. 12 fl. ozs. xxxxTS021471 20 fl. ozs. xxxxTS020873 32 fl. ozs. xxxxTS020873 64 fl. ozs. xxxxTS021473 26. Nov 17, 97 27. May 26, 97 28. Aug 18, 97 29. Nov 10, 97. MANUFACTURER PepsiCo South, Knoxville, Tennessee. RECALLED BY Manufacturer, by visit to be completed by close of business on February 21, 1997. Firm- initiated recall ongoing. DISTRIBUTION Tennessee and Georgia. QUANTITY Approximately 137,000 cases (all sizes and package types) were distributed; firm estimated that the majority of these cases would have been consumed prior to the initiation of recall. REASON Products have an off-odor and off taste. _______________ PRODUCT America's Choice Thick and Chunky Hot Salsa, packed in 26 ounce glass jars. Recall #F-314-7. CODE "B7B19 41 stamped on jar caps, B7B19 stamped on shipping cases. MANUFACTURER Torbitt & Castleman Company, Buckner, Kentucky. RECALLED BY Manufacturer, by mail on March 14, 1997. Firm-initiated recall ongoing. DISTRIBUTION Georgia, Vermont, New Jersey. QUANTITY 55 cases (12 jars per case) were distributed; firm estimates none remains on the market. REASON Product was under processed, causing it to ferment and pop lids off of the product. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ UPDATE UDL Laboratories (Rockford, Illinois), Cefaclor Capsules, USP, 250 mg and 500 mg, Recall #D-130/131-7, which appeared in the March 26, 1997, Enforcement Report should read: Product is unit dose packaged in 10 strips of 10 capsules per shelf carton. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-291/294-7. -7-CODE Unit numbers: (a&b) 1117668, 1136572, 1214792; (c) 1117668, 1214792; (d) 1136572. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated May 24, 1996. Firm-initiated recall complete. DISTRIBUTION Kentucky, Ohio. QUANTITY (a) 3 units; (b) 3 units; (c) 2 units; (d) 1 unit was distributed. REASON Blood products were collected from a donor who initially tested HCV reactive was not deferred nor properly reentered. _______________ PRODUCT Red Blood Cells. Recall #B-487-7. CODE Unit numbers: 53Q55219, 53Q54223, 53Q53198. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 7, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland, Pennsylvania, District of Columbia. QUANTITY 3 units were distributed. REASON Blood products were collected from a donor who reported travel to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-478-7. CODE Unit numbers: M38039, M37526, M36994, M36262. MANUFACTURER Tri-Counties Blood Bank, Inc., Santa Barbara, California. RECALLED BY Manufacturer, by letter dated January 20, 1995. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 4 units were distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-492-7. CODE Unit #26146-0328. MANUFACTURER Blood Systems, Inc., Rogers, Arkansas. RECALLED BY United Blood Services, Fort Smith, Arkansas, by telephone on July 19, 1996. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of cancer. -8-_______________ PRODUCT Red Blood Cells. Recall #B-493-7. CODE Unit numbers: 12LF01581, 12LF04609, 12LF06740, 12LZ06324, 12LZ08584, 12LZ11633, 12LF12388, 12LF16806, 12LF18747, 12LF21411, 12LC19144, 12FZ11305, 12FZ13413, 12FZ20291, 12FZ22623, 12FZ24416, 12FZ15942, 12FZ18198. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 1, 3, 1996, or July 5, 1995. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 18 units were distributed. REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. _______________ PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Fresh Frozen Plasma. Recall #B-496/498-7. CODE Unit numbers: 12C55093, 12E61490, 12GE10063, 12E70173, 12GH46339, 12GC31099, 12GH52169, 12GE23620, 12GH60568. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 10, 1996 or May 21, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY (a) 1 unit; (b) 8 units; (c) 1 unit was distributed. REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc), were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-499/500-7. CODE Unit #12FL83579. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letters dated January 22 and 23, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit of each component was distributed. -9-REASON Blood products tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV), were collected from a donor who previously tested repeatedly reactive for anti-HCV. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-501/503-7. CODE Unit numbers: (a & b) 12LJ02816; (c) 12FV35378. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated January 22, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV), were collected from a donor who previously tested repeatedly reactive for anti-HCV. _______________ PRODUCT Red Blood Cells. Recall #B-505-7. CODE Unit #12LJ18563. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated June 17, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who emigrated from an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-506-7. CODE Unit #12GE20198. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated January 31, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly for anti-HBc on two separate occasions. -10-_______________ PRODUCT Red Blood Cells. Recall #B-508-7. CODE Unit #12GC27932. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 15, 1996. Firm-initiated recall complete. DISTRIBUTION South Carolina. 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 for anti-HBc on two separate occasions. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-509/511-7. CODE Unit numbers: (a) 12E77883, 12R54653; (b&c) 12E77883. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 1, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY (a) 2 units; (b&c) 1 unit was distributed. REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. _______________ PRODUCT (a) Whole Blood; (b) Red Blood Cells. Recall #B-512/513-7. CODE Unit numbers: (a) 12FF72206; (b) 12GC43841, 12FC45478. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letters dated April 18, 19, or 25, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY (a) 1 unit; (b) 2 units were distributed. REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc) were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets, Pheresis. Recall #B-514/515-7. -11-CODE Unit numbers: (a) 12LJ18519; (b) 12GP03643, 12GP03842. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 29, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY (a) 1 unit; (b) 2 units were distributed. REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-516/518-7. CODE Unit numbers: (a) 12LC05579, 12L98175, 12L12938; (b&c) 12LC05579. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated July 9 or 18, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY (a) 3 units; (b & c) 1 unit was distributed. REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-519/521-7. CODE Unit numbers: (a) 12FH60303, 12FP00085, 12FX19419; (b) 12FH60303; (c) 12FH60303, 12FX19419. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letters dated July 8, 10, or 12, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY (a) 3 units; (b) 1 unit; (c) 2 units were distributed. REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions. _______________ PRODUCT Platelets, Pheresis. Recall #B-522-7. CODE Unit #1314-1275-02. -12-MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Manufacturer, by telephone on July 15, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-524/525-7. CODE Unit numbers: 53Q55615, 53Q54322, 53Q53223. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 7, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland and District of Columbia. QUANTITY 3 units of each component were distributed. REASON Blood products were collected from a donor who reported travel to an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-526/527-7. CODE Unit #49S53709. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by letter dated December 27, 1996. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area considered endemic for malaria. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-494/495-7. CODE Unit #KE49457. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter on June 3, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose donor history screening was inadequately performed. -13-_______________ PRODUCT Red Blood Cells. Recall #B-504-7. CODE Unit #12FZ30252. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated May 8, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was stored at unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-523-7. CODE Unit #26146-4190. MANUFACTURER United Blood Services, Fort Smith, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arkansas, by letter dated October 16, 1996. Firm-initiated recall complete. DISTRIBUTION Arkasas. QUANTITY 1 unit was distributed. REASON Blood product may have remained at room temperature for an unacceptable length of time. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT 7200 Series Ventilators System with Pulsed Alarm Option and Pulsed Alarm Kits. Recall #Z-349-7. CODE Lot numbers 704 and 729. MANUFACTURER Nellcor Puritan Bennett, Carlsbad, California. RECALLED BY Manufacturer, by telephone and by fax dated August 22, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide, France, New Zealand, Canada. QUANTITY 70 units were distributed. REASON The optional pulsed alarm was not loud enough for the user facilities to hear. _______________ PRODUCT Airway Modules with Optional Spirometry Functions used with the AS/3 Anesthesia Monitor: (a) Model G-AOV, Measure C02, N20, 02 Anesthetic Agent with Side Stream Spirometry; (b) Model No. G-AiOV, Measure C02, N20, 02 Anesthetic Agent Side Stream Spirometry. Recall #Z-350/351-7. CODE Modules: G-AOV, G-AiOV MANUFACTURER Datex-Engstrom Division, Helsinki, Finland. -14-RECALLED BY Datex-Engstrom, Inc., Tewksbury, Massachusetts, by letter dated January 10, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY (a) 26 units; (b) 760 units were distributed. REASON A defective tantalum capacitor (C17) on the PVX Board (pressure and volume measurement) partly burned and short-circuited, resulting in the spread of fire to the tubing and some plastic parts inside the module. _______________ PRODUCT Fluoroscan I and III Promotional Videotape, with a 1992 copyright at the end of the tape. Recall #Z-353-7. CODE All tapes distributed prior to August 1996. MANUFACTURER FluoroScan Imaging Systems, Inc., Northbrook, Illinois. RECALLED BY Manufacturer, by undated letter sent on March 14, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Undetermined. QUANTITY Undetermined. REASON The device has indications that extend the use of the device beyond extremity imaging. _______________ PRODUCT ImmunoCard H. pylori, Catalog #710030, used for the detection of IgG antibodies to Helicobacter pylori in human serum and plasma. Recall #Z-354-7. CODE Lot #710030.024. MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by telephone on February 25, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Italy. QUANTITY 206 kits were distributed. REASON The enzyme conjugate reagent causes false positive results with patient specimens and the negative control. _______________ PRODUCT Hewlett Packard Ultrasound Transducers, transducer frequencies are available for a variety of imaging applications, including abdominal and cardiac, fetal imaging and neonatal head. Recall #Z-355/374-7. CODE Model Serial Description 21200C 3412AOO651 2.5 MHz transducer 3412AO6749 3412AO6961 -15- 21202A 3412AO5578 2.5 NHz / 2.0 MHz 3412AO5594 transducer 21205C 3412AO2644 3.5 MHz transducer 3412AO2667 21210B 3412AO2731 5.0 MHz medium focus transducer 21211B 3412AO2761 5.0 MHz short focus 3412AO2812 transducer 3412AO2840 3412AO2927 21215A 3425AOI301 2.5 MHz / 2.0 MHz transducer 21253A 3412AOO531 3.5 MHz CLA transducer 21253B 3519AOO278 3.5 MHz CLA transducer 3519AOO2807 3519AOO285 3519AOO301 3519AOO304 3519AOO459 3519AOO478 354OA00123 354OA00131 3542AOO373 21255B 3412AOO497 4.5 MHz / 3.5 MHz trapezoidal transducer 21958B 3507AOO962 7.5 MHz / 5.5 MHz 3507AOII69 trapezoidal linear array 3507AOI365 transducer 3507AOI366 3507AO1402 3507AO1419 3542AO1786 3542AO1799 3542AO1911 21275A 3434AO1447 7.5 MHz / 5.5 MHz transducer 21302A 3426AOO215 2.5 MHz/ 2.0 MHz transducer 21358B 3507AOO275 7.5 MHz / 5.5 MHz 3507AOO292 trapezoidal linear array transducer 21363A 3412AOO577 5.0 MHz Biplane TEE transducer 21370A 3441AOO1O4 7.5 MHz / 5.0 MHz 3441AOO125 Endovaginal transducer 3441AOO191 3441AOO195 3441AOO201 3441AOO204 3441AOO217 3441AOO265 3441AOO283 -16- 3441AOO285 3441AOO413 21372A 3551AOO138 7.5 MHz 5.0 MHz Small 3618AOO206 Parts CLA transducer 3618AOO210 21373A 3513AOO225 5.0 MHz Curvilinear 3513AOO250 transducer 3513AOO290 3513AOO356 21402A 2917AO3855 2.5 MHz CW/I Sonos 100 3312AO2631 transducer 3312AO3058 3312AO9754 3312AO9762 3312AO9763 3312AO9764 3312AO9766 3312AO9768 3312AO9769 3312AO9771 3312AO9824 3312A10478 3312A11946 3312A11965 3312A12480 21415A 3312AO8809 7.5 MHz Sonos 100 3312A11035 imaging transducer 3312A11440 21445A 3104AO4865 10MHZ imaging transducer MANUFACTURER Hewlett Packard Company, Andover, Massachusetts. RECALLED BY Manufacturer, by letter dated January 27, 1997. Firm-initiated field correction ongoing. DISTRIBUTION California, Colorado, Florida, Georgia, Kentucky, Minnesota, Montana, New York, Ohio, international. QUANTITY 86 transducers were distributed. REASON There may be slight image degradation. _______________ PRODUCT Argyle Turkel Safety Toracentesis System and Procedure Tray: (a) Argyle Turkel Safety Thoracentesis System, Catalog No. 8888-566034, (b) Argyle Turkel Safety Thoracentesis Procedure Tray, Catalog No. 8888-566059. Recall #Z-375-376-7. CODE Lot Numbers: (a) WO80333A, WO80334A, WO80335A, WO81348A, WO81349A, WO83279A, WO85088A, WO85089A, WO86537A, WO86538A, -17- WO86539A, WO86540A, WO87939A, WO87938A, WO87937A, WO99165A, WO99167A, WO102803A, WO99166A, WO102804A, WO99168A, WO93348A, WO105541A, WO105540A, WO93349A, WO106947A, WO106949A, WO102802A, WO105539A, WO106948A; (b) 899874, 800151, 800555, 800812, 800811, 801090, 801353, 801658, 802195. MANUFACTURER Boston Scientific Company, Miami, Florida (single device). RECALLED BY Sherwood Davis & Geck, St. Louis, Missouri, by letter dated February 14, 1997. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY (a) 13,789 systems; (b) 20,447 trays were distributed between 1/18/96-2/4/97. REASON The one-way safety ball valve in the devices may malfunction allowing air leakage into the pleural space. _______________ PRODUCT Solar 7000/8000 Patient Monitors, used with Solar ECG/12SL Modules, to display physiological data from modules which monitor the patient for ECG, blood pressure, etc. Recall #Z-377-7. CODE All versions of software prior to Version 3. MANUFACTURER Marquette Electronics, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by letter sent on February 14, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Maryland, Minnesota, Texas, Italy, India. QUANTITY 48 Solar ECG/12SL Modules were distributed. Only the Solar 7000/8000 Patient Monitors used with Solar ECG/12SL Modules are affected and the software in these monitors is to be replaced. REASON The device produces output which is incorrect. (The data from one patient lead replaces the data from another patient lead.) _______________ PRODUCT Abbott TestPack Strep A, in-vitro diagnostic enzyme immunoassay for the rapid detection and confirmation of group A Streptococci from throat specimens: List #1301-22, 40 Tests, List #1301-82, 80 Tests. Recall #Z-378-7. CODE Lot numbers: 21937M200 (40 tests); 22515M300 (80 tests). MANUFACTURER Abbott Laboratories, Abbott Park, Illinois. RECALLED BY Manufacturer, by telephone on January 16, 17, 1997, followed by letter dated January 1997. Firm-initiated recall complete. -18-DISTRIBUTION Nationwide, Italy, Germany. QUANTITY 231 40-test kits and 123 80-test kits were distributed. REASON Devices can cause false positive results with patient specimens and the negative controls. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Paragon Screw-Vent Implant (SVA-16), a dental screw-type implant, packaged in a clear vial. Recall #Z-352-7. CODE Lot #074-10/99. MANUFACTURER Core BioEngineering Calabasas, California and Core-Vent Corporation, Las Vegas, Nevada. RECALLED BY Core-Vent Corporation, Las Vegas, Nevada, by telephone on January 31, 1997, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Wisconsin, Connecticut, Pennsylvania, New York, Utah, Massachusetts, Colorado, Ohio, California, Indiana, Maryland, Florida. QUANTITY 401 units were distributed. REASON Some Screw-Vent dental implants were labeled with incorrect dimensions and part numbers that did not reflect the actual measured values of the product. _______________ PRODUCT Clintec Model 2200 Enteral Feeding Pump, used in the administration of all enteral feeding formulas. Recall #Z-348-7. CODE Serial numbers: 16304 through 16603. MANUFACTURER Elan Pharma Inc., Smithfield, Rhode Island. RECALLED BY Manufacturer, by letters on March 23, 1995, May 3 and 10, 1995. Firm-initiated field correction complete. DISTRIBUTION Nationwide. QUANTITY 299 pumps were distributed. REASON The pumps may have been manufactured with the incorrect instruction labels. -19- END OF ENFORCEMENT REPORT FOR APRIL 2, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for