November 1, 2000 00-44RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Morey's Smoked Canadian Lake Trout, in plastic trays wrapped in cellophane, with net weights with a target of 1/2 to 3/4 pounds, and in bulk cases holding 5 pounds. Recall #F-022-1. CODE Lot #3616, Processed 225, "Not to be Sold or Consumed After Date" of 9/16/00. MANUFACTURER Morey's Fish Company, Motley, Minnesota. RECALLED BY Manufacturer, by telephone, letter and press release on August 29, 2000. Ongoing recall resulted from sample analysis and follow-up by the Michigan Department of Agriculture. DISTRIBUTION Illinois, Indiana, Kentucky, Michigan, Ohio, Wisconsin. QUANTITY 261.8 pounds were distributed. REASON The Michigan Department of Agriculture found the product contaminated with Salmonella.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT 12-Packs labeled as "Caffeine Free Coca Cola Classic" and individual cans labeled as "Caffeine Free Diet Coke". Recall #F-012-1. CODE Optimum Taste Date Code JUN1101RMA. MANUFACTURER Mid Atlantic Coca Cola Bottling, Sandston, Virginia. RECALLED BY Manufacturer, by letter October 2, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia and North Carolina. QUANTITY 10,325 cases were distributed. REASON Cans with Optimum Taste Date Code JUN1101RMA are labeled as Caffeine Free Diet Coke but actually contain Caffeine Free Coca Cola Classic. ________ PRODUCT Lemon Pepper Smoked Wild Salmon. Recall #F-014-1. CODE All product distributed prior to 9/6/00. MANUFACTURER C&H Classic Smoked Fish, Cathlamet, Washington. RECALLED BY Manufacturer, by visit between September 7 and 12, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY Firm estimates none remains on the market. REASON Product contained undeclared FD&C Yellow No. 5 Lake and FD&C Red No. 40. ________ PRODUCT Gombo Ancko Cream Bun, a cream filled bread product. Recall #F-019-1. CODE All product on the market at time of recall initiation. MANUFACTURER Poong Nyun Bakery, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on September 13, 2000, followed by visit September 26-27, 2000. Firm-initiated field correction (relabeling) complete. DISTRIBUTION New York and Pennsylvania. QUANTITY 200 packs were distributed. REASON Product contained undeclared FD&C Yellow No. 5. ________ PRODUCT Los Compadres brand Chicharrines (wheat pellets), in 8-ounce flexible plastic packages. Recall #F-020-1. CODE None. All product on the market at time of recall initiation. MANUFACTURER Los Compadres, Inc., Yonkers, New York. RECALLED BY Manufacturer, by visit May 24, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 200 8-ounce packages were distributed. REASON Product contained undeclared FD&C Yellow No. 6. ________ PRODUCT Smoked Salmon Tortellini in 8-ounce plastic containers. Recall #F-021-1. CODE Best Used By or Best Before sticker with any of the following dates: 10/04/00, 10/05/00, 10/07/00, 10/08/00, 10/11/00. MANUFACTURER Carso's Pasta Company, Inc., Lynnwood, Washington. RECALLED BY Manufacturer, by visit on October 2, 2000. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Washington state. QUANTITY 66 packages were distributed. REASON Product contained undeclared FD&C Yellow No. 6 and FD&C Red No. 40. ________ PRODUCT Tortillas, Shells, Tostadas, and Chips. Recall #F-023/026-1. Specific products under recall are: Retail Products a) Tortillas: 73731-00328 Mission 16 oz Yellow Corn Tortillas 73731-10101 Mission 82.5 oz Yellow Corn Tortillas 73731-10107 Mission 33 oz Yellow Corn Tortillas 73731-00316 Mission 14 oz Yellow Corn Tortillas 70343-00310 Diane's 7.5 Yellow Corn Tortillas 35833-07419 Best Buy 24 oz 30 ct Yellow Corn Tortilla (#3324) 35833-07422 Best Buy 36 oz 60 ct Rectangle Corn (#3326) 35833-07430 Best Buy 50 oz 100 ct Yellow Corn (#3329) 35833-07633 Best Buy 28 oz 60 ct Yellow Corn (#3356) 73731-00808 Alberto's Choice 24 ct/16 oz Yellow Corn Tortillas 92825-66528 Super One 24 ct/16 oz Yellow Corn Tortillas 92825-66548 Brookshires 24 ct/16 oz Yellow Corn Tortillas 55566-20119 Todos Santos 24 ct/16 oz Yellow Corn Tortillas 46145-00400 Minyard 16 oz Yellow Corn Tortillas 46145-00534 Minyard 86 oz Yellow Corn Tortillas 46145-00425 Sack'n Save 16 oz Yellow Corn Tortillas 46145-00429 Sack'n Save 86 oz Yellow Corn Tortillas 46145-00530 Carnival 16 oz Yellow Corn Tortillas 46145-00528 Carnival 86 oz Yellow Corn Tortillas 77948-01102 Calidad 18 oz Yellow Corn Tortillas 77948-01103 Calidad 30 oz Yellow Corn Tortillas 77948-01119 Calidad 88 oz Yellow Corn Tortillas 76477-00001 El Ranchito 13 oz Yellow Corn Tortilla 76447-03316 El Ranchito 43.5 oz Lite Crispy Y/Corn 76477-10003 El Ranchito 60 oz Yellow Corn Tortilla 76447-33703 El Ranchito 29 oz Lite Crispy Y/Corn 11110-89131 Kroger 6 oz Yellow Corn Tortillas 48564-22059 Guerrero 46 oz Yellow Corn Tortilla 48564-22783 Guerrero 33 oz Yellow Corn Tortilla 70038-36250 Best Choice Corn Tortillas code 36250 73731-00796 Alberto's Choice 16 oz Yellow Corn Tortilla 20922-20030 Super S Foods 22 oz Yellow Corn Tortilla b) Shells: 73731-00512 Mission Tostada Shells 73731-00284 Mission Taco Dinner Kit 73731-00511 Mission Taco Shells 73731-00634 Mission Jumbo Taco Shells 70343-00101 Diane's Taco Shells 70343-00117 Diane's Jumbo Taco Shells 70343-00119 Diane's 24 ct Taco Shell 48564-00114 Guerrero Taco Shells 90179-10011 El Maizal Taco Shells 41175-37734 Buena Comida Taco Shells 41163-44240 Albertson's 12 ct Taco Shell 42187-40848 Best Yet 12 ct Taco Shell 73731-00757 Butter Krust 12 ct Taco Shell 41498-15411 Casa Mamita 12 ct Taco Shell 058700-306058 Campbells 12 ct Taco Shell 37600-14379 Chi Chi's Hormel 12/10 Taco Shell 70670-00236 El Rio Yellow 12 ct Taco Shell 35826-00660 Food Lion 12 ct Taco Shell 41226-06120 Fred Meyer 12 ct Taco Shell 50700-24296 Hytop 12 ct Taco Shell 41270-02347 IGA - Celebracion 12 ct Taco Shell 71743-00651 Jimenez 12 ct Taco Shell 11110-85475 Kroger 12 ct Taco Shell 99614-61126 Kash-n-Karry 12 ct Taco Shell 70870-00671 Ole' 12 ct Taco Shell 70253-46860 Our Family/Nash Finch 12 ct Taco Shell 50700-30420 Parade 12 ct Taco Shell 41735-01567 Pricechopper 12 ct Taco Shell 11205-03640 Rainbow 12 ct Taco Shell 50700-02456 Red & White 12 ct Taco Shell 11166-05655 Richfood 12 ct Taco Shell 11150-09291 Roundy's 12 ct Taco Shell 21130-30026 Safeway 12 ct Taco Shell 21140-20555 San Carlos 12 ct Taco Shell 51933-17280 Senor Taco 12 ct Taco Shell 45674-08110 Shaw's 12 ct Taco Shell 11161-15666 Shurfine 12 ct Taco Shell 15400-86064 Shurfine/Western Family 12 ct Taco Shell 20922-30012 Tortilla King 12 ct Taco Shell 15400-00238 Western Family 12 ct Taco Shell 70378-12868 Vons 12 ct Taco Shell 41277-23409 Zapata 12 ct Taco Shell 70038-33315 Always Save 10 ct Taco Shell 41175-37734 Buena Comida 10 ct Taco Shell 41150-35146 Staff 10 ct Taco Shell 41497-75575 Weis 10 ct Taco Shell 41163-44242 Albertson's 12 ct Tostada Shells 73731-00758 Butter Krust 12 ct Tostada Shells 70670-00253 El Rio Yellow 12 ct Tostada Shells 50700-04323 Hytop 12 ct Tostada Shells 11110-85473 Kroger 12 ct Tostada Shells 70870-00673 Ole' Chalupa 12 ct Tostada Shells 11161-15669 Shurfine 12 ct Tostada Shells 20922-06000 Tortilla King 12 ct Tostada Shells 41277-23408 Zapata 12 ct Tostada Shells 41175-37735 Buena Comida 10 ct Tostada Shell 15400-02658 Western Family 10 ct Tostada Shell 42187-55006 Best Yet 12 ct Taco Dinner 007552-306006 Campbells 6 ct 12 ct Taco Dinner 37600-40413 Chi Chi's Hormel 12/10 ct Dinner 70670-00240 El Rio Yellow Dinner 12 ct Taco Dinner 70670-00226 El Rio Yellow Kit 10 ct Taco Dinner 35826-00661 Food Lion 12 ct Taco Dinner 50700-26397 Hytop 12 ct Taco Dinner 41270-02348 IGA - Celebracion 12 ct Taco Dinner 11110-85474 Kroger 12 ct Taco Dinner 99614-61116 Kash-n-Karry 12 ct Taco Dinner 70253-46862 Our Family/Nash Finch 12 ct Taco Dinner 50700-08716 Parade 12 ct Taco Dinner 41735-01566 Pricechopper 12 ct Taco Dinner 11205-03645 Rainbow 12 ct Taco Dinner 50700-02455 Red & White 12 ct Taco Dinner 11166-05656 Richfood 12 ct Taco Dinner 21140-20556 San Carlos 12 ct Taco Dinner 51933-10730 Senor Taco 12 ct Taco Dinner 45674-08111 Shaw's 12 ct Taco Dinner 11161-15667 Shurfine 12 ct Taco Dinner 41497-75578 Weis 10 ct 10 ct Taco Dinner 41163-44244 Albertson's 12 ct Jumbo Shell 70670-00298 El Rio Yellow 12 ct Jumbo Shell 50700-06015 Hytop 12 ct Jumbo Shell 11110-85472 Kroger 12 ct Jumbo Shell 41226-06135 Fred Meyer Super Size 10 ct Jumbo Shell 15400-00201 West Family Super Size 10 ct Jumbo Shell c) Tostadas: 73731-00760 Mission Tostada Casero 48564-22019 Guerrero Tostada Casera 48564-00115 Guerrero Tostada Plana 10 ct 48564-02107 Guerrero Tostada Plana 20ct 90179-10012 El Maizal Tostada 90179-01889 El Maizal Tostada Casero 90179-10010 El Maizal Tostada Casera 90179-00079 Tapatio Tostada Casera d) Chips: 73731-00637 Mission 40 oz Yellow Tortilla Rounds 73731-00659 Mission 20 oz Restaurant Style 73731-00660 Mission 20 oz Natural Rounds 73731-00641 Mission 7.5 oz Salsa Chips 73731-03207 Mission 4 lb Round Chips 73731-00574 Mission 48 oz Restaurant Yellow Tri 73731-00573 Mission 48 oz Yellow Rounds 77948-42003 Calidad 40 oz Nacho Chips 77948-24503 Calidad 40 oz Restaurant Chips 77948-24505 Calidad 20 oz Restaurant Style 77948-24506 Calidad 20 oz Nacho Chips 90179-01890 El Maizal 15 oz Yellow Triangle 70343-00403 Diane's 12 oz Nacho Chips 70343-00408 Diane's 14 oz Yellow Rounds 70343-00410 Diane's 32 oz BB Round 70343-00423 Diane's 20 oz Jumbo Nacho 70343-00428 Diane's 20 oz Jumbo Yellow Round 70343-00615 Diane's 16 oz BB Rounds 41512-99041 Montecito 5 lb Yellow Rounds 41512-99042 Montecito 5 lb Yellow Triangles 41512-99043 Montecito 5 lb Nacho Cheese 41512-02236 Montecito 2 lb Yellow Rounds 41512-02238 Montecito 2 lb Yellow Triangles 46392-05101 Southwest 13 oz Browns (Rounds) 46392-05102 Southwest 13 oz Nacho (# 349) 75604-04473 La Fiesta 3/2 lb Yellow Rounds 48564-00116 Guerrero Casero Chips 41163-65119 Albertson's 14.5 oz Yellow Rounds 41163-00620 Albertson's Round Tortilla Chip 73731-00706 El Pueblo (Alb.) 14 oz Yellow Chip 51022-40998 Fiesta Mart 16 oz Yellow Rounds 51022-40999 Fiesta Mart 40 oz Yellow Rounds 41634-00463 Rosauers Nacho Tortilla Chip 70343-00473 Haggens Nacho Tortilla Chip 35833-07506 Best Buy 15 oz Yellow Triangle (#3340) 35833-07516 Best Buy 15 oz Yellow Triangle Unsalt (#3341) 35833-07511 Best Buy 8 oz Yellow Triangle (#3343) 35833-07520 Best Buy 48 oz Yellow Rounds (#3345) 35833-07646 Best Buy 15 oz Yellow Triangles 35833-17506 Best Buy 15 oz Yellow Rounds (#3408) 35833-17520 Best Buy 2/48 oz Yellow Triangles (#3409) 35833-07643 Best Buy 2/48 oz Yellow Triangles (#3421) 35833-07647 Best Buy 48 oz Restaurant Yellow Tri (#3372) 35833-17643 Best Buy 2/48 oz Yellow Rounds (#3410) 86313-77771 Big 8 15 oz Yellow Chips (# 3472) 86313-77773 Big 8 32 oz Yellow Chips (# 3473) 35833-81901 Food City 32 oz Yellow Chips 35833-46180 Price Rite 32 oz Yellow Chips 41260-26040 FRYS Golden Chips 14 oz 41260-26044 FRYS Original Chips 14 oz 41260-26043 FRYS 12 oz Nacho Chips 21130-11865 Safeway 14 oz Golden Chip 21130-11864 Safeway 14 oz Nacho Chip (# 160) 31903-00003 Bashas 14 oz Golden Chip 31903-00040 Bashas 14 oz Nacho Round 31903-00235 Fiesta 13 oz Nacho Round (#1297) 73731-00544 Rancho Grande 14 oz Golden Chip 73731-00600 Rancho Grande 14 oz Nacho Chip 46145-00801 Minyard 12 oz Nacho Chips 46145-00538 Sack'n Save 16 oz Nacho Chips 46145-00539 Carnival 16 oz Nacho Chips 71743-00032 Jimenez 32 oz Yellow Chips 70738-08542 Vons 12 oz Yellow Nacho Strip 41175-08227 Ralphs 12 oz Nacho Chips 41226-19445 Fred Meyer 15 oz Nacho Chips 41226-19425 Fred Meyer 15 oz Original Round 15400-83893 Western Shurfine Yellow Nacho Chip 70273 15400-83892 Western Shurfine Yellow Nacho Chip 70274 15400-85553 Western Shurfine Yellow Nacho Chip 70275 15400-85554 Western Shurfine Yellow Nacho Chip 70276 15400-85555 Western Shurfine Yellow Nacho Chip 70277 71743-00032 Generic 3/2 # Yellow Nacho 60032 50700-06016 Hy-Top 3/2 # Yellow Nacho 60016 73731-00635 Butter Krust Yellow Nacho 60635 75604-03217 Fiesta Brand Yellow Nacho 63229 Clear spot label Parade 6-20 oz Yellow Nacho 60561 Food Service Item Code Description Category Brand 5501 Mesa Tortilla Corn Applebees 10811 Yellow Round Chip 3/2 # Chips BEK 10111 5.25" Taco Shell Shell BEK 10846 Yellow Tri Chip 1/12 # - Calif. Chips Casa Solana 10847 Round Yellow Chip 1/12 # - Calif. Chips Casa Solana 10994 Yellow Tri Chip7 cut - 2/3 # - Diane's Chips Casa Solana 11004 Yellow Round Chip 3/2 # Chips Casa Solana 11005 Yellow Tri Chip 3/2 # Chips Casa Solana 10552 6" Yellow Corn Tortilla 6 oz/dz Corn Casa Solana 10938 PCUF Yellow Chip 4 cut PCUF Chip Casa Solana 10114 5" Yellow Taco Shell Shell Casa Solana 10159 Casa Solana Tostada Shell 200 ct 6 in Tostada Casa Solana 10941 6/1 lb Del Taco Yellow Chips Chips Del Taco 04216 5.5" Taco Shell Shell Del Taco 6422 Yellow Round Chip 3/2 # Chips Famosa 6424 Yellow Triangle Chip 4-cut 3/2 # Chips Famosa 6428 6" Yellow Corn Tortilla 6 oz/dz Corn Famosa 6429 PCUF Yellow Chip 6 cut PCUF Chip Famosa 6427 PCUF Yellow Chip 4 cut PCUF Chip Famosa 10815 La Cantina Regular Ylw Tri Chip 12/1 Chips La Cantina 10816 La Cantina Unsalted Ylw Tri Chip 12 Chips La Cantina 10506 La Cantina Ylw Corn 12/60ct 6oz 6in Corn La Cantina 10954 La Cantina Unfried Ylw Tri Chip 1/30 PCUF Chip La Cantina 10959 La Cantina Unfried Ylw Tri Chip 1/30 PCUF Chip La Cantina 03174 5.75 CRYL LMSP 6/120 45.0T 5.0M Corn La Monita 03185 5.75 CRYL REGL 6/100 62.3T 8.0M Corn La Monita 03165 4CUTUCWH LMON 1/25 25 LBT 4.5M PCUF Chip La Monita 03251 6/1 lb Salted Yellow Chips- Calif. Chips Mission 10820 Yellow Tri Chip 7 cut - 2/3 # Chips Mission 10822 Yellow Round Chip Chips Mission 10852 Yellow Tri Chip 7 cut 1/12 # Chips Mission 10873 Yellow Tortilla Chip 2/3 # Club pack Chips Mission 10874 Yellow Tortilla Chip 2/3 # Club pack Chips Mission 10899 3/2 lb F.S. Yellow Rest. Chips - Calif. Chips Mission 10914 Yellow Round Chip-unsalted 3/2 # Chips Mission 11009 Tri Color Triangle Chip 3/2 # Chips Mission 11039 3/2 lb F.S. Golden Strips - Calif. Chips Mission 11828 Yellow Round Chip-enriched 3/2 # Chips Mission 11831 Yellow Tri Chip-enriched Chips Mission 05311 Yellow Round Chip, Portion Pack 36/3 oz w/Trays Chips Mission 10823 Yellow Round no Salt 3/2 # Chips Mission 10853 Yellow Round Chip 1/12 # Chips Mission 11832 Yellow Round Chip-enriched no Salt Chips Mission 10800 Yellow Round Chip Chips Mission 10801 Yellow Tri no Salt Chips Mission 10802 Yellow Tri Chip Chips Mission 10808 Yellow Round 6/1 # Chips Mission 10830 Yellow Round, Portion Pak 36/4oz-plain bag Chips Mission 10831 Yellow Round, Portion Pak 48/30 oz Chips Mission 10606 6" Yellow Corn Tortilla light & crispy Corn Mission 10520 6" Yellow Corn Tortilla 10 oz/dz Corn Mission 10524 6" Yellow Corn Tortilla 13 oz/dz 6/60 ct Corn Mission 10541 4" Yellow Corn Tortilla 4.5 oz/dz Corn Mission 11602 5.5" Yellow Corn Tortilla 5.5 oz/dz Corn Mission 10503 6" Yellow Corn Tortilla 5 oz/dz Corn Mission 10505 6" Yellow Corn Tortilla 6 oz/dz Corn Mission 10510 6" Yellow Corn Tortilla 7 oz/dz Corn Mission 10527 6" Yellow Corn Tortilla 12 oz/dz Corn Mission 10530 6" Yellow Corn Tortilla 14 oz/dz Corn Mission 03143 Msn Unfried Ylw Tri Chip 3 cut 3.9 oz/dz PCUF Chip Mission 10865 Precut Unfried Chip Tort-Yellow PCUF Chip Mission 04081 PCUF Yellow Strips PCUF Chip Mission 10868 PCUF Yellow 4 cut thin PCUF Chip Mission 10859 PCUF Yellow 4 cut PCUF Chip Mission 10854 PCUF Yellow 6 cut PCUF Chip Mission 11705 5.50SHYL TICO 10/20 5.57 5.28M Shell Mission 11717 FS 8" 1/200 Jumbo Taco Shell Mission 11718 FS 5.5" 10/20 Taco LT Shell Mission 10102 FS 4" 12/24 Mini Taco Shell Mission 10104 5 1/8 200 ct Taco Shell - Calif. Shell Mission 10110 Msn Taco Shell 200 ct 5.5 in. Shell Mission 10120 Bulk Taco Shell A-1 1/200 ct Shell Mission 10573 BOW SHYL FSTA 8/25 Shell Mission 10105 5" Regular Taco Shell Shell Mission 10112 7" Grande Taco Shell Shell Mission 10115 6" Large Taco Shell Shell Mission 11714 FS 5.5" 1/200 Tostada LT Tostada Mission 10160 Tostada Shell Tostada Mission 10818 Mr. Nacho Round Chips Chips Mr. Nacho 10817 Yellow Tri Chip 3/2 # Chips Primavera 10906 Yellow Round Chip 3/2 # Chips Primavera 10917 Yellow Round Chip 1/12 # Chips Primavera 10932 Yellow Tri Chip 1/12 # Chips Primavera 3281 6" Yellow Corn Tortilla 6 oz/dz Corn Que Grande 03283 FS Que Grande Ylw Rnd Chips 6/1 lb Chips Que Grande 03286 FS Que Grande Ylw Rnd Chips 3/2 lb Chips Que Grande 11012 Shamrock Ylw Rnd Chip 3/2 lb Chips Shamrock 11013 Shamrock Ylw Tri Chip 3/2 lb Chips Shamrock 10518 6" Yellow Corn Tortilla 7 oz/dz Corn Shamrock 10158 Shamrock Taco Shell 1/200ct 5in Shell Shamrock 10181 Shamrock Tostada Shell 1/200ct 5in Tostada Shamrock 10945 Yellow Round Chip 3/2 # Chips Sr. Carlos 03287 FS Sunday Dinner Ylw Rnd Chips 3/2 lb Chips Sunday Dinner 10805 Yellow Round Chip 3/2 # Chips Walmart 03131 Wendys Ylw Round Chip 48/1.5oz Chips Wendys 73731-06197 6" Yellow Corn Tortilla 10 oz/dz Corn United Grocers 73731-06198 6" Yellow Corn Tortilla 7 oz/dz Corn United Grocers. CODE All product on the market at the time of recall initiation. MANUFACTURER Mission Foods, Dallas, Texas. RECALLED BY Mission Foods, Irving, Texas, by press release on October 13, 2000, and by letters on October 13 and 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON The products appear to contain Bacillus thuringiensis subspecies tolworthi Cry9C protein and the genetic material necessary for its production in corn (trade name: StarLink)- a pesticide which is not allowed for use in foods for human consumption.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Various flavors of smoked salmon: a) Smoked Wild Salmon (regular flavor); b) Garlic Smoked Wild Salmon; c) Cajun Smoked Wild Salmon; d) Garlic Pepper Smoked Wild Salmon. Recall #F-015/018-1. CODE All product distributed prior to 9/6/00. MANUFACTURER C&H Classic Smoked Fish, Cathlamet, Washington. RECALLED BY Manufacturer, by visit between September 7 and 12, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY Firm estimates none remains on the market. REASON Products contained undeclared FD&C Red No. 40.RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
________ PRODUCT Artrain brand Face Paints, 6 colors and a brush on a card. Recall #F- 013-1. CODE None. MANUFACTURER Undetermined. Product of China. RECALLED BY Dollar Plus, Inc., Everett, Washington, by telephone on or about August 28, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 5 cases (48 cards per case) were distributed. REASON Product contained the following undeclared and uncertified color additives: sunset yellow FCF (certifiable as FD&C Yellow No. 6 - not allowed for coloring cosmetics intended for use in the area of the eye), tartrazine (certifiable as FD&C Yellow No. 5), and allura red AC (certifiable as FD&C Red No. 40).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-093-1. CODE Unit #18FK35365. MANUFACTURER American Red Cross Blood Services, Lansing, Michigan. RECALLED BY Manufacturer, by letter on February 14, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. 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 Platelets. Recall #B-106-1. CODE Unit Numbers: 8946012 and 3140247. MANUFACTURER Florida-Georgia Blood Alliance, Jacksonville, Florida. RECALLED BY Manufacturer, by telephone on March 26, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Platelets, Pheresis. Recall #B-126-1. CODE 5305832, 5305944, 5305945, 5305947 (split products) MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, Tennessee. RECALLED BY Manufacturer, by letter dated November 7, 1998. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 4 split units were distributed. REASON Blood products had unacceptable platelet concentrations. ________ PRODUCT Platelets. Recall #B-142-1. CODE Unit #13FR14499. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on March 11, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of red blood cells which tested positive for Staphylococcus aureus and was implicated in a febrile transfusion reaction. ________ PRODUCT Red Blood Cells. Recall #B-143-1. CODE Unit #13GC62153. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated November 27, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving post donation information that the donor was diagnosed with mononucleosis. ________ PRODUCT Sepacell(r) Pre-storage Leukocyte Reduction Set. Recall #B-148-1. CODE All lot numbers beginning with A00E, A00F, A00G, A00H. MANUFACTURER Baxter S.A., Fenwal Division, Parque Industrial Itabo, Zona Franca Industrial de Haina, San Cristobal, Republica Dominica. RECALLED BY Baxter Healthcare Corporation, Fenwal Division, Deerfield, Illinois, by telephone and letter on September 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Brazil, Venezuela, Chile, Belgium. QUANTITY 678,309 units were distributed, with the firm estimating that 20% of the product remains on the market. REASON Leukocyte reduction filter sets were occasionally leaking during the leukoreduction of units of Red Blood Cells intended for transfusion. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Plasma; e) Cryoprecipitated AHF. Recall #B-149/153-1. CODE Unit Numbers: a) 03FJ51705, 03FX11152, 03FX11153, 03GF54383, 03GG56390, 03GG56511, 03GL40935, 03GN27088, 03GR45911, 03GZ11572, 03LG10617; b) 03GF54383, 03GR45911; c) 03GG56390, 03GL40935, 03GR45911; d) 03FF57025, 03GZ12145, 03GZ11572; e) 03GZ11572. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone or letter on February 16, 23 and 26 1999, March 4, 17 or 18, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY a) 11 units; b) 2 units; c) 3 units; d) 3 units; e) 1 unit. REASON Blood products were prepared from overweight whole blood units. ________ PRODUCT Platelets. Recall #B-154-1. CODE Unit #7039272. MANUFACTURER New York Blood Services (Center West), A Division of New York Blood Center, Inc., New York, New York. RECALLED BY Manufacturer, by letter dated June 12, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product tested CMV positive was distributed labeled as CMV negative. ________ PRODUCT Whole Blood, Autologous. Recall #B-156-1. CODE Unit 18222-9234. MANUFACTURER United Blood Services, Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 24, 2000. Firm-initiated recall complete. DISTRIBUTION Colorado. QUANTITY 1 unit was distributed. REASON Autologous blood product was collected from a donor who reported taking antibiotics for an infection. ________ PRODUCT Red Blood Cells. Recall #B-157-1. CODE Unit #4763335. MANUFACTURER National Naval Medical Center, Bethesda, Maryland. RECALLED BY Manufacturer, by letter dated October 13, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for anti-HCV and was not retested in duplicate. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-158-1. CODE Unit #15006-7928. MANUFACTURER Blood Systems, Inc., Texas Blood Institute - Lubbock Center, Lubbock, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated November 24, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was taking the drug Methotrexate. ________ PRODUCT Platelets, Pheresis, Leukoreduced. Recall #B-159-1. CODE Unit #15009-3782. MANUFACTURER Blood Systems, Inc., Texas Blood Institute - Lubbock Center, Lubbock, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 5, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count was labeled as a standard product.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Fresh Frozen Plasma. Recall #B-084-1. CODE Unit #E24289. MANUFACTURER Carolina-Georgia Blood Center, Greenville, South Carolina. RECALLED BY Manufacturer, by telephone on July 14, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product was not frozen within 8 hours of whole blood collection. ________ PRODUCT a) Panocell-10 Ficin Treated, Reagent Red Blood Cells b) Panocell-10 Reagent Red Blood Cells. Recall #B-108-1. CODE a) Lot 48737E; b) Lot 48737. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by letter dated December 16, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide, Canada, Italy, Germany, England, Belgium. QUANTITY a) 232 sets; b) 603 sets were distributed. REASON Reagent red blood cells were positive for the Jsa antigen, were identified on the antigen profile sheet as Jsa negative. ________ PRODUCT Source Plasma. Recall #B-144-1. CODE Unit #0054771. MANUFACTURER DCI Biologicals Carbondale, Inc., Carbondale, Illinois. RECALLED BY Manufacturer, by fax on May 11, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who previously had an elevated ALT on two separate occasions. ________ PRODUCT Recovered Plasma for manufacture of non-injectable products. Recall #B- 146-1. CODE Unit #13W98469. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on February 24, 2000. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the HIV-1 p24 antigen, but was collected from a donor who subsequently tested repeatedly reactive for the HIV-1 p24 antigen. ________ PRODUCT Red Blood Cells. Recall #B-147-1. CODE Unit #81-31327. MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan, by letter dated August 27, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was received at an undocumented temperature was redistributed. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-155-1. CODE Unit #FG20271. MANUFACTURER Healthcare Provider Services, doing business as Rhode Island Blood Center, Providence, Rhode Island. RECALLED BY Manufacturer, by letter dated September 22, 2000. Firm-initiated recall complete. DISTRIBUTION Rhode Island. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose hemoglobin/hematocrit results were not documented during screening. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-160-1. CODE Unit #26162-1369. MANUFACTURER Blood Systems, Inc., Fort Smith, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 3, 2000. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood product remained at room temperature for an unacceptable length of time during leukoreduction. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Irradiated; c) Platelets; d) Platelets, Irradiated; e) Fresh Frozen Plasma; f) Recovered Plasma; g) Recovered Plasma for Further Manufacture of Non- Injectable Products Only. Recall #B-165/171-1. CODE Unit Numbers: a) 13FY32442, 13FY32443, 13FY32444, 13FY32445, 13FY32446, 13FY32448, 13GC56172, 13GC56173, 13GC56174, 13GC56175, 13GC56176, 13GC56177, 13GC56178, 13GC56179 and 13GC56182 b) 13FY32447 and 13GC56180 c) 13FY32442, 13FY32443, 13FY32444, 13FY32445, 13FY32446, 13FY32447, 13FY32448, 13GC56172, 13GC56173, 13GC56175, 13GC56176, 13GC56177, 13GC56178, 13GC56179 and 13GC56180 d) 13GC56174 e) 13GC56179 f) 13FY32442, 13FY32443, 13FY32444, 13FY32445, 13FY32446, 13FY32447, 13FY32448, 13GC56172, 13GC56173, 13GC56175, 13GC56176, 13GC56177, 13GC56178, 13GC56180 and 13GC56182 g) 13GC56174. MANUFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by telephone or letter on June 29, 1998, July 1 or 2, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan, California, New York. QUANTITY a) 15 units; b) 2 units; c) 15 units; d) 1 unit; e) 1 unit; f) 15 units; g) 1 unit distributed. REASON Blood products were incorrectly tested for human immunodeficiency virus (HIV) p24 antigen.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Sigma 8000 Volumetric Infusion Pump with Version 3.29.00 Software. Recall #Z-953-0. CODE 792 serial numbers ranging from 00139 thru 58778. NOT all serial numbers within this range are affected. MANUFACTURER Sigma International, Medina, New York. RECALLED BY Manufacturer, by letter dated July 13, 2000, followed by visit beginning on July 4, 2000. Firm-initiated field correction ongoing. 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).RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ 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. Recall #Z-009-1. 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, by letter dated May 24, 2000. Firm-initiated field correction complete. 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. Recall #Z-010/011-1. 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, by telephone on January 25, 2000, followed by letter on February 22, 2000. Firm- initiated recall complete. 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. Recall Z- 012/013-1. 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. RECALLED BY Manufacturer, by letter dated August 28, 2000. Firm-initiated recall ongoing. 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. Recall #Z-014-1. CODE Catalog #195 7927, Lot Numbers 76 and 81 EXP 30 JUN 99. MANUFACTURER Ortho-Clinical Diagnostic, Inc., Rochester, New York. RECALLED BY Manufacturer, by letter dated July 31, 1998, or E-mail, fax, and letter on July 29, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 15,295 kits were distributed. REASON Quality control results were low or outside expected range on DT CK slides.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS I
________ PRODUCT Petniks Porkniks Smoked Hide Chips, pet treats, in 100-count boxes. Recall #V- 104-0. CODE 000246. MANUFACTURER Reliable Pet Products, Inc., Sioux City, Iowa. RECALLED BY Manufacturer, by visit and/or telephone on July 24, 2000, and by letter and press release on July 25, 2000. Firm-initiated recall ongoing. DISTRIBUTION Minnesota. QUANTITY 300 100-count cases were distributed. REASON Pet treats are potentially contaminated with Salmonella - This organism can cause serious illness and can sometimes be fatal. ________ PRODUCT Dried Treats, Dried Pig Ears, smoked and plain (bulk). Recall #V-105-0. CODE Product codes 10102 (plain flavor) and 10103 (smoked) on the shipping cartons, but there are no codes on immediate product packaging. Shipping cartons were labeled with the date codes (lot numbers) 4/16/00 thru 4/26/00. MANUFACTURER Carolina Prime Pet, Murphy, North Carolina. RECALLED BY Manufacturer, by fax on July 28, 2000, and by press release on August 1, 2000. Firm-initiated recall ongoing. DISTRIBUTION Texas, Louisiana, Michigan, Pennsylvania, Virginia, New Jersey, Delaware, Maryland, District of Columbia. QUANTITY 237,500 pig ears (bulk) were distributed. REASON Pet treats are potentially contaminated with Salmonella - This organism can cause serious illness and can sometimes be fatal. ________ PRODUCT Pet Carousel brand 100% Choo-Hooves Pressed Sticks, pet treats. Recall #V-106-0. CODE None, Item #90010-S. MANUFACTURER Products Carousel, Inc., Sanger, California. RECALLED BY Manufacturer, by telephone on June 1, 2000, and by press release on June 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Arizona, Nebraska, South Carolina. QUANTITY Approximately 405 2-stick packages were distributed. REASON Pet treats are potentially contaminated with Salmonella - This organism can cause serious illness and can sometimes be fatal.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS II
________ PRODUCT Mastitis kits containing recalled Clinipad alcohol prep pads: a) Cephapirin Benzathine syringes marketed under the brand names of Cefa-Dri and ToMORROW. Fort Dodge Animal Health - firm on label. b) Cephapirin Sodium syringes marketed under the brand names of Cefa-Lak and ToDAY. Fort Dodge Animal Health - firm on label. c) Dry-Clox Cloxacillin Benzathine syringes. Fort Dodge Animal Health - firm on label. d) Hetacin-K Hetacillin Potassium syringes. Fort Dodge Animal Health - firm on label. Recall #V-001/004-1. CODE Undetermined. MANUFACTURER G.C. Hanford Manufacturing Company, Syracuse, New York. RECALLED BY Fort Dodge Animal Health, Fort Dodge, Iowa, by letter mailed on March 29, 2000. Consignees were requested to remove and destroy all Clinipad alcohol preps packed with the kits. Firm-initiated recall ongoing. COMPONENT MANUFACTURER The Clinipad Corporation, Rocky Hill, Connecticut (responsible firm). DISTRIBUTION Nationwide and international. QUANTITY 5,517,329 12-syringe boxes were distributed. REASON Kits contain Clinipad products labeled as sterile. Clinipad is unable to assure the sterility.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
________ PRODUCT Liquichlor with Cerumene, Chloramphenicol-prednisolone-tetracaine suspension, topical use, for treatment of otitis exterma and pyodermas in dogs and cats. Recall #V-092-0. CODE Lot #13565 EXP 2/00. MANUFACTURER Evsco Pharmaceuticals, a division of ImmunoGenetics, Inc., Buena, New Jersey. RECALLED BY Manufacturer, by letter on September 10, 1999, followed by faxed letter dated January 12, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide, Canada, Israel. QUANTITY 74,280 10-ml tubes were distributed. REASON Stability problems.END OF ENFORCEMENT REPORT FOR NOVEMBER 1, 2000. ####
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