January 2, 1997 97-01 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Refrigerated Shucked Mussel Meat Products, in 10 ounce cups, half gallons, or gallons: (a) Lightly Poached Mussel Meats (b) Marinated Mussel Meats (c) Marinated Mussel Meats with Jalapeno Peppers; (d) Mussel Meats in Tomato Basil Sauce. Recall #F-152/155-7. CODE Products produced between September 1 and October 31, 1996 with sell by dates ranging from September 14, 1996 to November 14, 1996 (10 ounce cups); and with sell by dates ranging from September 21, 1996 to November 21, 1996 (half gallons and gallons). MANUFACTURER Blue Gold Holdings, Inc., New Bedford, Massachusetts. RECALLED BY Manufacturer, by press release November 6, 1996. Firm-initiated recall complete. DISTRIBUTION Massachusetts, New York, Pennsylvania, Maryland, Virginia, Ohio, Florida. QUANTITY Firm estimates none remains on the market. REASON Products may be contaminated with Listeria monocytogenes. _______________ PRODUCT Pillsbury Date Quick Bread Mix, in 1 pound 0.6 ounce boxes. Recall #F-156-7. CODE Codes beginning with C6M20. MANUFACTURER The Pillsbury Company, Murfreesboro, Tennessee. RECALLED BY The Pillsbury Company, Minneapolis, Minnesota, by electronic mail on November 26, 1996, and by press release on November 27, 1996. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 3,271 cases (12 boxes per case) were distributed. REASON Product contains undeclared walnuts and almonds. _______________ PRODUCT Reese's Peanut Butter Chip variety of Mighty Muffins, sold day old, in clear plastic or styrofoam cartons. Each carton may contain several varieties of muffins. Recall #F-157-7. CODE All packages of Mighty Muffins which contain Reese's Peanut Butter Chip Muffin variety, but do not declare peanuts on the label. MANUFACTURER Various Tops Markets (grocery stores), in New York and Pennsylvania. RECALLED BY Tops Markets, Williamsville, New York, by E-mail dated December 2, 1996, and by bulletin sent on December 3, 1996. Firm-initiated recall complete. DISTRIBUTION New York and Pennsylvania. QUANTITY Undetermined. REASON Undeclared peanuts on the label of some packages of Mighty Muffins containing Reese's Peanut Butter Chip Muffins. _______________ PRODUCT Fat Free Chocolate Brownies, individually wrapped and packaged under the following labels and configurations: (a) Plantation Brownies, Baked by Plantation Baking Company, Inc., Lake Bluff, Illinois: i) individually wrapped brownies, Net Wt. 1.4 oz., sold as singles in vending machines and from 15 count display trays ii) five count multi-pack brownies, no labeling on individual units, Net Wt. 7 oz., (b) Famous Amos Brownies, President Baking Company, Inc., Atlanta, Georgia: i) individually wrapped brownies, Net Wt. 1.4 oz., sold as singles from 5 count and 48 count display trays -2- ii) five count multi-pack brownies, no labeling on individual units, Net Wt. 7 oz. Recall #F-158-7. CODE Plantation brownies have product codes XA621 and XA615; Famous Amos brownies have production code 03097U3. MANUFACTURER Plantation Baking Company, Inc., Lake Bluff, Illinois. RECALLED BY Manufacturer, by press release, interoffice memo, and telephone beginning on November 27, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 877 cases were distributed. REASON Product contains undeclared walnuts. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Poland Spring Natural Spring Water in .5 liter (16.9 ounce) plastic bottles. Recall #F-044-7. CODE A. "101696 xxxx EXP101698 L8" stamped on bottle neck. "101696 xxxx L8" on cases. "xxxx" indicates 24 hour "military " time. Firm is recalling military time code 0115 to 0200(indicating filling between 1:15AM and 2 AM ) on 10/16/96. NOTE: "xxxx" on cases indicates time cased. L8= filling line 8 (only 0.5 liter is filled on line 8). Additional codes being recalled: B. "101696" with fill time code 2330-0000 [indicating filling 11:30PM to 12:00AM on 10/16/96]. C. "101796 xxxx EXP101798 L8" stamped on bottle neck. "xxxx" indicates fill time codes 2330-0000 [filled 11:30PM to 12:00AM on 10/17/96]. D. "101896 xxxx EXP101898 L8" stamped on bottle neck. "xxxx" indicates fill time codes 0000-0030 [filled 12:00AM to 12:30AM] **. MANUFACTURER Great Spring Waters of America, Inc., doing business as Poland Spring Bottling Company, Poland Spring, Maine. RECALLED BY Manufacturer, by letters of October 29 and 31, 1996, and November 8, 1996, followed by visit. Firm-initiated recall ongoing. DISTRIBUTION Massachusetts, Ohio, New York, New Jersey, Pennsylvania, Connecticut, Vermont, Maryland, Michigan, Virginia, North Carolina, Illinois, Georgia, Wisconsin. QUANTITY Undetermined. REASON Product is contaminated with chlorine. -3-_______________ PRODUCT Green Leaf Lettuce, 12 heads per carton under the Western Express or the U.S. Fresh brand. Recall #F-129-7. CODE None. MANUFACTURER Kophamer & Kophamer, Bakersfield, California (grower and harvester). RECALLED BY Norton Enterprises, Monterey, California (broker), by telephone on or about April 19, 1995. Firm-initiated recall complete. DISTRIBUTION California and New Jersey. QUANTITY 1,612 cartons (12 heads per carton) REASON Product contains endosulfan which exceeds the established tolerance of 2.0 ppm for this pesticide in lettuce. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Java Johnny, Natural Spring Water with caffeine, in 20 fluid ounce plastic bottles containing 24 bottles per case. Recall #F-159-7. CODE No codes are listed on the bottles. Lot #2906, produced on 10/16/96. MANUFACTURER Northstar Beverage, Inc., Detroit, Michigan. RECALLED BY Thunderhead Beverages, Inc., Cincinnati, Ohio (distributor), by telephone on November 1, 1996. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 540 cases (24 bottles per case) were distributed. REASON Cracked pull-top tabs caused some bottles to become contaminated and appear cloudy. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-118/120-7. CODE Unit #8528717. MANUFACTURER The Blood Center for Southeast Louisiana, New Orleans, Louisiana. RECALLED BY Manufacturer, by letter dated August 23, 1996. Firm-initiated recall complete. DISTRIBUTION Louisiana and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for antibody to the human immunodeficiency virus type 1 (anti- HIV-1), were collected from a donor who previously tested repeatedly reactive for anti-HIV-1 and was incorrectly reentered. -4-_______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-129/130-7. CODE Unit #17035-4781. MANUFACTURER United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 9, 1996. Firm-initiated recall complete. DISTRIBUTION Texas and North Carolina. 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) Cryoprecipitated AHF; (c) Recovered Plasma. Recall #B-166/168-7. CODE Unit numbers: 53FL52515 and 53FL51316; (b) 53FL52515; (c) 53FL52515. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated May 29, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland, North Carolina, California, District of Columbia, Switzerland. QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot positive. _______________ PRODUCT Platelets. Recall #B-169-7. CODE Unit #1K1488. MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington. RECALLED BY Manufacturer, by letter dated December 20, 1995. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose medical history screening was inadequately performed. _______________ PRODUCT (a) Red Blood Cells; (b) Single Donor Plasma. Recall #B-177/178-7. CODE Unit #KP02716. MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, California. -5-RECALLED BY Manufacturer, by letter dated October 18, 1993. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit of each component was distributed. REASON Blood products were labeled with an extended expiration date. _______________ PRODUCT Recovered Plasma. Recall #B-179-7. CODE Unit #N27938. MANUFACTURER North Colorado Medical Center, Greeley, Colorado. RECALLED BY Manufacturer, by letter dated August 19, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of intravenous drug use. _______________ PRODUCT Platelet, Pheresis. Recall #B-180-7. CODE Unit #C59325. MANUFACTURER Regional Health Resource Center, Community Blood Services of Illinois, Urbana, Illinois. RECALLED BY Manufacturer, by telephone on April 1, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT Source Plasma. Recall #B-183-7. CODE Unit numbers: VYC636, VYC933, VYD297, VYE642, VYE838, VVT148, VVU598. MANUFACTURER Bayer Corporation Plasma Center, Coon Rapids, Minnesota. RECALLED BY Manufacturer, by telephone and fax on January 19, 1995. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 7 units were distributed. REASON Blood products were collected from a donor who reported a history of an accidental needlestick. _______________ PRODUCT Source Plasma. Recall #B-184-7. CODE Unit numbers: 45360268, 45351432, 45363917, 45365188, 45367595, 45368813, 45373787, 45375019, 45372643, 45376122, 45378638, 45379772, 45392375, 45393365, 45395697, -6- 45396588, 45399114, 47380936, 47382411, 47384361, 47386020, 47387737, 47440210, 47442306, 47443785, 47446496. MANUFACTURER Simi Biological Resources, Inc., Fort Smith, Arkansas. RECALLED BY Manufacturer, by telephone on April 17, 1995, and by letter dated September 20, 1994. Firm- initiated recall complete. DISTRIBUTION California. QUANTITY 26 units were distributed. REASON Blood products were collected from a donor with a previous history of hepatitis. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-185/187-7. CODE Unit #53J17086. MANUFACTURER American Red Cross, Baltimore, Maryland. RECALLED BY Manufacturer, by letters dated September 19 and 25, 1996. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, Virginia, California. QUANTITY 1 unit of each component. REASON Blood products were collected in a manner that a contaminated unit was distributed. _______________ PRODUCT Source Plasma. Recall #B-188-7. CODE Unit numbers: 38551796, 38555893, 38556937, 38559440, 41992715, 41512517, 41513316, 41143889, 41157879, 45369643, 45375651, 45378768, 47389953. MANUFACTURER Simi Biological Resources, Inc., Fort Smith, Arkansas. RECALLED BY Manufacturer, by letter dated September 20, 1994, and by telephone on April 17, 1995. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 13 units were distributed. REASON Blood products were collected from a donor previously deferred for high risk behavior. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Recovered Plasma.Recall #B-131-7. CODE Unit #17035-4781. MANUFACTURER United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 9, 1996. Firm-initiated recall complete. DISTRIBUTION Texas and North Carolina. QUANTITY 1 unit of each component. -7-REASON Blood product was collected from a donor with a history of cancer. _______________ PRODUCT Recovered Plasma. Recall #B-170-7. CODE Unit #1K1488. MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington. RECALLED BY Manufacturer, by letter dated December 27, 1995. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor whose medical history screening was inadequately performed. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-181/182-7. CODE Unit numbers: (a) 09GN00093; (b) 09GN00094 09GN00102 09GN00113 09GN00123 09GN00095 09GN00104 09GN00114 09GN00124 09GN00096 09GN00106 09GN00115 09GN00125 09GN00097 09GN00107 09GN00116 09GN00126 09GN00098 09GN00108 09GN00117 09GN00128 09GN00099 09GN00110 09GN00118 09GN00129 09GN00100 09GN00111 09GN00119 09GN00130 09GN00101 09GN00112 09GN00120. MANUFACTURER American Red Cross Blood Services, Omaha, Nebraska. RECALLED BY Manufacturer, by telephone on July 13 and 14, 1995. Firm-initiated recall complete. DISTRIBUTION (a) Nebraska; (b) California. QUANTITY (a) 1 unit; (b) 31 units were distributed. REASON Blood products were prepared from whole blood which may have reached unacceptable room temperatures during shipment. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Operator's Manual and Front Panel Decal for the Medtronic M-300 Talc Sterilizer, dry heat sterilizer used to sterilize talc which is used by hospitals for thoracic surgeries. Recall #Z-089-7. CODE All manuals and units in distribution. MANUFACTURER Dentronix, Inc., Ivyland, Pennsylvania (spec. developer). -8-RECALLED BY Dentronix, Inc., Ivyland, Pennsylvania, by letter dated October 15, 1996. Firm-initiated recall ongoing. DISTRIBUTION Pennsylvania, Florida, Ohio, Hawaii, California, Tennessee, Kentucky, Washington state, Maryland, Michigan, Texas. QUANTITY 14 units were distributed. REASON The operators manual and the front panel of the device makes reference to instrument sterilization when the maximum temperature of the sterilizer is not sufficient to sterilize instruments. _______________ PRODUCT Acetabular Reamer Shell, 54mm, Catalog No. 1207-354. Recall #Z-183-7. CODE Lot Number 00041821. MANUFACTURER Linvatec Corporation, Division of Zimmer/Bristol-Squibb Company, Largo, Florida. RECALLED BY Manufacturer, by letter dated October 18, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia, Texas, Pennsylvania, Wisconsin, Minnesota, North Carolina, Tennessee, Washington state, California, Maryland, Arkansas, New York. QUANTITY 19 devices were distributed. REASON The reamer shell is etched to identify it as a 54mm shell when in fact it may be a 55mm shell. _______________ PRODUCT Posicam Auricle and Posicam HZL PET Laser System, used for patient positioning. Recall #Z-184/185-7. CODE Various serial numbers. MANUFACTURER Positron Corporation, Houston, Texas. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on November 18, 1996 ongoing. DISTRIBUTION Nationwide and international. QUANTITY 11 Auricle units and 5 HZL units were distributed. REASON Devices failed to comply with standards for reporting and labeling of laser products. _______________ PRODUCT Aurora Diode Laser, used in dental surgery. Recall #Z-186-7. CODE Various serial numbers. MANUFACTURER Premier Laser Systems, Inc., Irvine, California. -9-RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on December 12, 1996. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 52 units were distributed. REASON Noncompliance with performance standards for laser products in that the operator's manual lacked calibration procedures. _______________ PRODUCT HydroFlex Irrigation System Controller, Product #0025000, Firmware reversions 2.2 and 1.5, a reusable electromechanical controller intended to be used with either of two Davol HydroFlex Irrigation Tubing Sets. Recall #Z-188-7. CODE All serial numbers, used with HydroFlex AD Arthroscopic Distention/Irrigation Tubing Set and HydroFlex LI Laparoscopic Irrigation Tubing Set. MANUFACTURER DEKA Research & Development Corporation, Manchester, New Hampshire (contract manufacturer). RECALLED BY Davol, Inc., Subsidiary of C.R. Bard, Inc., Cranston, Rhode Island, by visit on or about October 28, 1996, to upgrade firmware to version 2.3. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 384 units were distributed. REASON When the controller is set to within 10% of the upper pressure limit, the controller motor can run at a level which produces a higher static pressure than specified and shown in the display window. _______________ PRODUCT MicroSeal Reusable Phacoemulsification Needles, used during ophthalmic surgery: (a) Catalog #DP8030, 30 Degree MicroSeal Needle; (b) Catalog #DP8045, 45 Degree MicroSeal Needle. Recall #Z-189/190-7. CODE (a) Package date code 96085; (b) Package date code 96086. MANUFACTURER Storz Instrument Company, St. Louis, Missouri. RECALLED BY Manufacturer, by letter dated October 28, 1996, followed by fax on December 9, 1996. Firm-initiated recall ongoing. DISTRIBUTION International. QUANTITY (a) 339 boxes (6 units per box); (b) 210 boxes (6 units per box) were distributed. -10-REASON The needles were packaged with the incorrect instructions for use. "Microflow Needle DP82XX Series Instructions for Use" were packaged with the products and lacks a warning statement instructing the user not to use the needle if the brown thermoprotective sleeve is missing or detached from the needle. _______________ PRODUCT Powered and manual wheelchairs: (a) Applause Manual Wheelchair, Product No. E20300-5XX; (b) Ovation Powered Wheelchair, Product No. DE20300-501; (c) Enabler Manual Wheelchair, Product No. E20000-5XX; (d) Electro-Lite Powered Wheelchair, Product Nos. DE90003A & DE90003A/L. Recall #Z-191/194-7. CODE All serial numbers lower than 303974 shipped prior to April 22, 1992. MANUFACTURER Damaco, Inc., Moorpark, California. RECALLED BY Manufacturer, by letters sent between July 2 and 5, 1996, and October 23, 1996. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 2,665 units were distributed; firm estimated that 2,177 units remained in commerce at time of recall initiation. REASON The rear wheel axle bolt may break when bending stress exceeds the carrying capacity. _______________ PRODUCT Collimator for Multispect 2 Gamma Camera Systems; designed for SPECT acquisitions/imaging studies utilizing Technetium and Thallium radionuclides. Recall #Z-195-7. CODE All units shipped prior to 2/18/96. MANUFACTURER Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, Illinois. RECALLED BY Manufacturer, by issuing a Mandatory Next Service Call Field Modification Instruction (FMI-00174) on December 11, 1996. Firm- initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 215 units were distributed. REASON The collimator latches intermittently fail to latch or unlatch due to high contact resistance of relays on the CLMD board inside the gantry. -11-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Seprafilm Bioresorbable Membrane, Part #4301- 03, indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct to reduce incidence of post-operative adhesions. Recall #Z-025-7. CODE Lot #N5043B. MANUFACTURER Genzyme Corporation, Framingham, Massachusetts. RECALLED BY Genzyme Corporation, Cambridge, Massachusetts, by letter on August 21, 1996. Firm-initiated recall complete. DISTRIBUTION Georgia, Florida, Pennsylvania. QUANTITY 4 boxes (10 units per box) were distributed. REASON Product was distributed without approved labeling for marketing in the United States. _______________ PRODUCT Extrude Putty Polyvinylsiloxant Dental Impression Material, sold under the following three configurations and part numbers: Extrude Putty Refill, Part No.# 18919: Putty packed in cardboard, package Contains:1-Jar Putty Base 280 ml 1-Jar Putty Catalyst 28 ml **"; Extrude Deluxe Introductory Kit, Part No.# 20229: Each kit contains one set of Extrude Putty Refill Part No. 18919. The introductory kit comes in a cardboard box labeled in part: "Extrude KERR Deluxe-Intro Kit **"; Case Extrude Putty Package, Part No.# 25079: This box contains 12 sets of Extrude Putty Refill Part No. 18919. Recall #Z-187-7. CODE All lot numbers with an expiration date of 9/96 through 7/97. This recall covers any Extrude Putty made within the past twelve months. The lot number and expiration date can be found printed on the bar code label affixed to the outer package. MANUFACTURER KERR Corporation, Romulus, Michigan. RECALLED BY Sybron Dental Specialties, Orange, California (responsible firm), by letter dated July 1, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 16,950 sets were distributed; firm estimated that 1,200 sets remained on market at time of recall initiation. REASON The device fails to set within the specified time frame. -12-_______________ PRODUCT Vitros DT NH3 Slides, for use with Vitros DT Chemistry Systems to quantitatively measure ammonia on the Ektachem (Vitros) DT60/DT60II analyzer. NOTE: The NH3 slides are also used in conjunction with Ektachem DT slides for CREATININE where NH3 slides serve only as a blank. Recall #Z-197-7. CODE Catalog #153 2589; Lot numbers: 1051-0123-2067; 1051-0123-3756; 1051-0123-5162; 1051-0123-5163; 1051-0124-2065; 1051-0124-3055; 1051-0124-3855; 1051-0167-1911; 1051-0167-3672; 1051-0167-6801; 1051-0167-6802; 1051-0168-1723. MANUFACTURER Johnson & Johnson Clinical Diagnostics, Rochester, New York. RECALLED BY Manufacturer, by letter dated October 15, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 37,092 boxes were distributed; firm estimated that 4,000 boxes remained on market at time of recall initiation. REASON The DT NH3 results were biased up to 40% higher than the reference method. -13- END OF ENFORCEMENT REPORT FOR JANUARY 2, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for