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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
November 8, 2006
06-45
______________________________
PRODUCT
Mini Angel Food 6-pack, 9.52 oz, UPC codes 59608-00465, 32479-20399, 32479-30350, 32479-60299, 32479-70349, 32479-80798. Packaged under brand names: a) SuperTarget and b) ARCHER FARMS. Ingredients: Water, Sugar, Wheat Starch, Enriched Wheat Flour, leavening, Calcium Phosphate, Sodium Acid Pyrophosphate, Sodium Aluminum Phosphate, Artificial Flavor, Salt, Gum Arabic, Recall # F-044-7
CODE
Sell By Dates prior to 08/15/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Target Corporation, Minneapolis, MN, issued a press release on August 7, 2006.
Manufacturer: Oak Run Bakery, Ancaster Ontario, Canada. Firm initiated recall is ongoing.
REASON
SuperTarget & Archer Farms brand Mini Angel Food cakes purchased before August 05, 2006 contain an undeclared Dried Egg White ingredient.
VOLUME OF PRODUCT IN COMMERCE
825 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Oriental King Brand dried vegetable, net wt 114g (4 oz) -- Product of China -- Ingredient: Dried Vegetable. The product is a fungus, packed in a heat-sealed, flexible plastic bag labeled in Chinese and English, Recall # F-045-7
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mon Chong Loong Trading Corp., Maspeth, NY, by press release on April 28, 2006, and by telephone on/about April 28, 2006.
Manufacturer: LIP on Trading Co, Hong Kong, China. State initiated recall is complete.
REASON
The product contained undeclared sulfites (1428 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, NJ, PA, MA, and GA
______________________________
PRODUCT
Kroger Garden Blend Frozen Fresh Stir Fry Vegetables, Broccoli, Sugar Snap Peas, Green Beans, Carrots, Celery, Water Chestnuts, Onions, and Red Peppers. Net wt. 14 oz. (396g). Keep Frozen, Recall # F-046-7
CODE
W46124/W610002
RECALLING FIRM/MANUFACTURER
Lakeside Foods, Inc., Manitowoc, WI, by telephone and letter on September 8, 2006. Firm initiated recall is ongoing.
REASON
Product contains undeclared egg noodles (egg and wheat).
VOLUME OF PRODUCT IN COMMERCE
636 cases/9 -- 14 oz. packages per case
DISTRIBUTION
IN, MI, and OH
______________________________
PRODUCT
Nacho Flavored Tortilla Chips. The product is sold under the following labels: Wise, Bravo, Moore''s, Hannaford, Giant Gustados, Stop and Shop Gustados, and Tops Gustados. The product is sold in the following size bags (by label): Wise and Bravo in 1 oz, 2 oz, 3.25 oz and 5.5. oz; Moore''s in 1 oz; Hannaford in 13 oz; Giant Gustados in 13.5 oz; Stop and Shop Gustados in 13.5 oz; and Tops Gustados in 13.5 oz. The products are shipped in cases containing (by label and size): Wise and Bravo 1 oz - 72 and 48 bags/case, Wise and Bravo 2 oz - 30 bags/case, Wise and Bravo 3.25 oz - 20 bags/case, Wise and Bravo 5.5. oz - 9 bags/case; Moore''s 1 oz - 120 bags/case; Hannaford 13 oz - 8 bags/case; Giant Gustados 13.5 oz - 6 bags/case; Stop and Shop Gustados 13.5 oz - 6 bags/case; and Tops Gustados 13.5 oz - 6 bags/case, Recall # F-047-7
CODE
Wise JAN2907, Bravo JAN2907, Moore’s JAN2907, Hannaford NOV1306, Giant Gustados NOV1306, Stop and Shop Gustados NOV1306, and TOPS Gustados NOV1306.
RECALLING FIRM/MANUFACTURER
Wise Foods, Inc., Berwick, PA, by press release on September 20, 2005. Firm initiated recall is ongoing.
REASON
Product contains undeclared soy protein isolate.
VOLUME OF PRODUCT IN COMMERCE
28,995 cases
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
Exotic Sweets brand Kaju Katli, Net wt. 14 oz. (397 grams) -- Ingredients: Cashews and Sugar. The product is packaged in a rigid plastic container, Recall # F-048-7
CODE
Code 79.06
RECALLING FIRM/MANUFACTURER
Rajbhog Foods, Flushing, NY, issued a press release on May 5, 2006 and by letters dated May 4, 2006. State initiated recall is complete.
REASON
The product contained undeclared milk based on sampling, analysis, and inspectional findings by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
112 units
DISTRIBUTION
NJ, CT, and PA
______________________________
PRODUCT
Albertsons Chocolate ice cream with a Rocky Road ice cream lid containing the following "best by date:: Aug/31/2007, 1.75 quart containers. The ice cream actually inside the container may be "Rocky Road", which contains almonds that are not listed as an ingredient on the label of the container, Recall # F-049-7
CODE
Best by Date: AUG/3/2007
RECALLING FIRM/MANUFACTURER
Dean Foods of California, Inc., Buena Park, CA, by press release and email on September 12, 2006. Firm initiated recall is ongoing.
REASON
Product may contain undeclared almonds.
VOLUME OF PRODUCT IN COMMERCE
180 units
DISTRIBUTION
AZ and CA
______________________________
PRODUCT
Nacho Flavored Tortilla Chips, packaged in cases containing various sizes of metallized plastic bags under labels: ***Laura Lynn Nacho Flavored Tortilla Chips, 13 ounce bags/ 6 count cases*** Southern Home Nacho Flavored Tortilla Chips, 13 ounce bags/ 12 count cases*** Filler Brand Nacho Flavored Tortilla Chips, 1 oz bags/ 72 count cases; 1.5 oz bags/48 count cases; and 9 oz bags/12 count cases*** Kid Connection Nacho Flavored Tortilla chips as a component in Kid Connection variety snack sacks, 1 ounce bags/ 5 bags per sack/ 7 sacks per case*** Food Lion Nacho Flavored Tortilla Chips as a component in Food Lion variety snack sacks, 1 ounce bags/4 bags per sack/ 5 sacks per case*** Food Express Cantina Style Nacho Tortilla Chips, 16 ounce bags/ 12 count cases, Recall # F-050-7
CODE
Best Buy dates prior to and including February 7, 2007 on retail packages and Julian date codes of 17706 to 19106 on bags packaged as a component in Kid Connection brand variety snack packs.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Snack Alliance, Inc., Hermiston OR, by press release on September 25, 2006.
Manufacturer: Snack Alliance, Inc., Bristol VA. Firm initiated recall is ongoing.
REASON
Snack products contain soy protein isolate which is not declared on the label. Individuals with severe sensitivity or allergies to soy protein are at increased risk of serious or life threatening allergic reactions.
VOLUME OF PRODUCT IN COMMERCE
36,600 cases
DISTRIBUTION
Nationwide and PR
______________________________
PRODUCT
ISOSORBIDE MONONITRATE 10mg TABLET, 250 count bags (NDC 61392-912-25) & 30 count boxes (NDC 61392-912-30), Rx only, Recall # D-302-7;
ISOSORBIDE MONONITRATE 120mg TABLET, 250 count bags (NDC 61392-538-25) & 30 count boxes (NDC 61392-538-30), Rx only, Recall # D-303-7;
ISOSORBIDE MONONITRATE 20mg TABLET, 250 count bags (NDC 61392-913-25) & 30 count boxes (NDC 61392-913-30), Rx only, Recall # D-304-7;
ISOSORBIDE MONONITRATE ER 30mg TABLET, 250 count bags (NDC 61392-916-25) & 30 count boxes (NDC 61392-916-30), Rx only, Recall # D-305-7;
ISOSORBIDE MONONITRATE ER 60mg TABLET, 250 count bags (NDC 61392-917-25) & 30 count boxes (NDC 61392-917-30), Rx only, Recall # D-306-7;
KLOR-CON M10, Potassium Chloride E.R., 10 mEq TABLET, 250 count bags (NDC 61392-689-25), 30 count boxes (NDC 61392-689-30) & 60 count boxes (NDC 61392-689-60), Rx only, Recall # D-307-7;
KLOR-CON M20, Potassium Chloride E.R., 20mEq TABLET, 250 count bags (NDC 61392-690-25) & 30 count boxes (NDC 61392-690-30), Rx only, Recall # D-308-7;
K-TAB, potassium chloride ER, 10mEq (750mg) TABLET, 60 count boxes (NDC 61392-900-60), Rx only, Recall # D-309-7;
LABETALOL HYDROCHLORIDE, 100mg TABLET, 250 count bags (NDC 61392-459-25) & 30 count boxes (NDC 61392-459-30), Rx only, Recall # D-310-7;
LABETALOL HYDROCHLORIDE 300mg TABLET, 250 count bags (NDC 61392-776-25) & 30 count boxes (NDC 61392-776-30), Rx only, Recall # D-311-7;
LAMICTAL (LAMOTRIGINE) 100mg TABLET, 250 count bags (NDC 61392-556-25) & 30 count boxes (NDC 61392-556-30), Rx only, Recall # D-312-7;
LEXAPRO (escitalopram oxalate) 20mg TABLET, 30 count boxes (NDC 61392-785-30), Rx only, Recall # D-313-7;
LEXAPRO (escitalopram oxalate) 5mg TABLET, 250 count bags (NDC 61392-322-25) & 30 count boxes (NDC 61392-322-30), Rx only, Recall # D-314-7;
LISINOPRIL 10mg TABLET, 250 count bags (NDC 61392-693-25) & 30 count boxes (NDC 61392-693-30), Rx only, Recall # D-315-7;
LISINOPRIL 2.5mg TABLET, 30 count boxes (NDC 61392-691-30), Rx only, Recall # D-316-7;
LISINOPRIL 20mg TABLET, 30 count boxes (NDC 61392-694-30), Rx only, Recall # D-317-7;
LISINOPRIL 30mg TABLET, 250 count bags (NDC 61392-695-25) & 30 count boxes (NDC 61392-695-30), Rx only, Recall # D-318-7;
LISINOPRIL 40mg TABLET, 250 count bags (NDC 61392-696-25), 30 count boxes (NDC 61392-696-30) & 60 count boxes (NDC 61392-696-60), Rx only, Recall # D-319-7;
LISINOPRIL/HYDROCHLOROTHIAZIDE 10mg/12.5mg TABLET, 250 count bags (NDC 61392-697-25) & 30 count boxes (NDC 61392-697-30), Rx only, Recall # D-320-7;
LISINOPRIL/HYDROCHLORIOTHIAZIDE 20mg/12.5mg TABLET, 250 count bags (NDC 61392-698-25) & 30 count boxes (NDC 61392-698-30), Rx only, Recall # D-321-7;
LITHIUM CARBONATE 150mg CAPSULE, 250 count bags (NDC 61392-539-25) & 30 count boxes (NDC 61392-539-30), Rx only, Recall # D-322-7;
LITHIUM CARBONATE 300mg CAPSULE, 250 count bags (NDC 61392-131-25) & 30 count boxes (NDC 61392-131-30), Rx only, Recall # D-323-7;
LITHIUM CARBONATE ER 300mg TABLET, 250 count bags (NDC 61392-736-25) & 30 count boxes (NDC 61392-736-30), Rx only, Recall # D-324-7;
LOPERAMIDE HYDROCHLORIDE 2mg CAPSULE, 250 count bags (NDC 61392-336-25) & 30 count boxes (NDC 61392-336-30), Rx only, Recall # D-325-7;
LORATADINE 10mg TABLET, 250 count bags (NDC 61392-562-25) & 30 count boxes (NDC 61392-562-30), Rx only, Recall # D-326-7;
LOVASTATIN 10mg TABLET, 250 count bags (NDC 61392-797-25) & 30 count boxes (NDC 61392-797-30), Rx only, Recall # D-327-7;
MECLIZINE HYDROCHLORIDE 12.5MG TABLET, 250 count bags (NDC 61392-338-25), 30 count boxes (NDC 61392-338-30) & 90 count boxes (NDC 61392-338-90), Rx only, Recall # D-328-7;
MECLIZINE HYDROCHLORIDE 25mg TABLET, 250 count bags (NDC 61392-339-25), 30 count boxes (NDC 61392-339-30), & 60 count boxes (NDC 61392-339-60), Rx only, Recall # D-329-7;
METFORMIN HYDROCHLORIDE 1000mg TABLET, 250 count bags (NDC 61392-687-25) & 30 count boxes (NDC 61392-687- 30), Rx only, Recall # D-330-7;
METFORMIN HYDROCHLORIDE 500mg TABLET, 250 count bags (NDC 61392-685-25), 30 count boxes (NDC 61392-685-30), & 60 count boxes (NDC 61392-685-60), Rx only, Recall # D-331-7;
METFORMIN HYDROCHLORIDE 850mg TABLET, 250 count bags (NDC 61392-686-25) & 30 count boxes (NDC 61392-686- 30), Rx only, Recall # D-332-7;
METFORMIN HYDROCHLORIDE ER 500mg TABLET, 250 count bags (NDC 61392-419-25) & 30 count boxes (NDC 61392-419-30), Rx only, Recall # D-333-7;
METHAZOLAMIDE 50mg TABLET, 30 count boxes (NDC 61392-890-30), Rx only, Recall # D-334-7;
METHIMAZOLE 10mg TABLET, 250 count bags (NDC 61392-450-25) & 30 count boxes (NDC 61392-450-30), Rx only, Recall # D-335-7;
METHIMAZOLE 5mg TABLET, 250 count bags (NDC 61392-571-25), & 30 count boxes (NDC 61392-571-30), Rx only, Recall # D-336-7;
METHOCARBAMOL 500mg TABLET, 250 count bags (NDC 61392-460-25), 30 count boxes (NDC 61392-460-30) & 60 count boxes (NDC 61392-460-60), Rx only, Recall # D-337-7;
METHOCARBAMOL 750mg TABLET, 250 count bags (NDC 61392-773-25) & 30 count boxes (NDC 61392-773-30), Rx only, Recall # D-338-7;
METHYLDOPA 250mg TABLET, 250 count bags (NDC 61392-184-25), 30 count boxes (NDC 61392-184-30) & 60 count boxes (NDC 61392-184-60), Rx only, Recall # D-339-7;
METOCLOPRAMIDE 10mg TABLET, 60 count boxes (NDC 61392-558-60) & 90 count boxes (NDC 61392-558-90), Rx only, Recall # D-340-7;
METOCLOPRAMIDE 5mg TABLET, 250 count bags (NDC 61392-557-25) & 30 count boxes (NDC 61392-557-30), Rx only, Recall # D-341-7;
METOPROLOL TARTRATE 100mg TABLET, 250 count bags (NDC 61392-280-25), 30 count boxes (NDC 61392-280-30) & 60 count boxes (NDC 61392-280-60), Rx only, Recall # D-342-7;
METOPROLOL TARTRATE 25mg TABLET, 250 count bags (NDC 61392-285-25), 30 count boxes (NDC 61392-285-30) & 60 count boxes (NDC 61392-285-60), Rx only, Recall # D-343-7;
METOPROLOL TARTRATE 50mg TABLET, 30 count boxes (NDC 61392-286-30) & 60 count boxes (NDC 61392-286-60), Rx only, Recall # D-344-7;
METRONIDAZOLE 250mg TABLET, 250 count bags (NDC 61392-397-25), 30 count boxes (NDC 61392-397-30), & 60 count boxes (NDC 61392-397-60), Rx only, Recall # D-345-7;
45) METRONIDAZOLE 500mg TABLET, 250 count bags (NDC 61392-399-25), 30 count boxes (NDC 61392-399-30) & 60 count boxes (NDC 61392-399-60), Rx only, Recall # D-346-7;
MIDODRINE 2.5mg TABLET, 250 count bags (NDC 61392-816-25) & 30 count boxes (NDC 61392-816-30), Rx only, Recall # D-347-7;
MINOXIDIL 2.5mg TABLET, 250 count bags (NDC 61392-461-25), 30 count boxes (NDC 61392-461-30), 60 count boxes (NDC 61392-461-60) & 90 count boxes (NDC 61392-461-90), Rx only, Recall # D-348-7;
MIRTAZAPINE 15mg TABLET, 250 count bags (NDC 61392-456-25) & 30 count boxes (NDC 61392-456-30), Rx only, Recall # D-349-7;
MIRTAZAPINE 30MG TABLET, 250 count bags (NDC 61392-457-25) & 30 count boxes (NDC 61392-457-30), Rx only, Recall # D-350-7;
MIRTAZAPINE 7.5mg TABLET, 250 count bags (NDC 61392-451-25) & 30 count boxes (NDC 61392-451-30), Rx only, Recall # D-351-7;
MUCINEX 600mg TABLET, 250 count bags (NDC 61392-483-25), & 30 count boxes (NDC 61392-483-30), Recall # D-352-7;
NABUMETONE 750mg TABLET, 250 count bags (NDC 61392-772-25) & 30 count boxes (NDC 61392-772-30), Rx only, Recall # D-353-7;
NALTREXONE 50mg TABLET, 250 count bags (NDC 61392-466-25), 30 count boxes (NDC 61392-466-30) & 60 count boxes (NDC 61392-466-60), Rx only, Recall # D-354-7;
NAPROXEN 250mg TABLET, 250 count bags (NDC 61392-289-25) & 30 count boxes (NDC 61392-289-30), Rx only, Recall # D-355-7;
NAPROXEN 375mg TABLET, 250 count bags (NDC 61392-292-25), 30 count boxes (NDC 61392-292-30) & 60 count boxes (NDC 61392-292-60), Rx only, Recall # D-356-7;
NAPROXEN 500mg TABLET, 250 count bags (NDC 61392-295-25) & 30 count boxes (NDC 61392-295-30), Rx only, Recall # D-357-7;
NIFEDIAC ER 30mg TABLET, 250 count bags (NDC 61392-484-25) & 30 count boxes (NDC 61392-484-30), Rx only, Recall # D-358-7;
NIFEDIAC ER 60mg TABLET, 250 count bags (NDC 61392-485-25) & 30 count boxes (NDC 61392-485-30), Rx only, Recall # D-359-7;
NIFEDIAC ER 90mg TABLET, 250 count bags (NDC 61392-486-25) & 30 count boxes (NDC 61392-486-30), Rx only, Recall # D-360-7;
NIFEDIPINE 10mg CAPSULE, 250 count bags (NDC 61392-356-25), 30 count boxes (NDC 61392-356-30) & 60 count boxes (NDC 61392-356-60), Rx only, Recall # D-361-7;
NIFEDIPINE ER 30mg TABLET, 250 count bags (NDC 61392-995-25) & 30 count boxes (NDC 61392-995-30), Rx only, Recall # D-362-7;
NIFEDIPINE ER 60mg TABLET, 250 count bags (NDC 61392-645-25) & 30 count boxes (NDC 61392-645-30), Rx only, Recall # D-363-7;
NIFEDIPINE ER 90mg TABLET, 250 count bags (NDC 61392-646-25) & 30 count boxes (NDC 61392-646-30), Rx only, Recall # D-364-7;
NITROFURANTOIN 50mg CAPSULE, 30 count boxes (NDC 61392-639-30), Rx only, Recall # D-365-7;
NITROFURANTOIN MACR 100mg CAPSULE, 30 count boxes (NDC 61392-734-30), Rx only, Recall # D-366-7;
NITROFURANTOIN MACR 50mg CAPSULE, 250 count bags (NDC 61392-639-25), Rx only, Recall # D-367-7;
NITROFURANTOIN MONOHYDRATE 100mg CAPSULE, 250 count bags (NDC 61392-494-25) & 30 count boxes (NDC 61392-494-30), Rx only, Recall # D-368-7;
NITROGLYCERIN EXTENDED RELEASE 2.5mg CAPSULE , 250 count bags (NDC 61392-640-25) & 30 count boxes (NDC 61392-640-30), Rx only, Recall # D-369-7;
NITROGLYCERIN EXTENDED RELEASE, 6.5mg CAPSULE, 250 count bags (NDC 61392-641-25) & 30 count boxes (NDC 61392-641-30), Rx only, Recall # D-370-7;
NORTRIPTYLINE 10mg CAPSULE, 250 count bags (NDC 61392-361-25), 30 count boxes (NDC 61392-361-30), Rx only, Recall # D-371-7;
NORTRIPTYLINE 25mg CAPSULE, 250 count bags (NDC 61392-364-25) & 30 count boxes (NDC 61392-364-30), Rx only, Recall # D-372-7;
NORTRIPTYLINE 50mg CAPSULE, 250 count bags (NDC 61392-367-25) & 30 count boxes (NDC 61392-367-0), Rx only, Recall # D-373-7;
NORVASC 5mg TABLET, 30 count boxes (NDC 61392-711-30), Rx only, Recall # D-374-7;
OXYBUTYNIN 5mg TABLET, 250 count bags (NDC 61392-138-25), 30 count boxes (NDC 61392-138-30), & 60 count boxes (NDC 61392-138-60), Rx only, Recall # D-375-7;
PAROXETINE 10mg TABLET, 250 count bags (NDC 61392-404-25) & 30 count boxes (NDC 61392-404-30), Rx only, Recall # D-376-7;
PAROXETINE 30mg TABLET, 250 count bags (NDC 61392-406-25) & 30 count boxes (NDC 61392-406-30), Rx only, Recall # D-377-7;
PAROXETINE 30mg TABLET, 250 count bags (NDC 61392-406-25) & 30 count boxes (NDC 61392-406-30) Rx only, Recall # D-378-7;
PAROXETINE 40mg TABLET, 250 count bags (NDC 61392-407-25) & 30 count boxes (NDC 61392-073-), Rx only, Recall # D-379-7;
PENTOXIFYLLINE 400mg ER TABLET, 250 count bags (NDC 61392-833-25), Rx only, Recall # D-380-7;
PERPHENAZINE 2mg TABLET, 250 count bags (NDC 61392-082-25) & 30 count boxes (NDC 61392-082-30), Rx only, Recall # D-381-7;
PERPHENAZINE 4mg TABLET, 250 count bags (NDC 61392-081-25) & 30 count boxes (NDC 61392-081-30), Rx only, Recall # D-382-7;
PERPHENAZINE 8mg TABLET, 30 count boxes (NDC 61392-084-30), Rx only, Recall # D-383-7;
PHENYTOIN SODIUM 100mg CAPSULE, 250 count bags (NDC 61392-937-25), Rx only, Recall # D-384-7;
PLARETASE 8000mg TABLET, 250 count bags (NDC 61392-775-25) & 30 count boxes (NDC 61392-775-30), Rx only, Recall # D-385-7;
POTASSIUM CHLORIDE 10mEq CAPSULE, 250 count bags (NDC 61392-402-25), 30 count boxes (NDC 61392-402-30) & 60 count boxes (NDC 61392-402-60), Rx only, Recall # D-386-7;
POTASSIUM CHLORIDE ER 8mEq TABLET, 250 count bags (NDC 61392-403-25), 30 count boxes (NDC 61392-403-30) & 60 count boxes (NDC 61392-403-60), Rx only, Recall # D-387-7;
PRAVASTATIN 20mg TABLET, 250 count bags (NDC 61392-368-25) & 30 count boxes (NDC 61392-368-30), Rx only, Recall # D-388-7
CODE
K38044A25, K38167C25, K41715A25, K42163A25, K38167B25, K38044B30, K38167A30, K39017A30, K39017B30, K40433A30, K41155A30, K41715B30;
K40648R25, K41098R25, K41806R25, K42172R25, K42801R25, K43383R25, K40648R30, K41098R30, K41783R30, K41806R30, K42172R30, K42801R30, K43383R30;
K38469A25, K40469A25, K41013A25, K38096A30, K38469B30, K38469C30, K38881A30, K38881B30, K39973A30, K40469B30, K41013B30, K41154A30;
K40763R25, K41112R25, K41913R25, K42176R25, K42838R25, K40763R30, K41112R30, K41913R30, K42176R30, K42370R30, K42177R30, K42838R30;
K41162R25, K41914R25, K42499R25, K42837R25, K41162R30, K41914R30, K42306R30, K42499R30, K42837R30;
K35533A25, K36014A25, K36014C25, K35533B30, K36014B30, K36014D60;
K35904A25, K36290B25, K37107B25, K37424B25, K38150B25, K41596A25, K42151A25, K42556A25, K42557A25, K38385B25, K38901A25, K39711A25, K40528A25, K35347A30, K35680A30, K35904B30, K36290A30, K36290C30, K36290D30, K36664A30, K36664B30, K36902A30, K36902B30, K37108A30, K37107A30, K37107C30, K37424A30, K37424C30, K37825A30, K37825B30, K38150A30, K41503A30, K41596B30, K41736A30, K41866A30, K42001A30, K42115A30, K42151B30, K42195A30, K42196A30, K42556B30, K42557B30, K39711C30, K42941A30, K38385A30, K38385C30, K38385D30, K38901B30, K38993A30, K38993B30, K36291D30, K39711B30, K39797A30, K40166A30, K40367A30, K40367B30, K40367C30, K40528B30, K40921A30, K41221A30;
K41014A60;
K36806B25, k38070A25, K38546B25, K38996B25, K40521A25, K36806A30, K36806C30, K37406A30, K37581A30, K37581B30, K637820a30, K38546A30, K38546C30, K42465A30, K38996A30, K38996C30;
K37275R25, K37540R25, K41572A25, K38234R25, K38820A25, K37275R30, K37540R30, K41572B30, K42118A30, K39509A30, K39509B30, K38234R30, K38820B30, K40898A30, K41032A30;
K42114R25, K42321R25, K42938R25, K42114R30, K42321R30, K42336R30, K42938R30;
K41795R30, K41999R30, K42498R30;
K42889R25, K42575R30, K42889R30, K42888R30;
K42494A25, K37067A30;
K37066A30, K38341A30, K38525A30, K40355A30;
K37062A30;
K36947A25, K38233A25, K38793B25, K41857A25, K40922A25, K40922B25, K36947B30, K38793C30, K41857B30, K40223A30, K40783A30, K40922C30;
K35614A25, K36420B25, K36420C25, K35614C30, K35614E30, K36420A30, K36765A30, K36904B30, K35614D60, K36904A60;
K36901A25, K36901C25, K38077B25, K41818A25, K40418A25, K36901B30, K36901D30, K38077A30, K38077C30, K38549A30, K38549B30, K39695A30, K40418B30, K40608A30, K40608B30;
K36808A25, K36808C25, K39950A25, K41288A25, K36404A30, K36808B30, K37462A30, K38078A30, K38954A30, K39950B30, K41115A30, K41288B30;
K40934R25, K41356R25, K41745R25, K42268R25, K43142R25, K43451R25, K40934R30, K40935R30, K41356R30, K41745R30, K42268R30, K43142R30, K43451R30;
K40911R25, K41499R25, K41756R25, K42250R25, K42977R25, K43380R25, K40911R30, K41499R30, K41756R30, K42250R30, K42977R30, K43380R30;
K41476R25, K42056R25, K42396R25, K42638R25, K43233R25, K41476R30, K42056R30, K42396R30, K43233R30;
K40918A25, K38593A30, K39866A30, K40918B30;
K38090A25, K41823A30, K41535A30;
K40068R25, K40682R25, K41101A25, K42148B30, K40068R30, K40682R30, K41101A30;
K35705A25, K35705C25, K37402A25, K38185A25, K41530A25, K39893A25, K39893B25, K35705D30, K37402B30, K38185B30, K41530B30, K42562A30, K35705B90;
K33936A25, K37401A25, K38976B25, K33936A30, K37401B30, K38976D30, K39487A30, K40220A30, K40488A30, K33936A60, K36772A60, K38976A60, K38976C60;
K34995A25, K34995B25, K36094A25, K36094C25, K36583B25, K41422A25, K37570B25, K38516A25, K38866B25, K39352A25, K39974B25, K40835B25, K35352A30, K35352B30, K36094B30, K36583A30, K36583C30, K36583D30, K41422B30, K42121A30, K37570A30, K38055A30, K38055B30, K42963B30, K43028A30, K38516B30, K38516C30, K38866A30, K39352B30, K39974A30, K39974C30, K39974D30, K40835A30, K40835C30;
K37094a25, K38980A25, K37457A30, K39138A30, K36703A60, K39138B60;
K34642A25, K34642B25, K35531A25, K36292B25, K36292C25, K36292E25, K36292G25, K39720A25, K37755B25, K41502A25, K43192A25, K39823A25, K39823C25, K40892A25, K41116A25, K34642A30, K34642C30, K35378A30, K35531B30, K36292A30, K36292D30, K36292F30, K36292H30, K37072A30, K37755A30, K37755C30, K41502B30, K38548A30, K38548B30, K38865A30, K39823B30, K39823D30, K40417A30, K40892B30;
K36265A25, K36844B25, K36844C25, K38106B25, K38796A25, K39924A25, K40834A25, K40834C25, K40834X25, K36265B30, K36844A30, K36844D30, K38106A30, K38106C30, K38502A30, K38796B30, K39924B30, K40119A30, K40119B30, K40277A30, K40277B30, K40834B30, K40834D30;
K36112A30, K36112B30, K36112C30, K38880A30, K38880B30, K39873A30, K39873B30, K41040A30;
K43060R25, K43060R30;
K36309A25, K41730A25, K38164B25, K39503A25, K40466A25, K42961A30, K36309A30, K41536A30, K37088A30, K37088B30, K38164A30, K38164C30, K39503A30, K40466B30;
K35079R25, K35829R25, K36521R25, K36880R25, K37187R25, K37523A25, K41532A25, K38071A25, K35079R30, K35829R30, K36521R30, K36880R30, K37187R30, K37523A30, K41532B30, K38538A30, K38538B30, K42699A30, K35079R60, K35829R60;
K39194R25, K40470A25, K42545B30, K39194R30, K40470B30;
K41577A25, K38773A25, K39655B25, K40977A25, K35357B30, K35357C30, K41577B30, K38063A30, K38063B30, K38773B30, K39655A30, K39655D30, K40977B30, K35357A60;
K41152A60, K42332A90;
K38032R25, K38032R30;
K35764R25, K35764R30, K36804A30, K42333A30, K38609A30, K35764R60;
K37104A25, K42622A25, K41865A30, K38675A30, K38169A60, K41224A60;
K39432A30, K40523B30, K35817R60, K38148A60, K40523A60;
K36344R25, K36745R25, K37179R25, K37568A25, K39623A25, K41271A25, K36344R30, K36444R30, K36745R30, K37179R30, K37568A30, K39247A30, K39247B30, K39274A30, K39274B30, K39274C30, K39623B30, K39926A30, K36344R60;
K36307R25, K36957R25, K37551A25, K41982A25, K42847A25, K38491A25, K38758B25, K39629A25, K40123C25, K36307R30, K36957R30, K37295R30, K37551A30, K38162A30, K38162B30, K41982B30, K38491B30, K38758A30, K38758C30, K38758D30, K39629B30, K40123A30, K40123B30, K36307R60;
K40913R25, K41481R25, K42060R25, K42572R25, K42959R25, K40913R30, K41481R30, K42060R30, K42061R30, K42572R30, K42959R30;
K35731B25, K42045A25, K38703A25, K39420B30, K40491A25, K41042A25, K35731A30, K35731E30, K35731F30, K35731G30, K38703B30, K39420A30, K40007A30, K40007B30, K40491B30, K41042B30, K35731C60, K35731D90;
K41294R25, K37642R25, K41723R30, K43115R30, K37642R30;
K37651R25, K37651R30;
K43134R25, K43134R30;
K42848R25, K43348R25, K42848R30, K43348R30;
K38490A25, K42776R25, K43141R25, K40097B25, K38490A30, K42776R30, K43141R30, K40097A30;
K36253A25, K36723B25, K39505C25, K36253A30, K41609A30, K36723A30, K39505A30, K36253A60;
K37766C25, K38442A30, K38442D25, K39290A25, K42147A25, K42432A25, K40165A25, K40975B25, K37097A30, K37766A30, K37766B30, K38442B30, K38442C30, K39290B30, K40487A30, K40487B30, K42147B30, K40165B30, K40975A30;
K35855A25, K37805A25, K42143A25, K40406A25, K40974A25, K35667B30, K35855C30, K35855D30, K36693A30, K37080A30, K38755A30, K42143B30, K39618A30, K39739A30, K40406B30, K40406C30, K40974B30, K35667A60, K35855B60;
K35648A25, K35656A25, K36377A25, K36713C25, K38545B25, K40379B25, K35758A30, K36377B30, K36377C30, K36713A30, K36713B30, K36713D30, K37081A30, K37396A30, K38545A30, K38545C30, K38693A30, K38693B30, K40379A30;
K39812A25, K40565A25, K39812A30, K41575A30, K42117A30;
K39700A25, K43146A25, K39700A30, K40566A30;
K42384A25, K39814A25, K39814A30, K40492A30, K40492B30;
K34944C25, K35364A25, K38464A25, K41607A25, K40158A25, K38464B30, K41607B30, K39696A30, K39696B30, K40158B30, K40489A30, K34944A60, K34944B60;
K41311R25, K41920R25, K42305R25, K42811R25, K41311R30, K41920R30, K42305R30, K42811R30;
K40651R25, K41295R25, K41757R25, K42574R25, K42958R25, K43406R25, K40651R30, K41295R30, K41757R30, K42574R30, K42958R30, K43406R30;
K40647R25, K41099R25, K41891R25, K42202R25, K42802R25, K43350R25, K40647R30, K41099R30, K41891R30, K41892R30, K42202R30, K42802R30, K43350R30;
K36663R30, K37343R30, K37716A30, K37064R30, K41602A30, K38054A30, K38054B30, K38632A30, K38756A30, K38756B30, K39438A30, K39438B30, K41050A30;
K42690R30, K41475R30, K42078R30, K42309R30, K40910R30;
K36663R25;
K42778R25, K43082R25, K42778R30, K43082R30;
K42936R25, K42936R30;
K42935R25, K42935R30;
K36219B25, K37050A25, K38596B25, K40411A25, K36219A30, K37400A30, K37400B30, K37767A30, K38596A30, K38596C30, K38596D30, K39462A30, K40919A25, K40919B30, K41140A30;
K37768A25, K38492A25, K42289A25, K40412B25, K36410A30, K36410B30, K37014A30, K37399A30, K37399B30, K38492B30, K38493A30, K39463A30, K40412A30, K40972A30;
K38435A25, K42162A25, k39891A25, K40222B25, K36407A30, K36407B30, K37051A30, K37821A30, K38702A30, K39289A30, K39891B30, K40222A30, K41054A30;
K42496R30;
K36799A25, K41950A25, K42581A25, K39921A25, K36799B30, K36800B30, K40298A30, K36348A60, K36800A60, K36800C60, K41950B60, K39921B60, K39921C60, K39921D60;
K41421A25, K39524A25, K39923B25, K40490A25, K41420B30, K41421B30, K39524B30, K3971930, K39923A30, K39923C30, K40324A30, K40490B30, K40762A30, K40762B30;
K41600A25, K43195A25, K39002A25, K40761A25, K40761C25, K41599A30, K41600B30, K38559A30, K38559B30, K39002B30, K40285A30, K40285B30, K40761B30, K40761D30;
K41600A25, K43195A25, K39002A25, K40761A25, K40761C25, K41599A30, K41600B30, K38559A30, K38559B30, K39002B30, K40285A30, K40285B30, K40761B30, K40761D30;
K42137A25, K39079A25, K39079C25, K40888A25, K37297A30, K37737A30, K38992A30, K39079B30, K39079D30, K39171A30, K40413A30, K40413B30, K40888B30;
K42265A25;
K37283A25, K37745A25, K37745B25, K38751A25, K39863A25, K39863B25, K41254B25, K37283A30, K37745C30, K38751B30, K38751C30, K39332A30, K39863C30, K41254A30;
K37282A25, K38541A25, K38541B25, K42417A25, K40189A25, K40189B25, K37282A30, K37689A30, K38541C30, K42417B30, K38918A30, K38918B30, K39329A30, K40981A30;
K42527A30;
K36812A25, K42239A25;
K41409R25, K41972R25, K42286R25, K42934R25, K41409R30, K41972R30, K42286R30, K42934R30;
K42915A25, K36517A30, K37770B30, K38121A30, K38121B30, K37770A60;
K36129A25, K36129B25, K36226B25, K36226C25, K36226E25, K36809C25, K38082B25, K38883A25, K42564A25, K35538A30, K35852A30, K36226D30, K36809A30, K36809B30, K38082A30, K38082C30, K38554A30, K42564B25, K39709A30, K39709B30, K34172A60, K36226A60;
K43057R25, K43145R25, K43057R30, K43145R30
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo, OH, by letter dated July 28, 2006. Firm initiated recall is ongoing.
REASON
Mispacked; possibility of a product package mix-up.
VOLUME OF PRODUCT IN COMMERCE
440,148 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Docusate Sodium Softgels, 100 mg, packed in bulk cartons containing 18,000 softgel capsules for further manufacturing, processing or repackaging. Banner™, Product code: LPE-68, Recall # D-389-7
CODE
Lot number: 26040562
RECALLING FIRM/MANUFACTURER
Banner Pharmacaps, Inc., High Point, NC, by telephone on September 15, 2006. Firm initiated recall is ongoing.
REASON
Presence of foreign capsule; Vitamin E, 400 I.U. capsules mixed with the product.
VOLUME OF PRODUCT IN COMMERCE
4,502,500 capsules
DISTRIBUTION
MI
______________________________
PRODUCT
Product Description: Stool Softener, (docusate sodium) Stool Softener Laxative Softgels, 100 mg each, packaged in bottles of 60 and 100, ALSO packaged under the following brand names: HyVee, NDC 42507-486-72; Target, NDC 11673-486-78; TopCare, NDC 36800-486-78 and 36800-486-72, Recall # D-393-7
CODE
Lots 6GE0038 and 6GE0068; exp. 03/2008.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perrigo Company, Allegan, MI, by letter dated September 25, 2006.
Manufacturer: Banner Pharmacaps Inc, High Point NC. Firm initiated recall is ongoing.
REASON
Presence of foreign capsules; Vitamin E, 400 I.U. capsules mixed with the product.
VOLUME OF PRODUCT IN COMMERCE
41,544 bottles
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0019-7
CODE
Unit: 53GX25624
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on April 13, 2005 and by letter dated April 14, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom documentation of a hematocrit test during the donor screening process was discrepant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0080-7
CODE
Unit: 006KG42641
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on June 21, 2005. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable shipping temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
______________________________
PRODUCT
Source Plasma, Recall # B-0127-7
CODE
Units: 0050254455, 0050253266, 0050252987, 0050252656, 0050252404, 0050252190, 0050251871, 0050251526, 0050251242, 0050250909, 0050250559, 0050250334, 0050247456, 0050247046, 0050246278, 0050245486, 0050242019, 0050236800
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Beloit, WI, by facsimile transmission dated March 15, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor with participated in high risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
UK
______________________________
PRODUCT
Source Plasma, Recall # B-0160-7
CODE
Units: 68664169, 68650124, 68648299, 68643454
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0161-7
CODE
Units: 68621933, 68620080
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 21, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0162-7
CODE
Units: 68668877, 68664350, 68633875
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0163-7
CODE
Units: 68686871, 68683238, 68678425, 68674861, 68671037, 68665203, 68660994, 68658397, 68654276, 68650179, 68645830, 68639686, 68636920, 68621971, 68624392
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 21, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0164-7
CODE
Units: 68684402, 68681876, 68679446, 68674588, 68671976, 68667474, 68665135
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0165-7
CODE
Unit: 68676056
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0166-7
CODE
Units: 68648121, 68645663, 68641207, 68638559, 68625207, 68621063, 68618322, 68613846, 68611279
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0167-7
CODE
Units: 02HWVA6493, 02HWVA7104, 02HWVA7567, 02HWVA8654, 02HWVA8902, 02HWVA9129, 02HWVA9494, 02HWVA9745
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services, L.P., Deerfield, IL, by facsimile on April 5, 2004.
Manufacturing Firm: BioLife Plasma Services, L.P., Huntington, WV. Firm initiated Recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
NC
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0175-7;
b) Recovered Plasma, Recall # B-0176-7
CODE
a) and b) Unit: 29KJ25174
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Norfolk, VA, by telephone and by letter on September 9 and 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and CA
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0178-7
CODE
Unit: 71X134609
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham, AL, by facsimile on March 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in appropriately and did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0179-7
CODE
Unit: 71X275904
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham, AL, by facsimile on August 16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured inappropriately and did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0180-7
CODE
Unit: 71X275781
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham, AL, by facsimile on August 16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured inappropriately and did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0181-7
CODE
Unit: FJ13120
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on June 17, 2006 and by letters dated July 24, 2006. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0182-7;
b) Fresh Frozen Plasma, Recall # B-0183-7
CODE
a) and b) Unit: 040FG51387
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL, by telephone on August 17, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0187-7
CODE
Units: 6921729 and 6925030
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and NJ
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0188-7
CODE
Unit: 6901826
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 9, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0189-7;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0190-7
CODE
a) Units: 6593702 and 6590860;
b) Units: 9020192 and 6596489
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 23, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CO, TN and KS
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0191-7
CODE
Unit: 9012677
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 25, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0192-7
CODE
Unit: 6593096
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 3, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________
PRODUCT
Red Blood Cells, Recall # B-0193-7
CODE
Unit: 6898868
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 9, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0194-7;
b) Platelets, Recall # B-0195-7
CODE
a) and b) Units: 5711363
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on January 27, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0201-7
CODE
Units: 7X428913, 71X459152, and 71X42582X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by letters dated May 9, 10, and 18, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0202-7
CODE
Units: 177340217 (split)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone on July 19, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0203-7;
b) Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0204-7;
c) Recovered Plasma, Recall # B-0205-7
CODE
a) and c) Unit: 177338315;
b) Units: 172007146 and 172007416
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by electronic mail and letter on May 16 and June 9, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in an area that was high risk for group O HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, and Switzerland
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0206-7
CODE
Unit: 177347693
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by letter dated November 18, 2004. Firm initiated recall is complete.
REASON
Blood product, which may have been shipped under unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0207-7;
b) Platelets, Recall # B-0208-7;
c) Fresh Frozen Plasma, Recall # B-0209-7
CODE
a), b), and c) Unit: 16365-5991
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on March 29, 2004.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MS
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0210-7
CODE
Unit: 172036155
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone on June 2, 2004. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
______________________________
PRODUCT
Human Cornea for Transplantation, Recall # B-0211-7
CODE
Tissue: 06-0137-200
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville, TN, by telephone on July 28, 2006. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBcore) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
NC
______________________________
PRODUCT
Human Cornea for Transplantation, Recall # B-0213-7
CODE
Tissue: 06-0797-200
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO, by telephone on July 25, 2006, and by letter dated August 22, 2006. Firm initiated recall is complete.
REASON
Human Cornea, mislabeled and distributed prior to completion of donor eligibility determination.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
IL
______________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-0228-7
CODE
Unit: 16459-1747
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MS, by telephone on August 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
______________________________
PRODUCT
Source Plasma, Recall # B-0230-7
CODE
Unit: 68681142, 68677299, 68673321, 68670177, 68666446, 68663155, 68658694
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0231-7
CODE
Units: 68683818, 68682453, 68677725, 68673666, 68670320, 68667153, 68663476, 68660321, 68646646, 68642457, 68639785, 68634827, 68633011
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CA
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0232-7;
b) Platelets, Leukocytes Reduced, Recall # B-0233-7
CODE
a) and b) Unit: 042W45670
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on March 27, 2006 and by letter dated March 28, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
______________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-235-7;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-236-7
CODE
a) Units 038P98790 (split), 038P98783 (split), 038P98780 (split), 038P98785 (split), and 038P98782 (split);
b) Units 016KK13499 and 050KP02608 (split)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on October 26 and 27, 2005 and by letters dated October 27 and 28, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped under unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
OH
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0237-7
CODE
Unit: 006KC70764 (split)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone and by letter on October 28, and December 9, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped under unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
_____________________________
PRODUCT
a) Red Blood Cells, Recall # B-0238-7;
b) Fresh Frozen Plasma, Recall # B-0239-7
CODE
a) and b) Unit: 7754703
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by telephone on December 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0245-7
CODE
Unit: H79149
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter dated December 28, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0250-7;
b) Recovered Plasma, Recall # B-0251-7
CODE
a) and b) Unit: 20728-0349
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated April 6, 2005 or by electronic notification on May 18, 2005.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA and Switzerland
______________________________
PRODUCT
Source Plasma, Recall # B-0252-7
CODE
Units: 68685676, 68679545, 68675752, 68672041
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
______________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0258-7;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0259-7;
c) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0260-7
CODE
a) Unit: 9007545;
b) Unit: 9002605 (parts 1 & 2);
c) Unit: 9002605 (part 3)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 29, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CO
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0261-7
CODE
Units: 6922389 and 6920225
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 16, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO
______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0028-7
CODE
Units: 17FS32546 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by facsimile on July 2, 2004. Firm initiated recall is complete.
REASON
Blood products, for which documentation of an abnormal alarm during apheresis collection was discrepant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD and MA
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0159-7
CODE
Unit: 16458-9990
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated December 1, 2004.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, which contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0168-7
CODE
Unit: 16380-9558
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 3, 2005.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was taken using unvalidated equipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
______________________________
PRODUCT
Red Blood Cells, Recall # B-0169-7
CODE
Unit: 3968118
RECALLING FIRM/MANUFACTURER
Department of the Army, Armed Services Blood Bank Center, Landstuhl, Germany, by electronic mail on August 17, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0177-7
CODE
Unit: 20GZ16279
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID, by letter dated July 12, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0184-7
CODE
Unit: 5578225 (split)
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on August 4, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
IL
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0196-7;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0197-7
CODE
a) Unit: 9153541;
b) Unit: 9154220
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured per standard operating procedure, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO, and TN
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0198-7
CODE
Units: 9016846 and 9029364
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured per standard operating procedure, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and NB
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0200-7
CODE
Unit: 9031995 (split)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 23, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and FL
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0217-7;
b) Plasma, Recall # B-0218-7
CODE
a) and b) Unit: 29KH41430
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlanta Region, Norfolk, VA, by telephone on May 23, 2005, and by letters dated May 26, 2005, and July 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and VA
______________________________
PRODUCT
Red Blood Cells, Apheresis, Leukocytes Reduced, Recall # B-0229-7
CODE
Unit: 164584975
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Meridian, MA, by telephone on May 7, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0234-7
CODE
Units: 050LW28693 and 018GP17967
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on October 26 and 27, 2005 and by letters dated October 27 and 28, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped under unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0243-7
CODE
Unit: 16460-9254
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 30, 2004.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, manufactured from a Whole Blood unit, which contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
Class II Device Recall Extended.
Z-1502-06 was reported in the September 20, 2006 Enforcement Report. The recall has been extended to include 310 more devices.
______________________
PRODUCT
LIFEPAK 20 external defibrillator/monitor, Recall # Z-1502-06
CODE
LP 20 domestic serial numbers 34107307, 33911492, 33946302, 33894355, 33933894, 33951494, 33980272, 33986554, 33924702, 33881437, 33905482, 33894423, 33951266, 33905466, 33955767, 33971830, 34022189, 34071195, 34107256, 33900980, 33971829, 33980275, 33980280, 33980281, 33980287, 34017814, 34107419, 34071134, 33986933, 33947927, 34071165, 33967385, 34066585, 34071189, 34011819, 34011822, 33894426, 33894572, 33900981, 33936889, 34054495, 34060183, 33938363, 33959538, 33981789, 33981792, 33981793, 33981794, 33981795, 33981796, 33981797, 33981799, 33981805, 34071237, 34011821, 33894425, 33922299, 33938921, 33938924, 33959550, 33930122, 33933904, 34107178, 33955760, 33897337, 33955747, 33894255, 33951295, 33951456, 33976455, 33951447, 33894406, 33951275, 33933878, 33946268, 33946277, 33976406, 33976407, 33976408, 33976410, 33976411, 33976412, 33976413, 33976414, 33976415, 33976416, 33976417, 33976418, 33976419, 33976420, 33976424, 33976426, 33976427, 33976428, 33976429, 33976430, 33976431, 33979469, 33979470, 33979471, 33979472, 33979473, 33979474, 33905581, 33905585, 33905590, 33905609, 33905621, 33905622, 33911446, 33911449, 33911450, 33911470, 33911477, 33911528, 33911571, 33897320, 33897322, 33897329, 33897342, 33905514, 33905518, 33911627, 33955832, 33951484, 33951605, 33955759, 33955765, 34017742, 34107418, 33951059, 33951467, 34017810, 34022168, 34022175, 34022176, 33951473, 33951487, 34017813, 33955761, 33894580, 33992539, 33905444, 33971948, 33950588, 33951128, 33951273, 33951287, 33951434, 33951551, 33915884, 33915964, 33922357, 34066561, 33911587, 33971953, 33986931, 33997554, 33955806, 33955833, 34003587, 34003615, 34011698, 34011712, 34022213, 33947935, 33967345, 33967356, 33967367, 33967382, 33967402, 33967413, 33971817, 33971825, 33971832, 33971853, 33971860, 33971898, 33980313, 33981782, 33981787, 33986322, 30568540, 33951292, 33951293, 33951403, 33951409, 33951462, 33951468, 33951497, 33951518, 33951535, 33951552, 33951553, 33951560, 33951569, 33951576, 33951580, 33951582, 33951583, 33951585, 33951586, 33951588, 33951589, 33951592, 33951593, 33951595, 33951597, 33951598, 33951599, 33951600, 33951601, 33951604, 33955748, 33955751, 33955752, 33959570, 33992551, 33992569, 34022195, 34052650, 34052661, 34052662, 34052673, 34052685, 34052686, 34054508, 34060208, 34060827, 34060849, 34063588, 34063590, 34063596, 34063600, 34063602, 34063603, 34063604, 34063605, 34063606, 34063607, 34063608, 34063615, 34063619, 34066562, 34066573, 34066574, 34066576, 34066581, 34066584, 34066587, 34107052, 34107058, 34107059, 34107118, 34107165, 34107170, 34107171, 32601734, 33894320, 33946296, 34011706, 33997567, 33901753, 33901761, 33901762, 33901770, 33901771, 33901773, 33901777, 33901782, 33901787, 33904876, 33904910, 33904913, 33904914, 33904917, 33904921, 33904922, 33904923, 33904926, 33904928, 33904929, 33904931, 33904932, 33904933, 33904936, 33904937, 33904938, 33905427, 33905430, 33905432, 33905434, 33905440, 33905441, 33905443, 33905451, 33905470, 33905473, 33905474, 33905488, 33967403, 33981780, 33911601, 33915910, 33915916, 33915917, 33915961, 33959578, 33894289, 33897319, 33905507, 33905516, 33905520, 33905521, 33911611, 33911614, 33911624, 33911631, 33911632, 33911634, 33911635, 33917440, 33917443, 33917444, 33917447, 33917448, 33917452, 33917453, 33917454, 33917455, 33917456, 33917457, 33917461, 33917463, 33917464, 33917465, 33917466, 33917467, 33917468, 33917470, 33921045, 33921046, 33921047, 33921049, 33921050, 33921052, 33921053, 33921055, 33922294, 33959606, 33951603, 33955750, 33955762, 33955771, 34107379, 34071180, 34071197, 34107378, 34107380, 34107411, 34107426,34107438, 33986324, 33986555, 33979488, 33980264, 33981778, 33986878, 33986897, 33904924, 33905459, 33905495, 33905496, 33905497, 33905587, 33911468, 33933906, 33901735, 31491390, 33894413, 33938926, 33951405, 33951426, 33951596, 33955802, 33955803, 33955827, 33955829, 33955831, 33955839, 33924675, 33924679, 33947909, 33986550, 33986566, 33986915, 33986917, 33986920, 33986921, 33986922, 33986923, 33986924, 33986925, 33990262, 33990270, 34015700, 33997552, 33901737, 33904878, 33905438, 33986873, 33986877, 34071213, 33924704, 33950587, 33951283, 33951298, 34107265, 34017808, 33976463, 33980266, 33980278, 33980279, 33980285, 33980290, 33980291, 33980294, 33980301, 33980304, 33911597, 33911602, 33911603, 33915887, 33915888, 33915889, 33915890, 33915892, 33915893, 33915894, 33915895, 33915897, 33915898, 33915899, 33915908, 33915911, 33915912, 33915914, 33915919, 33915922, 33915925, 33915928, 33915929, 33915930, 33915931, 33936874, 33936877, 33947249, 33947264, 33947931, 33976446, 33976447, 33976456, 33976468, 33976470, 33976471, 33976477, 33976478, 33976479, 34011825, 34017783, 33971838, 33971901, 33971905, 33971910, 33980268, 33980300, 33986330, 33986338, 33986342, 33986344, 33986345, 33986348, 33986349, 33986351, 33986543, 33986561, 33986562, 33986563, 33986564, 33986565, 34017806, 33897344, 33897350, 34063598, 34063616, 33990265, 34015699, 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34107415, 34107420 Military serial numbers: 33894425, 33894255, 33997567, 33959578, 33894287, 33938356, 33938357, 33938359, 33938928, 33951441, 33951459, 33955756, 33955770, 33955778, 33955779, 33955780, 33955781, 33955782, 33955784, 33955785, 33955787, 33955788, 33955789, 33955790, 33955791, 33955793, 33955795, 33955796, 33955798, 33955800, 33955801, 33955805, 33955830, 33955846, 33955847, 33955853, 33959560, 33959561, 33959562, 33959568, 33959572, 33959573, 33959574, 33959602, 33959603, 33959609, 33981808, 33981809, 33986865, 33992540, 33992542, 33992545, 33992547, 33992549, 33992550, 33992552, 33992553, 33992554, 33992555, 33992556, 33992557, 33992558, 33992559, 33992560, 33992561, 33992562, 33992563, 33992564, 33992565, 33992566, 33992567, 33992568, 33992571, 33992572, 34022190, 34022191, 34022193, 34022194, 34022196, 34022197, 34022199, 34022200, 34052635, 34052637, 34052638, 34052641, 34052642, 34052643, 34052645, 34052646, 34052647, 34052652, 34052656, 34052657, 34052665, 34052671, 34052672, 34052675, 34052676, 34052677, 34052679, 34052683, 34052684, 34052692, 34052695, 34054492, 34054494, 34054500, 34054510, 34054512, 34054532, 34054534, 34060185, 34060186, 34060187, 34060188, 34060189, 34060190, 34060193, 34060194, 34060195, 34060196, 34060200, 34060201, 34060205, 34060209, 34060210, 34060214, 34060215, 34060216, 34060819, 34060820, 34060824 International serial numbers: 33947246, 33947247, 33892605, 33893092, 33894357, 33894359, 33894360, 33894366, 33894369, 33894370, 33894373, 33894378, 33894380, 33933865, 33933874, 33933882, 33933948, 33946270, 33946278, 34003572, 34003579, 34003584, 34003597, 33894325, 33900857, 33930119, 33933884, 33933887, 33933889, 33933892, 33933893, 33933895, 33933898, 33933912, 33933913, 33971956, 34071200, 34107253, 34107377, 34107381, 33894298, 33894427, 33950568, 33950569, 33959558, 33959599, 34052644, 34052668, 34052670, 34060818, 34060845, 34060846, 34060848, 34063584, 34063586, 34063591, 34063629, 34063634, 34066565, 34066569, 34066580, 34066586, 34107066, 34107083, 34107096, 34107109, 34107115, 34107120, 34107169, 33946287, 33986792, 33986799, 33990253, 33990273, 34011810, 34011815, 34011816, 34011826, 34015710, 34022166, 34022171, 34022179, 34022180, 34066504, 34066516, 34066517, 34066518, 34066520, 34066521, 34066522, 34066523, 34066524, 34066525, 34066528, 34066529, 34066530, 34066531, 34066532, 34071145, 34071160, 34071161, 34071163, 34071164, 34071166, 34071169, 34071170, 34071172, 34071174, 34071179, 34071182, 34071183, 34071184, 34071194, 34071196, 34071199, 34071201, 34071215, 34107258, 34107320, 34107386, 34107400, 34107403, 34107409, 34107413, 34107414, 34107416, 34107417, 34107424, 34107433, 34060211, 34060831, 34060838, 34060839, 34063577, 33892622, 33893090, 33894358, 33894379, 33894568, 33894579, 33894581, 33894588, 33971961, 33971962, 33892602, 33893076, 33893079, 33893085, 33946272, 33947877, 33905605, 33905610, 33905613, 33911432, 33915932, 33915934, 33915942, 33915948, 33922354, 33971943, 33971947, 33971955, 33976434, 33976436, 33976437, 33976440, 33976443, 33981765, 33986907, 34017812, 34071188, 33981806, 33986830, 33894245, 33894246, 33894247, 33894248, 33894249, 33894254, 33894256, 33894292, 33894293, 33894295, 33894296, 33894297, 33894299, 33894300, 33894301, 33894302, 33894303, 33894304, 33894305, 33894312, 33894313, 33894314, 33894393, 33894395, 33894396, 33894397, 33894398, 33894399, 33894400, 33894402, 33894403, 33894405, 33894407, 33894408, 33894575, 33894576, 33894595, 33950445, 33951111, 33959537, 33981804, 33981807, 33981810, 33981811, 33986816, 33986817, 33986818, 33986819, 33986820, 33986821, 33986822, 33986824, 33986828, 33986831, 33986834, 34063626, 34063641, 34066564, 33893102, 34011831, 34017800, 34071132, 33894391, 34107239, 34107270, 34107330, 34107339, 34107391, 34107392, 34107398, 34107399, 33986928, 33990259, 33881434, 33881439, 33881441, 33892607, 33892617, 33893073, 33893081, 33893094, 33894550, 33898433, 33898443, 33898444, 33932691, 33932735, 33933862, 33933880, 33933933, 33933934, 33933935, 33933936, 33933940, 33933943, 33946284, 33946290, 33946291, 33946292, 33947871, 33947873, 33881436, 33893100, 33893103, 33947878, 33947887, 34003621, 33892589, 33892591, 33892592, 33892596, 33892597, 33892598, 33892600, 33892604, 33892608, 33892610, 33892615, 33892619, 33892621, 33893077, 33893080, 33893084, 33893087, 33893089, 33893091, 33893095, 33892606, 33892609, 33893088, 33894372, 34003564, 34003588, 34003590, 34003605, 34003611, 34003619, 34003628, 34011697, 34011704, 34011707, 33881438, 33929478, 33932732, 33933871, 33947881, 33947889, 33979529, 33979559, 34003594, 33905606, 33905624, 33911517, 33922360, 33922361, 33922366, 33930126, 33936882, 33936890, 33936901, 33936905, 33936908, 33946309, 34066514, 33911514, 33911519, 33930111, 33947932, 33971915, 33971930, 33971952, 33971960, 33976435, 33976467, 33980269, 33980292, 33990251, 33990255, 33990257, 33990260, 33990261, 33990264, 33990269, 34017740, 34017797, 33894319, 33894322, 33976473, 33971929, 34066515, 34071147, 34071148, 34071154, 34071156, 33911440, 33915946, 33922365, 33930104, 33976484, 33980284, 34066502, 33976462, 33892612, 33892613, 33892614, 33892616, 33892618, 33893074, 33893082, 33893086, 33893093, 33893096, 33893099, 33893107, 33894363, 33894368, 33894549, 33933875, 33933879, 33933951, 33933957, 33946275, 33946279, 33946294, 33946295, 33947869, 33947870, 33947872, 33947874, 33947879, 33947882, 33947885, 33947888, 33947892, 33976405, 33979493, 33979510, 33986796, 33986798, 33986801, 33986802, 33986803, 33986804, 33986805, 33986806, 33986810, 33986812, 33986813, 34003577, 34003591, 34003606, 34003608, 34003613, 34003620, 34003623, 34003624, 34003629, 34011699, 34011700, 34011701, 33915959, 33922373, 33922374, 33922379, 33922380, 33922381, 33924667, 33924668, 33924670, 33924677, 33933899, 33933908, 33936858, 33936900, 33936913, 33971912, 33971931, 33971951, 33971957, 33971958, 33976438, 33976439, 33976442, 33976444, 33976449, 33976466, 33976469, 33980302, 33981785, 33986347, 33986875, 33986914, 33986918, 33990263, 34015701, 34015716, 34015732, 34015743, 34017772, 34017802, 34017811, 34022165, 34022170, 34066480, 34066482, 34066484, 34066485, 34066486, 34066488, 34066489, 34066490, 34066494, 34066495, 34066497, 34066499, 34066500, 34066501, 34066503, 34071162, 34071167, 34071177, 33894422, 33897347, 33950575, 33950579, 33951103, 33951401, 33894250, 33894570, 33897330, 33897334, 33897345, 33897349, 33897351, 33905504, 33951122, 33951127, 33951587, 33951591, 33955843, 33959557, 33959604, 33981801, 34052678,34052680, 34054490, 34063618, 33897348, 33955850, 33959543, 33959551, 33992548, 34063613, 33894251, 33894294, 33897338, 33897339, 33951271, 33951402, 34107069, 33922297, 33950447, 33950452, 33950453, 33950454, 33950455, 33950456, 33950457, 33950570, 33950572, 33950573, 33950576, 33950578, 33955783, 33959541, 33959548, 34107110, 33884883, 33955777, 33986326, 33893098, 33893104, 33893105, 33893106, 33894356, 33894361, 33894362, 33894365, 33894371, 33894374, 33894376, 33894377, 33894554, 33898432, 33898435, 33898436, 33898446, 33932681, 33932689, 33932741, 33932744, 33933859, 33933861, 33933863, 33933868, 33933869, 33933876, 33933877, 33933937, 33933942, 33933945, 33946269, 33946282, 33946289, 33979537, 33979555, 33979558, 33979563, 33986793, 33986795, 33986797, 33986800, 33986807, 33986808, 33986809, 33986811, 33986814, 33986815, 33991479, 33991480, 33991482, 33991485, 33991486, 33991487, 33991492, 33991493, 33991495, 33991496, 33991497, 33991498, 34003562, 34003563, 34003566, 34003575, 34003580, 34003586, 34003595, 34003602, 34003603, 34003607, 34003609, 34003612, 34003626, 34003630, 34011714, 33904919, 33905433, 33905442, 33905446, 33905447, 33905449, 33905463, 33905467, 33905468, 33905577, 33905591, 33905618, 33905619, 33911511, 33915883, 33915886, 33930109, 33930110, 33930114, 33930116, 33933929, 33936911, 34017745, 34017791, 33819592, 33881450, 33893078, 33893083, 33893101, 33894367, 33894375, 33894381, 33894383, 33894384, 33894385, 33894386, 33894388, 33894389, 33894390, 33932679, 33933858, 33933870, 33933872, 33933944, 33933886, 33936902, 33947930, 34003598, 34022201, 33976480, 33976481, 33976482, 33976483, 33917460, 33921054, 33921056, 33951594, 34060847, 33894291, 33894571, 33921048, 33950446, 33950449, 33950574, 33950583, 33955834, 34060203, 34060207, 34060212, 34060817, 34060821, 34060825, 34060828, 34060832, 34060836, 34060852, 34060853, 34063566, 34063567, 34063568, 34063571, 34063573, 34063574, 34063575, 34063579, 34063582, 33955808, 33955810, 33955811, 33894596, 33898431, 33898441, 33898442, 33900686, 33894364, 33894553, 33898429, 33898449, 33929477, 33929479, 33933867, 33946286, 33947876, 33976425, 33979505, 33991484, 33991489, 34011703, 33929476, 33933939, 34003592, 34003593, 33894551, 33932678, 34011696, 33932722, 33933864, 33933866, 33933938, 33933941, 33933949, 33933950, 33933952, 33933953, 33933954, 33922359, 33894333, 33915957, 33915960, 33922364, 34011834, 33894324, 33915927, 33922362, 33922370, 33947911, 33947914, 33997578, 34011813, 34015723, 34066506, 34066509, 34066511, 33915933, 33922363, 33922367, 33922368, 33922375, 33924666, 34107387, 33915943, 33924700, 33930108, 33930115, 33930120, 33930123, 33933883, 33933885, 33933891, 33933902, 30523635, 33890401, 33892594, 33892599, 33892601, 33892603, 33933860, 33933873, 33933946, 33933947, 33933955, 33933956, 33946267, 33946273, 33946276, 33946280, 33946283, 33947880, 33947891, 33979545, 33986794, 33991477, 33991478, 33991483, 33991494, 33991499, 34003565, 34003589, 34011705, 34011708, 34022206, 34022210, 34022211, 34022212, 33894317, 33924662, 33924671, 33924673, 33924674, 33924676, 33924680, 33930099, 33930100, 33980270, 33980299, 33980305, 33986926, 33986927, 33986930, 33986932, 33990256, 33990258, 33990266, 33997553, 33997574, 33997575, 34011829, 34066496, 34066508, 34066513, 34066519, 34071146, 34071149, 34071150, 34071151, 34071157, 34003578, 33922376, 33922378, 33922382, 33924665, 33924669, 33924672, 33924678, 33924683, 33924691, 33930141, 33933903, 33814107, 33892588, 33892590, 33892595, 33892611, 33892620, 33893072, 33893075, 33933897, 33947895, 33947906, 33947918, 33947926, 33947928, 33922295, 33951064, 33894253, 33959545, 33938358, 33950582, 33950585, 33951084, 33951117, 33951119, 33951120, 33951123, 33951125, 33951126, 33951132, 34052681, 33938361, 33955823, 33959544, 33959553, 33959566, 33959607, 33959608, 33981790, 34054517, 33938925, 33950586, 33951074, 33951115, 33951116, 34022198, 33959600, 34054528, 34054531, 33894387, 34003571, 34003574, 34003576, 34003596, 34003599, 34011715, 34011717, 34011722, 33905620, 34015714, 34017733, 34017798, 34017805, 34071191, 34060841, 34066568, 33915902, 33820870, 33829090, 33829105, 33884866, 33884867, 33884871, 33884872, 33884879, 33884912, 33884898, 33819680, 33829407, 33826068, 33884924, 33951423, 33790153, 33814964, 33884875, 33884882, 33884911, 33884958, 33613420, 33818739, 33826069, 33826084, 33884945, 33884962, 33885006, 33826097, 33884926, 33889433, 33808150, 33884980, 33889427, 33884970, 33826088, 33884923, 33491192, 33884974, 33818758, 33819636, 33829400, 33884953, 33889416, 33826087, 33889430, 33884876, 33884950, 33829119, 33884959, 33884925, 33790157, 33889429, 33819651, 33901121, 33901728, 33578551, 33613419, 33829091, 33829095, 33884885, 33884889, 33890408, 33889424, 33826079, 33881371, 33884922, 33889471, 33884920, 33884927, 33884935, 33889422, 33889504, 33890404, 33881410, 33881418, 33889481, 33890395, 33890396, 33890402, 33890406, 33881399, 33881411, 33819657, 33829394, 33829408, 33884918, 33884932, 33884954, 33884986, 33885001, 33889418, 33889420, 33889431, 33884951, 33884955, 33884998, 33889472, 33884989, 33884994, 33889421, 33889426, 33884949, 33884956, 33881421, 33889497, 33890389, 33890390, 33890397, 33890398, 33890403, 33890407, 33890409, 33890417, 33594407, 33811122, 33826051, 33884919, 33884921, 33884933, 33884939, 33884941, 33884943, 33884947, 33889414, 33889415, 33889417, 33889432, 33889475, 33790158, 33884900, 33884916, 33884891, 33884906, 33884907, 33884914, 33884915, 33829094, 33829101, 33884869, 33884877, 33884880, 33884893, 33884895, 33884905, 33884913, 33829108, 33826072, 33889425, 33889434, 33881406, 33818742, 33818787, 33818791, 33819608, 33819635, 33819643, 33819655, 33819667, 33826060, 33884884, 33884886, 33884894, 33884909, 33823326, 33881386, 33881405, 33881432, 33881451, 33881453, 33889495, 33889503, 33890405, 33890411, 33881423, 33881426, 33881446, 33881448, 33818745, 33819641, 33819679, 33884936, 33884938, 33884944, 33819609, 33829398, 33819656, 33826058, 33884934, 33829395, 33829409, 33818746, 33649902, 33794792, 33814152, 33814163, 33814234, 33819591, 33823333, 33881395, 33881398, 33881400, 33881407, 33881417, 33881420, 33881424, 33881425, 33881427, 33881428, 33881429, 33881430, 33881431, 33881433, 33881435, 33881440, 33881442, 33881443, 33881447, 33881449, 33881452, 33881454, 33881455, 33889477, 33889479, 33889480, 33889484, 33889486, 33889487, 33889488, 33889489, 33889490, 33889491, 33889492, 33889493, 33889494, 33889496, 33889500, 33890399, 33890412, 33890413, 33890414, 33890415, 33890416, 33890418, 33427202, 33488173, 33805092, 33808075, 33818756, 33818757, 33818766, 33818781, 33818782, 33818785, 33819638, 33819645, 33819648, 33819674, 33826083, 33826093, 33826094, 33884931, 33884942, 33884946, 33884948, 33889428, 33884917, 33820892, 33884881, 33884892, 33804989, 33884874, 33884878, 33884870, 33884896, 33814974, 33829114, 33829120, 33884887, 33884890, 33884897, 33884899, 33814227, 33814155, 33881368, 33881385, 33881388, 33881397, 33881419, 33889483, 33889498, 33889499, 33889501, 33889502, 33890400, 33890410, 33890420, 33890421, 33890422, 33890423, 33890424, 33884888, 33884901, 33884902, 33884903, 33884904, 33884908, 33884910, 33826076, 33884928
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on August 30, 2006. On 10/19/06 the firm mailed an identical letter dated October 2006 to customers for units that were later identified as being subject to the recall. Firm initiated recall is ongoing.
REASON
Devices with v38 system software do not display a "LOW BATTERY: CONNECT TO AC POWER" message when the monitor is on backup (DC) battery power and may shut down without warning.
VOLUME OF PRODUCT IN COMMERCE
3141 devices worldwide: 1906 domestic, 1180 international, 55 demos/in-house
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
HardyCHROM 0157, Catalogue Number: G305, Packaged: 10 plates per sleeve, Recall # Z-0078-2007
CODE
Lot numbers: 06192, exp. 10/09/2006 and 06235, exp. 10/22/2006
RECALLING FIRM/MANUFACTURER
Hardy Media Inc., Dba Hardy Diag, Santa Maria, CA, by telephone, fax and letter on August 21, 2006 and by letter September 25, 2006. Firm initiated recall is ongoing.
REASON
This recall is being conducted due to performance failure; the product is failing to show pigment development for E. coli 0157.
VOLUME OF PRODUCT IN COMMERCE
850 plates
DISTRIBUTION
Nationwide
______________________________
PRODUCT
ConMed DetachaTip® Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1019. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0083-2007;
ConMed DetachaTip® Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4319. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility Recall # Z-0084-2007;
ConMed DetachaTip® Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1005. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0085-2007;
ConMed DetachaTip® Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4305. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0086-2007;
ConMed DetachaTip® Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1009. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0087-2007;
ConMed DetachaTip® Laparoscopic Instrument: Curved ''Maryland'' Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4308. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0088-2007;
ConMed DetachaTip® Laparoscopic Instrument: Endoweave Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4328. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0089-2007;
ConMed DetachaTip® Laparoscopic Instrument: Fenestrated (Duckbill) Multiple Use Grasper, 5mm x 43cm, REF/Product Code 1-4307. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0090-2007;
ConMed DetachaTip® Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1017. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0091-2007;
ConMed DetachaTip® Laparoscopic Instrument: Meeker (Right Angle) Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4317. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0092-2007;
ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-006. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0093-2007;
ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-436. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0094-2007;
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6047-001. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0095-2007;
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0096-2007;
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-002. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0097-2007;
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-432. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0098-2007;
ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-005. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0099-2007;
ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-435. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0100-2007;
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-003. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0101-2007;
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-433. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0102-2007;
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0103-2007;
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-434. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0104-2007;
ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-006. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0105-2007;
ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-436. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0106-2007;
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-002. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0107-2007;
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-432. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0108-2007;
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-005. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0109-2007;
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-435. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0110-2007;
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-003. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0111-2007;
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-433. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0112-2007;
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-004. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0113-2007;
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-434. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility, Recall # Z-0114-2007;
CODE
REF/Product Code 1-1019, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-4319, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-1005, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-4305, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-1009, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-4308, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-4328, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-4307, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-1017, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 1-4317, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6045-006, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
Product Code 60-6045-436, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6047-001, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month;
REF/Product Code 60-6047-431, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6045-002, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6045-432, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6045-005, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6045-435, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6045-003, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6045-433, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6045-004, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6045-434, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6040-006, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6040-436, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.];
REF/Product Code 60-6040-002, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6040-432, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6040-005, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6040-435, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6040-003, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6040-433, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6040-004, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
REF/Product Code 60-6040-434, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
RECALLING FIRM/MANUFACTURER
Conmed Corporation, Utica, NY, by letter dated October 1, 2006. Firm initiated recall is ongoing.
REASON
The grasper jaws broke during Laparoscopic procedures at the junction of the jaw and the tube.
VOLUME OF PRODUCT IN COMMERCE
9,913 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
Venoscope Neonatal Transilluminator, Model NT01, Recall # Z-0116-2007
CODE
No coding on the exterior of the device.
RECALLING FIRM/MANUFACTURER
Venoscope LLC, Lafayette, LA, by telephone beginning on April 28, 2006. Firm initiated recall is complete.
REASON
Excessive heating due to incorrect wire assembly process.
VOLUME OF PRODUCT IN COMMERCE
118 devices
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Recall # Z-0118-2007
CODE
Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #''s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units). Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #''s; W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
RECALLING FIRM/MANUFACTURER
Enpath Medical, Inc., Plymouth MN, by letter on June 29, 2006 and by telephone on June 27, and July 6, 2006. Firm initiated recall is ongoing.
REASON
Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.
VOLUME OF PRODUCT IN COMMERCE
2,429 units
DISTRIBUTION
CA, and MA
______________________________
PRODUCT
First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other first aid supplies, various sizes, - travel size, all purpose, first aid response kit, on-the-road, recreational, outdoor, Recall # Z-0145-2007;
First Aid kits, Pharmacist's Choice, containing acetaminophen and a variety of first aid items, all purpose first aid kit, Recall # Z-0146-2007;
First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a variety of first aid supplies. Recall # Z-0147-2007
CODE
Kit codes C-0054, C-0094, C-0104, C-0114, C-0124, C-0154, C-0164, C-0174, C-0184, C-0194, C-0224, C-0234, C-0244, C-0294, C-0304, C-0294, C-0164, B-0264, C-0314, C-0104, C-0224, C-0314, C-0104, C-0294, D-0024, D-0064, D-0084, D-0134, D-0264, C-0104, C-0094, E-0134, F-0074, G-0194 Acetaminophen coded 03M847, expiration 12/06;
Kit codes C-0124, C-0294 Acetaminophen coded 03M847, expiration 12/06;
Kit code C-0234, C-0244, C-0254, C-0264 Acetaminophen coded 03M847, expiration 12/06
RECALLING FIRM/MANUFACTURER
First Aid Only Inc, Vancouver, WA, by letter dated August 17, 2006. Firm initiated recall is ongoing.
REASON
Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
365,298 kits
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
VITROS® WorkCentre, Catalog # 6802159, using enGen™ Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.'s branded version of Instrument Manager™, Recall # Z-0077-2007
CODE
Version 8.04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester NY, by letters dated March 6, 2006.
Manufacturer: Data Innovations, Inc., South Burlington, VT. Firm initiated recall is ongoing.
REASON
Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre).
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
Tosoh AIA-Pack Folate Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box, Recall # Z-0082-2007
CODE
Lot Code: G431726, Expiration Date: April, 2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tosoh Bioscience Inc, Grove City OH, by letters on September 5, 2006.
Manufacturer: Tosoh Corporation, Minato-Ku 43123, Japan. Firm initiated recall is ongoing.
REASON
Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument.
VOLUME OF PRODUCT IN COMMERCE
151 boxes
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990, Recall # Z-0122-2007
CODE
Lot Number: 7552069
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by recall notification packages on August 10, 2005.
Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is complete.
REASON
Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR November 8, 2006
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