Safety
Enforcement Report for October 20, 2010
October 20, 2010 10-41
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
Suzipoo Lobster Poo Candy (4 oz) bag UPC: 8935881126. Recall # F-0009-2011
CODE
All codes
RECALLING FIRM/MANUFACTURER
Sue Pollard Entertainment, Ogunquit, ME, by telephone on September 9, 2010 and visits, and by press release on September 22, 2010. Maine initiated recall is complete.
REASON
Product contains undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
288 bags
DISTRIBUTION
ME
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PRODUCT
La Nuestra brand mamey pulp comes in a 14-ounce plastic package - UPC is 7-56869-10008-4. Recall # F-0010-2011
CODE
All lot numbers and packages produced prior to May 2009 that are not identified with a lot number
RECALLING FIRM/MANUFACTURER
Recalling Firm: Montalvan's Sales, Inc., Ontario, CA, by press release on August 19, 2010.
Manufacturer: COCO S.A., Guatemala. FDA initiated recall is ongoing.
REASON
Frozen Mamey Pulp is potentially implicated via a strong epidemiologic link to a recent outbreak of Typhoid Fever in several Western States.
VOLUME OF PRODUCT IN COMMERCE
12,070 (144,840 retail units – 12 per case)
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Torn & Glasser - Mixed Nuts Fancy, No Peanuts - 3.75lb can (#10) - UPC: 072488980761. Recall # F-0011-2011
CODE
Lot numbers 0980 and 1940
RECALLING FIRM/MANUFACTURER
Torn & Glasser Inc., East Rancho Dominguez, CA, by press release and letters beginning August 24, 2010. Firm initiated recall is ongoing.
REASON
This recall was initiated after Torn & Glasser discovered a labeling error in which their 3.75 lb. cans of "Mixed Nuts Fancy, No Peanuts" was labeled as not containing any peanuts.
VOLUME OF PRODUCT IN COMMERCE
61 cases
DISTRIBUTION
CA, HI, NY, WA
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PRODUCT
1) Taste Good Egg Noodles; fresh frozen egg noodles; Packaged in plastic bags, Net Wt. 5 Lbs. (2.27 kg), 10 bags per case. Recall # F-0032-2011;
2) Wonton Wrappers; fresh frozen wonton wrappers, 4" x 4" or 3.5" x 3.5"; Packaged in paper wrappers, 5 lbs. each, 6 packages per case. Recall # F-0033-2011
CODE
All products manufactured/shipped between June 19, 2010 and August 19, 2010.
RECALLING FIRM/MANUFACTURER
Good Taste Noodle Manufacturing, Inc., Chicago, IL, by letter dated August 30, 2010. FDA initiated recall is ongoing.
REASON
The fresh frozen egg noodles and wonton wrappers were manufactured using eggs recalled due to potential contamination with Salmonella enteritidis.
VOLUME OF PRODUCT IN COMMERCE
5,850 cases
DISTRIBUTION
IL, KY, MN, WI
_____________________________________
PRODUCT
Whole Foods Morningland Dairy and Ozark Hills Farm Raw Goat Milk Mild Cheddar Cheese. Recall # F-0034-2011
CODE
All Use By Dates
FIRM/MANUFACTURER
Recalling Firm: Whole Food Market, Cambridge, MA, by e-mail on September 1, 2010 and by press release on September 2, 2010.
Manufacturer: Morningland Farm Inc., Mountain View, MO. Firm initiated recall is complete.
REASON
Product may be contaminated with Listeria monocytogenes and Staphylococcus aureus.
VOLUME OF PRODUCT IN COMMERCE
640 lbs (21x 40 lbs)
DISTRIBUTION
CT, MA
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PRODUCT
1) Queso El Azteca brand QUESO FRESCO (Fresh White Cheese), Net Wt. 14 oz. (396g), UPC 0 23986 92692 8. The product is packed in a clear, hard plastic (clam shell) container. Recall # F-0035-2011;
2) Queso El Azteca brand QUESO HEBRA (Fresh White String Cheese), Net Wt. 14 oz. (396g) and Net Wt. 5 Lbs. (2.25K). The product is packaged in a vacuum sealed plastic bag. Recall # F-0036-2011;
3) Queso El Azteca brand REQUESON (Ricotta Cheese), Net Wt. 14 oz. (396g). The product is packaged in a hard plastic (clam shell) container. Recall # F-0037-2011
CODE
1) Expiration date SEP 11 2010; recall expansion: expiration date SEP 12 2010
2) Expiration date SEP 11 2010;
3) Expiration date SEP 19 2010
FIRM/MANUFACTURER
Azteca Linda Corp., Brooklyn, NY, by telephone on August 23, 2010 and August 30, 2010, by press release on August 24, 2010 and September 1, 2010 and by letters dated August 24, 2010 and September 1, 2010. Rhode Island initiated recall is ongoing.
REASON
The cheese product was found to be contaminated with Listeria monocytogenes based on sampling and analysis by the Rhode Island Department of Health.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2100 units
DISTRIBUTION
NY, RI
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PRODUCT
1) Morningland Dairy raw milk cheese Mild Cheddar, packaged in random-weight vacuum packed retail packages. Recall # F-0038-2011;
2) Morningland Dairy raw milk cheese Med. Sharp Cheddar, packaged in random-weight vacuum packed retail packages. Recall # F-0039-2011;
3) Morningland Dairy raw milk cheese Sharp Cheddar, packaged in random-weight vacuum packed retail packages. Recall # F-0040-2011;
4) Morningland Dairy raw milk cheese Colby, packaged in random-weight vacuum packed retail packages. Recall # F-0041-2011;
5) Morningland Dairy raw milk cheese Hot Pepper Colby, packaged in random-weight vacuum packed retail packages. Recall # F-0042-2011;
6) Morningland Dairy raw milk cheese Garlic Colby, packaged in random-weight vacuum packed retail packages. Recall # F-0043-2011;
7) Morningland Dairy raw milk cheese Italian Colby, packaged in random-weight vacuum packed retail packages. Recall # F-0044-2011;
8) Morningland Dairy raw milk cheese Dill Colby, packaged in random-weight vacuum packed retail packages. Recall # F-0045-2011;
9) Morningland Dairy raw milk cheese No-Salt Added Mild Cheddar, packaged in random-weight vacuum packed retail packages. Recall # F-0046-2011;
10) Ozark Hill Farms Goat Milk Cheese, Raw Milk Cheddar, packaged in random-weight vacuum packed retail packages. Recall # F-0047-2011;
11) Ozark Hill Farms Goat Milk Cheese, Raw Milk Cheddar Medium Sharp, packaged in random-weight vacuum packed retail packages. Recall # F-0048-2011;
12) Ozark Hill Farms Goat Milk Cheese, Raw Milk Cheddar Sharp, packaged in random-weight vacuum packed retail packages. Recall # F-0049-2011;
13) Ozark Hill Farms Goat Milk Cheese, Raw Milk Colby, packaged in random-weight vacuum packed retail packages. Recall # F-0050-2011;
14) Ozark Hill Farms Goat Milk Cheese, Raw Milk Colby - Hot Pepper, packaged in random-weight vacuum packed retail packages. Recall # F-0051-2011;
15) Ozark Hill Farms Goat Milk Cheese, Raw Milk Colby - Garlic-N-Chive, packaged in random-weight vacuum packed retail packages. Recall # F-0052-2011;
16) Ozark Hill Farms Goat Milk Cheese, Raw Milk Colby - Italian, packaged in random-weight vacuum packed retail packages. Recall # F-0053-2011
CODE
1) – 16) A10 (January 1, 2010) through F250 (June 25, 2010)
FIRM/MANUFACTURER
Morningland of the Ozarks, LLC dba Morningland Dairy, Mountain View, MO, by press release and telephone on August 30, 2010 and by letters between September 3, September 4, 2010. California initiated recall is ongoing.
REASON
The cheese has the potential to be contaminated with Listeria monocytogenes and Staphylococcus aureus.
VOLUME OF PRODUCT IN COMMERCE
48,412.18 lbs. cheese from cow's milk and 7,361.15 lbs. cheese from goat's milk
DISTRIBUTION
Nationwide
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PRODUCT
1) Pistachio Kernels- Raw, distributed in 25 lb and 50 lb bags (bulk). Recall # F-0055-2011;
2) Austinuts Deluxe Nut Mix, Dry Roasted Salted, Net Wt 4 oz (113g) UPC 98612 13204; and 8 oz (227g) UPC 98612 13208; packaged in 4 oz and 8 oz bag, and 25 lb bag. Recall # F-0056-2011;
3) Austinuts Gourmet Nut Mix, Dry Roasted Salted, Net Wt 4 oz (113g) UPC 98612 14404 and Net Wt 8 oz (227g) UPC 98612 14408, packaged in 4 oz and 8 oz bag or box. Recall # F-0057-2011;
4) Austinuts Pistachio Kernels, Dry Roasted Salted, Net Wt 4 oz (113g) UPC 98612 12404; and Net Wt 8 oz (227g) UPC 98612 12408; packaged in 4 oz and 8 oz bag or box UPC; and 25 lb bag (bulk). Recall # F-0058-2011
CODE
1) Lot numbers ending with "SE" with packing codes of P1860 through P2080;
2) Lot numbers P187013201AW through P207013201AW;
3) Lot numbers: P187013201AW through P201014401AW;
4) Lot numbers ending with "SE" with packing codes of P1860 through P2080
RECALLING FIRM/MANUFACTURER
Recalling Firm: Austinuts Wholesale, Inc., Manor, TX, by e-mail and telephone on August 19, 2010.
Manufacturer: Austinuts Wholesale, Inc., Manor, TX. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,394 lbs
DISTRIBUTION
TX
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
1) Similac � Early Shield Go & Grow Complete Toddler Nutrition Milk Based Infant Formula with Iron DHA/ARA 9-24 Months Specially designed to support your toddler's immune system, Powder 8 oz & 22 oz plastic container, Case UPC, 070074563855, 070074508276, Unit UPC, 070074563862 & 070074508276. Recall # F-0012-2011;
2) Similac � Go & Grow Milk-Based Formula with Iron Powder DHA/ARA Specially designed for older babies 9-24 Months 12.9 oz, 22 oz & 24 oz, plastic container, Case UPC: 070074508276, 070074577074, 070074577098, 070074508276, 070074577074, 070074577098, Unit UPC: 070074508283, 070074577081, 070074577104, 070074508283, 070074577081 & 070074577104. Recall # F-0013-2011;
3) Similac � Early Shield Immune Support Strong Bones Brain & Eye Go & Grow Soy-Based Formula with Iron DHA/ARA Complete Toddler Nutrition 9-24 Months Powder 22 oz, plastic container, Case UPC: 070074508375, Unit UPC: 070074508375. Recall # F-0014-2011;
4) Similac � Go & Grow " Soy-Based Formula DHA/ARA Powder 9 to 24 Months Milk-Free, Lactose-Free with Iron Specially designed for older babies 12.9 oz, 22 oz & 24 oz plastic container, Case UPC: 070074508375, 070074577111, 070074577135, Unit UPC: 070074508382, 070074577128 & 070074577142. Recall # F-0015-2011;
5) Similac � Sensitive Isomil Soy " For Fussiness & Gas Early Shield Immune Support Strong Bones Brain & Eye #1 Formula for Complete Soy Nutrition Powder 8 oz , 23.2 oz & 34 oz, plastic containers, Case UPC: 070074563022, 070074508191, 070074508252, Unit UPC: 070074563039, 070074508191 & 070074508252. Recall # F-0016-2011;
6) Similac � Isomil � Advance Soy Formula DHA/ARA For Fussiness, Gas & Spit-Up Powder Easy to digest Milk-Free, Lactose-Free with Iron 8 oz, 12.9 oz, 23.2 oz, 25.7 oz 34 oz, & 36 oz plastic containers, Case UPC: 070074508191, 070074508252, 070074559636, 070074559650, 070074574950, 070074575940, 070074579078, 070074585987 Unit UPC: 070074508207, 070074508269, 070074559643, 070074559667, 070074579085 & 070074585994. Recall # F-0017-2011;
7) Similac � Isomil � Soy Formula Milk-Free Lactose-Free For Fussiness, Gas and Spit-up with Iron Powder 12.9 oz plastic container Case UPC, 070074577623, Unit UPC, 070074577630. Recall # F-0018-2011;
8) Similac � Advance Infant formula with Iron Early Shield Immune Support Strong Bones Brain & Eye Complete Nutrition for Your Babys 1st Year Milk-Based DHA/ARA Powder 8, 12.4, 12.9, 23.2 & 34 oz in plastic container, Case UPC, 070074533575, 070074533599, 070074534503, 070074534961, 070074536439, 070074536538, 070074559575, 070074559575, Unit UPC, 070074533582, 070074533605, 070074105840, 070074534978, 070074536545, 070074559575 & 070074559575. Recall # F-0019-2011;
9) Similac � Advance Infant Formula with Iron DHA/ARA Powder special nutrients found in breast milk 8 oz, 12.9 oz, 23.2 oz, 25.7 oz, 30.8 oz & 36 oz plastic container, Case UPC: 070074507590, 070074579115, 070074585871, 070074559575, 070074559599, 070074574783, 070074575933, 070074585857, Unit UPC: 070074507606, 070074573472, 070074585888, 070074559582, 070074559605 & 070074585864. Recall # F-0020-2011;
10) Similac � Organic Infant Formula with Iron Powder Made with organic milk DHA/ARA special nutrients found in breast milk 12.9 oz, 23.2 & 34 oz plastic container, Case UPC: 070074508153, 070074508214, 070074595436, Unit UPC: 070074508160, 070074508221 & 070074595443. Recall # F-0021-2011;
11) Similac � Sensitive with Iron For Fussiness & Gas Due to Lactose Sensitivity Early Shield Immune Support Strong Bones Brain & Eye Complete Nutrition for Sensitive Tummies Milk-Based Powder 8 oz, 23.2 oz, 34 oz plastic container, Case UPC: 070074563527, 070074508177 & 070074534459; Unit UPC: 070074563534, 070074508177 & 070074534459. Recall # F-0022-2011;
12) Similac � Sensitive Infant Formula with Iron For Spit-Up In Healthy Infants Complete Nutrition for Sensitive Tummies Milk-Based DHA/ARA Powder 23.2 oz, plastic container, Case UPC: 070074537290, Unit UPC: 070074537306. Recall # F-0023-2011;
13) Similac � Sensitive Infant Formula with Iron For Fussiness & Gas due to lactose sensitivity Easy to digest Milk-Based, Lactose-Free DHA/ARA Powder 8 oz, 23.2 oz & 34 oz plastic container, Case UPC: 070074508177, 070074534459, 070074577159, Unit UPC: 070074508184 & 070074534466. Recall # F-0024-2011
CODE
1) Lot #'s: 78213T2, 78213T21, 79432T2, 79433T2, 79525T2, 79526T2, 79527T2, 79528T2, 88158T26, 88158T26, 88158T26, 88158T26, 81673T2, 81674T2, 81675T2, 81995T2, 82865T2, 82866T2, 82867T2, 82974T2, 82975T2, 82976T2, 83093T2, 83094T2, 83094T2, 83095T2, 84275T2, 84275T2, 84275T2, 84275T2, 84275T2, 84276T2, 84277T2, 85444T2, 85445T2, 85446T2, 85495T20, 85496T20, 85497T20, 86655T20, 86656T20, 86657T20, 86766T20, 86772T20, 86773T20, 86805T20, 86805T21, 86806T20, 86807T20, 87939T20, 87940T20, 87941T20, 87941T20, 87942T20, 87966T21, 87966T21, 88158T20, 88159T20, 88159T20, 88160T20, 90316T20, 90316T26, 90316T26, 90317T20, 91457T20, 91458T20, 91482T20, 92665T20, 92699T20, 92700T20, 92701T20 & 93773T20;
2) Lot #s: 57826T26, 57827T26, 58828T26, 58829T26, 58830T26, 58831T26, 58831T26, 58955T26, 58956T26, 58957T26, 58958T26, 59001T26, 59043RB6, 60195T26, 60195T26, 60196T26, 60197RB6, 60198T26, 60199T26, 62511T26, 62512T26, 62512T26, 62513T26, 62514T26, 62515T26, 62516T26, 65046T26, 65046T26, 65049T26, 65050T26, 65051T26, 65052T26, 65053T26, 65054T26, 65054T26, 65055T26, 65056RB6, 68470T26, 68575T26, 68576T26, 69839T2, 69839T2, 69840T2, 69840T2, 69841T2, 69841T2, 69842T2, 69843T2, 69898T26, 69899T26, 69900T26, 70997T2, 70998T2, 71204T2, 71205T2, 75806T2, 75807T2, 75808T2, 76017T2, 76018T2, 76047T2, 76048T2, 78297T2, 78297T2, 78298T2, & 79468T2;
3) Lot #s: 87007T20, 87007T20, 87007T20, 87008T20, 87009T20, 87837T20, 89244T20, 91433T20, 92607T20 & 92702T20;
4) Lot #s: 58994T26, 58995T26, 58996RB6, 58997T26, 58998T26, 58999T26, 60151T26, 60152T26, 62503T26, 62539T26, 62540T26, 65950T26, 65995RB6, 65996T26, 68456T26, 68632T26, 68633T26, 69743T26, 70930T26, 70931T26, 75877T2, 75878T2, 75879T2, 76995T2, 76996T2, 77161T2, 77162T2, 79434T2, 80598T2, 80599T2, 80600T2, 81736T2, 81737T2, 81738T2, 82002T2, 82116T2, 84294T2, 84295T2 & 86537T2;
5) Lot #s: 87002T20, 87003T20, 87004T20, 87005T20, 87006T20, 87006T20, 87065T20, 87840T20, 87840T26, 8100T20, 88101T20, 88102T20, 88103T20, 89228T20, 89228T21, 89228T26, 89229T20, 89238T20, 89238T20, 89239T20, 89240T20, 89240T21, 89241T20, 89242T20, 89243T20, 90393T26, 90400T20, 90400T21, 90401T20, 90401T20, 91429T20, 91430T20, 91430T26, 91430T26, 91431T20, 91432T20, 91515T20, 91516T20, 92603T20, 92604T20, 92604T26, 92605T20, 92606T20, 92703T20, 92703T21, 92703T26, 92704T20, & 92705T20;
6) Lot #s: 59047RB6, 59083RB6, 59084RB6, 59085RB6, 59086RB6, 59087RB6, 59088RB6, 59088RB7, 59089RB6, 60127T26, 60128T26, 60129T26, 60130T26, 60154RB6, 60155RB6, 60156RB6, 61193RB6, 61260T26, 61261RB6, 61262RB6, 61263RB6, 61264RB6, 61265RB6, 61269T26, 61270T26, 61271T26, 61272T26, 61273RB6, 62448RB6, 62449RB6, 62450RB6, 62451T26, 62466T26, 62467T26, 62496T26, 62497T26, 62498T26, 62499RB6, 62500RB6, 62501RB6, 62502RB6, 62536RB6, 62537RB6, 62538RB6, 63555T26, 63556T26, 63557T26, 63558T26, 63559T26, 63599T26, 63715T26, 65014RB6, 65015RB6, 65016RB6, 65017RB6, 65946RB6, 65947RB6, 65948RB6, 65949T26, 65998RB6, 661507Y, 66196T27, 66197T26, 66197T26, 68437RB6, 68438RB6, 68453RB6, 68454RB6, 68454RB6, 68457RB6, 68458RB6, 68459RB6, 68460RB6, 68509RB6, 68510RB6, 68511RB6, 68512RB6, 68512RB7, 68513RB6, 68605RB6, 68606RB6, 68607RB6, 709267Y, 709267Y10, 709617Y, 709617Y10, 73571RB, 73572RB, 73573RB, 73574RB, 73575RB, 73588RB, 73588RB, 75827T2, 75827T21, 75861T2, 75862T2, 75868T2, 75869T2, 75869T2, 75870T2, 75871T2, 75872T2, 75873T2, 75874T2, 76989T2, 76989T2, 76990T2, 76991T2, 76992T2, 76992T2, 76993T2, 76993T21, 76993T21, 77085RB, 77085T2, 77085T2, 77153T2, 77156T21, 77157T2, 77158T2, 77159T2, 77159T2, 77159T2, 78171T2, 78173T2, 78174T2, 78198T21, 79366T2, 79367T2, 79368T2, 79369T2, 79370T2, 80585T2, 80586T2, 80587T2, 80588T2, 80589T2, 80590T2, 80591T2, 80591T2, 80592T2, 80593T2, 80594T2, 80595T2, 80596T2, 80597T2, 81693T2, 81694T2, 81695T2, 81696T2, 81697T2, 81699T2, 81700T2, 81701T2, 81733T2, 81733T21, 81734T2, 82004T2, 82005T2, 82006T2, 82007T2, 82009T2, 82009T21, 82077T2, 82138T2, 82139T2, 82140T2, 82192T2, 84296T2, 84296T21, 84304T2, 84305T2, 84306T2, 84307T2, 84308T2, 84309T2, 84412T2, 84509T2, 85427T2, 85428T2, 85429T2, 85430T2, 85431T2, 85432T2, 86539T20, 86540T20, 86540T20, 86541T20, 86541T20, 86542T20, 87066T20, 87841T20, 87841T20, 87900T20 & 87901T20;
7) Lot #: 62447RB6;
8) Lot #s: 66185RB6, 66185RB6, 66185RB6, 66186RB6, 66187RB6, 66188RB6, 66194RB6, 67245RB6, 67246RB6, 673747Y, 673747Y, 673897Y, 673897Y10, 673907Y, 673927Y, 673927Y10, 673997Y, 674007Y, 674007Y, 674047Y, 674047Y10, 674057Y, 68429RB6, 68542RB6, 68543RB6, 68544RB6, 68582RB6, 68583RB6, 68583RB6, 69704RB6, 69707RB6, 697457Y, 697467Y, 697477Y, 97477Y10, 697737Y, 697747Y, 69775RB, 697857Y, 697857Y10, 70046RB, 70099RB, 70100RB, 709997Y, 711057Y, 711377Y, 712077Y, 74705RB, 74706RB, 74707RB, 74748T2, 74748T2, 74748T2, 74748T2, 74749RB, 74750RB, 74751RB, 75799T2, 75800T2, 75801T2, 75802T2, 75803T2, 75804T2, 75805T2, 75805T21, 75835T2, 75836T2, 75839T2, 75840T2, 75840T21, 75841RB, 75842RB, 75843RB, 75844RB, 75847RB, 75848RB, 75903T2, 75903T21, 75904RB, 75905RB, 75906T2, 75907T2, 75908T2, 75909T2, 75910T2, 75911T2, 75911T2, 75912T2, 75913T2, 75919T2, 76008T2, 76009T2, 76010T2, 76011T2, 76012T2, 76013T2, 76014T2, 76015RB, 76016RB, 76022T2, 76023T2, 76024T2, 76025T2, 76026T2, 76027T2, 76028T2, 76029T2, 76030T2, 76031T2, 76032RB, 76033RB, 76033RB, 76036T2, 76037T2, 76038T2, 76039T2, 76040T2, 76041T2, 76042T2, 76043T2, 76044T2, 76045RB, 76046RB, 76051T2, 76052T2, 76053T2, 76054T2, 76055T2, 76056T2, 76057RB, 76058RB, 76059T2, 76060T2, 76061T2, 76062T2, 76063T2, 76066T2, 76067T2, 76068T2, 76069T2, 76069T2, 76070RB, 76071RB, 76072RB, 76073T2, 76074T2, 76075T2, 76076T2, 76076T2, 76077T2, 76078RB, 77186T2, 77187T2, 78181T2, 78182RB, 78183RB, 78183RB1, 78184RB, 78184T2, 78185T2, 78200RB, 78201T2, 78201T21, 78202T2, 78203T2, 78204T2, 78205RB, 78211T2, 78212RB, 78214T2, 78215T2, 78216T2, 78217RB, 78237T2, 78238T2, 78238T21, 78239T2, 78240T2, 78241T2, 78287T2, 78288T2, 78289T2, 78290T2, 78291RB, 78292T2, 78293T2, 78294T2, 78295T2, 78296T2, 78303T2, 78303T2, 78304T2, 78305T2, 78306T2, 78307T2, 78308RB, 78308RB, 78309T2, 78309T21, 78310RB, 78311T2, 78312T2, 78313T2, 78314RB, 78315RB, 79361RB, 79362T2, 79364T2, 79386T2, 79387T2, 79388T2, 79389T2, 79390T2, 79415T2, 79416T2, 79416T21, 79418T2, 79419T2, 79420T2, 79421T2, 79422T2, 79423T2, 79424T2, 79425T2, 79426T2, 79452T2, 79453T2, 79454T2, 79455T2, 79500T2, 79515T2, 79518T2, 79519T2, 79520T2, 79521T2, 79522T2, 79523T2, 79524T2, 79529T2, 79531T2, 79532T2, 79533T21, 79533T22, 79533T23, 79534T2, 79535T2, 79536T2, 79537T2, 79537T22, 79538T2, 79574T2, 79575T2, 79576T2, 80627RB, 80627RB, 80628T2, 80629RB, 80630T2, 80631T2, 80632T2, 80633T2, 80634T2, 80635T2, 80636T2, 80643RB, 80644T2, 80645RB, 80646RB, 80647RB, 80648T2, 80648T2, 80649T2, 80650T21, 80651T2, 80652T2, 80653T2, 80654T2, 80655T2, 80657T2, 80658RB, 80659T2, 80660RB, 80661RB, 80662T2, 80663T2, 80664T2, 80665T2, 80667T2, 81671T2, 81672T2, 81676T2, 81677T2, 81678T2, 81679T2, 81680T2, 81681T2, 81682T2, 81683T2, 81684T2, 81685T2, 81686T2, 81687RB, 81688RB, 81689RB, 81690RB, 81691T2, 81798RB, 81854RB, 81855RB, 81856RB, 81857RB, 81858RB, 81859RB, 82010T2, 82011T2, 82012T2, 82013T2, 82014T2, 82073T2, 82143RB6, 82144RB6, 82144RB6, 82860RB, 82861T2, 82862T2, 82863T2, 82864T2, 82881RB, 82888T2, 82889T2, 82890T2, 82891RB, 82928T2, 82929T2, 82930T2, 82931T2, 82932RB, 82932RB1, 82933T2, 82934T2, 82935T2, 82936RB, 82937RB, 82938T2, 82939RB, 82940RB, 82941RB, 82942RB6, 82942RB6, 82943RB, 82981T2, 82982T2, 82983T2, 82984T2, 82985T2, 82989RB, 82990T2, 82991T2, 82994RB, 83039T2, 83040T2, 83041T2, 83042T2, 83043T2, 83044T2, 83045T2, 83046RB, 83047RB, 83047RB1, 83048RB6, 83049RB6, 83078RB6, 83079RB6, 83080RB6, 83081RB6, 83082RB6, 83082RB6, 83083RB6, 83086RB6, 83087RB6, 83088RB6, 83089RB6, 83090RB6, 83091T2, 83092T2, 83100T2, 83101RB6, 83102T2, 83103T2, 83103T21, 83104T2, 83105T2, 83106RB, 83107T2, 83117T2, 83118RB, 83119RB, 83120T2, 83121T2, 83122T2, 83123T2, 83124T2, 83125T2, 83126T2, 83127RB, 83128RB, 83129RB, 83129RB, 83130RB, 83131RB, 83132T2, 83207T2, 83208T2, 83209T2, 83210RB, 83211RB, 83212RB, 83213RB, 83214RB, 83215RB, 83216RB, 83217T2, 83217T21, 83217T26, 83218T2, 83219T2, 83220RB, 83221RB, 83224RB, 83225RB, 83226RB, 83227RB, 84265T2, 84266T2, 84267T2, 84268T2, 84269T2, 84270T2, 84271T2, 84272RB, 84273RB, 84283T2, 84284T2, 84285T2, 84286T2, 84287T2, 84288RB, 84289RB, 84290RB, 84291RB, 84292RB, 84293RB, 84312T2, 84313T2, 84314RB, 84315RB, 84315RB1, 85316T2, 85326T2, 85327T2, 85328T2, 85329T2, 85330RB, 85335T2, 85336T2, 85337RB, 85338T2, 85339T2, 85447RB, 85448RB, 85449RB, 85450T2, 85451RB, 85452T2, 85453T2, 85454T2, 85455RB, 85456RB, 85457RB, 85457RB1, 85458RB, 85459RB, 85460RB, 85461T2, 85462T2, 85463T2, 85464RB, 85465RB, 85470T2, 85471T2, 85472T2, 85473T2, 85474RB, 85475RB, 85476RB, 85477RB, 85478RB, 85479RB, 85480T2, 85481T2, 85484T2, 85485RB, 85486RB, 85487RB, 85487RB, 85488RB, 85489T2, 85490T2, 85491T2, 85492RB, 85498RB, 85499T2, 85500T2, 85501T2, 85501T2, 85501T2, 85502T2, 85502T2, 85502T2, 85502T2, 85503T2, 85503T2, 85506T2, 85507T2, 85508T2, 85545RB, 85619T2, 85620T2, 85621T2, 86544RB, 86585RB6, 86586RB6, 86587RB6, 86588RB6, 86589T20, 86590RB6, 86590RB7, 86592RB6, 86594T20, 86595T20, 86596T20, 86602T20, 86650T20, 86651T20, 86763T20, 86764T20, 86765T20, 86767T20, 86768RB6, 86769RB6, 86770RB6, 86771RB6, 86776T20, 86777T20, 86793RB6, 86794RB6, 86795RB6, 86796RB6, 86797RB6, 86798RB6, 86799RB6, 86800RB7, 86801RB7, 86802RB7, 86803RB7, 87022T20, 87131T20, 87132T20, 87831RB6, 87832RB6, 87833RB6, 87834RB6, 87835RB6, 87836RB6, 87846T20, 87846T20, 87847T20, 87848T20, 87849T20, 87850T20, 87850T20, 87851T20, 87852T20, 87880T20, 87881T20, 87882T20, 87883T20, 87884T20, 87885T20, 87885T21, 87886T20, 87887RB6, 87888RB6, 87889RB6, 87890T20, 87891T20, 87892T20, 87923RB7, 87924RB7, 87934T20, 87935T20, 87936T20, 87937T20, 87938T20, 87938T20, 87967T20, 87968T20, 87969T20, 87970T20, 87971T20, 87971T21, 87995T20, 87996T20, 87997T20, 87998T20, 87999T20, 88031T20, 88032T20, 88033T20, 88034T20, 88035T20, 88035T26, 88036T20, 88036T26, 88037T20, 88038T20, 88039T20, 88040T20, 88041T20, 88042T20, 88042T26, 88043T20, 88106T20, 88107T20, 88108T20, 88109T20, 88110T20, 88111T20, 88112T20, 88113T20, 88114T26, 88115T20, 88115T20, 88115T21, 88116T20, 88133T20, 88134T20, 88135T20, 88136T20, 88137T20, 88138T20, 88139T20, 88139T20, 88156T20, 88157RB6, 88161T20, 88162T20, 88163T20, 88164T20, 88165T20, 88166T20, 88166T20, 88166T20, 88166T20, 88193RB6, 88194RB6, 88195RB6, 88196RB6, 88197RB6, 88198RB6, 88199T20, 88199T20, 88199T20, 88199T20, 88199T20, 88200T20, 88201T20, 88202T20, 88203RB6, 89221RB6, 89223RB6, 89223RB6, 89223RB6, 89233T20, 89234T20, 89235T20, 89236T20, 89237T20, 89245T20, 89245T21, 89246RB6, 89246T21, 89248T20, 89249T20, 89250T20, 89250T20, 89251T20, 89252T20, 89252T21, 89253T20, 89254T20, 89255T20, 89256T20, 89256T26, 89256T26, 89257T20, 89313T20, 90314T20, 90315T20, 90334T20, 90335T20, 90339T20, 90340T20, 90341T20, 90341T26, 90346T20, 90347T20, 90368T20, 90369T20, 90369T21, 90374T20, 90375T20, 90375T21, 90376T20, 90377T20, 90377T21, 90394T20, 90394T20, 90395T20, 90395T21, 90396T20, 90397T20, 90398T20, 90399T20, 90404T20, 90423T20, 90426T20, 90427RB6, 90427RB6, 91483T26, 91483T26, 91484T20, 91485T20, 91486T20, 91487T20, 91488T20, 91489T20, 91489T26, 91496T20, 91497T20, 91543T20, 91543T26, 91544T20, 91545T20, 91546T20, 91547T20, 91547T26, 91570T20, 91570T26, 91571T20, 91572T20, 91573T20, 91573T26, 91574T20, 91575T20, 91576T20, 91577T20, 91578T20, 92582T20, 92582T26, 92583T20, 92584T20, 92585T20, 92586T20, 92587T20, 92600RB6, 92601RB6, 92602T20, 92608T20, 92609T20, 92610T20, 92610T26, 92611T20, 92614T20, 92615T20, 92616T20, 92662T20, 92662T21, 92663T20, 92672T20, 92673T20, 92674T20, 92674T26, 92675T20, 92676T20, 92677T20, 92677T26, 92693T20, 92694T20, 92695T20, 92696T20, 92697T20, 92698T20, 92706RB6, 92721T20 & 93763T20;
9) Lot #'s: 57713T26, 57713T26, 57713T26, 57713T26, 57714T26, 57714T26, 57714T26, 57715RB6, 57716RB6, 57717RB6, 57718RB6, 57719T26, 57720T26, 57721T26, 57739RB6, 57740RB6, 57741RB6, 57742RB6, 57743RB6, 57744RB6, 57745RB6, 57749RB6, 57749RB7, 57749RB7, 57750T26, 57751T26, 57752RB6, 57753RB6, 57754RB6, 57771RB6, 57772RB6, 57779RB6, 57783RB6, 57784RB6, 57785RB6, 57786T26, 57787T26, 57788RB6, 57789RB6, 57792T26, 57792T26, 57793RB6, 57807RB6, 57808RB6, 57824T26, 57824T26, 57824T27, 57825T26, 58819RB6, 588357Y, 58836RB6, 58837RB6, 58838RB6, 58839RB6, 588407Y, 588417Y, 588417Y, 58842RB6, 58843RB6, 58844RB6, 58877RB6, 58878RB6, 58879RB6, 58880RB6, 58881T26, 58882T26, 58883RB6, 58884T26, 58885RB6, 58886T26, 58887RB6, 58888RB6, 58889RB7, 58890RB6, 58891RB6, 58912RB6, 58913RB6, 58914RB6, 58915T26, 58916T26, 58917T26, 58918T26, 58919T26, 58920RB6, 58921RB6, 58922RB6, 58923RB6, 58924RB6, 58925RB6, 58926T26, 58927RB6, 58928RB6, 58929T26, 58930RB6, 58948RB6, 58949T26, 58950RB6, 58951RB6, 58952T26, 58954T26, 59050RB6, 59051RB6, 59052RB6, 59053RB6, 59054T26, 59055RB6, 59056T26, 59057RB6, 59059RB6, 59060T26, 59061RB6, 590627Y, 59091RB6, 59092RB6, 59093RB6, 59095RB6, 59096RB6, 590977Y, 59098RB6, 59099RB6, 591007Y, 59101RB6, 59102RB6, 59103RB6, 59104RB6, 59105RB6, 59106RB6, 59107RB6, 59953T26, 59979RB6, 59980T26, 59981T26, 599827Y, 599827Y, 599837Y, 599847Y, 59985T26, 59986RB6, 59986RB7, 59987RB6, 59988RB6, 59989T26, 59990T26, 599917Y, 599917Y, 60135T26, 60135T26, 60136T26, 60137RB6, 60138T26, 601397Y, 60140T26, 601417Y, 601427Y, 60143RB6, 60144RB6, 60145T26, 60146T26, 60147T26, 60149T26, 60158RB6, 60159RB6, 60160RB6, 60161RB6, 60162RB6, 60163T26, 60164RB6, 60165RB6, 60166T26, 60167RB6, 60168RB6, 60170RB6, 60173RB6, 60200RB6, 61169T26, 61171T26, 61172RB6, 61201RB6, 61202RB6, 61203RB6, 61204T26, 61205T26, 61235T26, 61236RB6, 61237RB6, 61238T26, 61239RB6, 61240T26, 61241RB6, 61242RB6, 61254RB6, 61255RB6, 61256RB6, 61257RB6, 61258RB6, 61259RB6, 61266RB6, 61278RB6, 61279RB6, 61280RB6, 61281T26, 61282T26, 61283RB6, 61284RB, 61285T26, 61286T26, 61287RB, 61288RB, 61307RB, 61308T26, 61309RB, 61310T26, 61311RB, 61312RB, 61313T26, 61314RB, 61315RB, 61316T26, 61317T26, 61318RB, 61319RB, 61320RB, 61321T27, 61322RB, 61322RB, 61323RB, 61340RB, 61341RB, 61342RB, 61343RB, 61344RB, 61345T26, 61346RB, 61347RB, 61348RB, 61350RB, 61351RB, 61352RB, 61353RB, 61354RB, 61355RB, 61356RB, 61376T26, 61377T26, 61377T26, 61378RB, 61379RB, 61380RB, 61381T26, 61382RB, 61383T26, 61384T26, 61385RB, 61386RB, 61387T26, 61387T26, 61388RB, 61389RB, 61390T26, 61390T26, 62409RB, 62410RB, 62411T26, 62411T27, 62412RB, 62412RB1, 62413RB, 62414T26, 62414T27, 624157Y, 624157Y, 624157Y, 624157Y, 624157Y, 624157Y, 62416RB, 624177Y, 624177Y, 624177Y, 624177Y, 624177Y, 62418RB, 62419RB, 62419RB1, 62420T26, 62421RB, 62422RB, 62423RB, 62444RB, 62445RB6, 62452RB6, 62453T26, 62454RB6, 62455T26, 62456RB6, 62457T26, 62458T26, 62459T26, 62460T26, 62461T26, 62462T26, 62463T26, 62464T26, 62465T26, 62504RB6, 62505RB6, 62506RB6, 62507RB6, 62508RB6, 62509RB6, 62518RB6, 62520RB6, 62520RB7, 62521RB6, 62522T26, 62523T26, 62523T26, 62523T27, 62523T27, 62524RB6, 62525RB6, 62526RB6, 62527T26, 62528RB6, 62529RB6, 62529RB7, 62530RB6, 62531T26, 62532RB6, 62533RB6, 62534T26, 62535RB6, 63560T26, 63561T26, 63562RB6, 63563T26, 63564RB6, 63565T26, 63566RB6, 63567RB6, 63568T26, 63569T26, 63570T26, 63571RB6, 63572RB6, 63573RB6, 63574RB6, 63575RB6, 63576T26, 63603T26, 63604RB6, 63605RB6, 63606T26, 63607RB6, 63608T26, 63609RB6, 63610RB6, 63611T26, 63612RB6, 63613RB6, 63614T26, 63615RB6, 63616RB6, 63617T26, 63618RB6, 63619T26, 63650RB6, 63651T26, 63652RB6, 63653RB6, 63654RB6, 63655T26, 63656RB6, 63656RB6, 63657RB6, 63658T26, 63659RB6, 63660T26, 63685RB6, 63686RB6, 63687RB6, 63688RB6, 63689T26, 63690RB6, 63691RB6, 63692T26, 63693RB6, 63694RB6, 63695T26, 63696RB6, 63697RB6, 63698RB6, 63700RB6, 63700RB7, 63701RB6, 63702RB6, 64724RB6, 64725RB6, 64726RB6, 64727RB6, 647287Y, 647287Y10, 64729RB6, 647307Y, 64731RB6, 64732RB6, 64733RB6, 64734RB6, 64735RB6, 64736RB6, 64737RB6, 64738RB6, 64771RB6, 64772RB6, 64773RB6, 647747Y, 647747Y, 64775RB6, 64776RB6, 64777RB6, 647787Y, 647787Y, 64779RB6, 64780RB6, 64781RB6, 64782RB6, 64783RB6, 64785RB6, 64786T26, 64812RB6, 64813T26, 64814RB6, 648157Y, 64816RB6, 64817T26, 64818RB6, 64819T26, 64820RB6, 64821RB6, 64822RB6, 64823RB6, 64824RB6, 64825RB6, 64826RB6, 64845RB6, 64846RB6, 64847RB6, 64848RB6, 64849RB6, 64850RB6, 64851RB6, 64852RB6, 64853RB6, 64854RB6, 64855RB6, 64856RB6, 64857RB6, 64858RB6, 64859RB6, 64860RB6, 64861RB6, 64862RB6, 64863RB6, 65057RB6, 65058RB6, 65059RB6, 65060RB6, 65061RB6, 65062RB6, 65063RB6, 65064RB6, 65864RB6, 65865RB6, 65866RB6, 65867RB6, 65959RB6, 65960RB6, 65960RB7, 65961RB6, 65961RB7, 65962RB6, 65963RB6, 65964RB6, 65966RB6, 66065RB6, 66066RB6, 66067RB6, 66068RB6, 66069RB6, 66070RB6, 66071RB6, 66072RB6, 66073RB6, 66074RB6, 66075RB6, 66076RB6, 66077RB6, 66078RB6, 66079RB6, 6079RB6, 66080RB6, 66081RB6, 66114RB6, 66115RB6, 66116RB6, 66117RB6, 66117RB7, 66118RB6, 66119RB6, 66120RB6, 66121RB7, 66122RB6, 66123RB6, 66124RB6, 66125RB6, 66126RB6, 66127RB6, 66128RB6, 66129RB6, 66151RB6, 66152RB6, 66153RB6, 66154RB6, 66180RB6, 661817Y, 66182RB6, 66183RB6, 66183RB6, 66184RB6, 66214RB6, 662157Y, 6216RB6, 66217RB6, 662187Y, 66219RB6, 662207Y, 66221RB6, 66222RB6, 66223RB6, 66224RB6, 67266RB6, 67267RB6, 67268RB6, 67269RB6, 67286RB6, 67288RB6, 67289RB6, 67290RB6, 67291RB6, 67292RB6, 67293RB6, 67294RB6, 67297RB6, 67297T26, 67298RB6, 67298RB7, 67300RB6, 67301RB6, 67303RB6, 67304RB6, 67315RB6, 67320RB6, 67321RB6, 67401RB6, 67401T26, 67402RB6, 68420RB6, 68424RB6, 68464RB6, 68465RB6, 68465RB7, 68507RB6, 68508RB6, 68517RB6, 68518RB6, 68519RB6, 68520RB6, 68568RB6, 68569RB6, 68572RB6, 68596RB6, 68601RB6, 68602RB6, 68603RB6, 68604RB6, 68614RB6, 68617RB6, 68621RB6, 68622RB6, 68627RB6, 68697RB, 68698RB, 68701RB6, 68701RB6, 68702RB6, 68703RB6, 68709RB6, 69640RB, 69764RB, 69765RB, 69766RB, 69771RB, 69783RB, 69799RB, 69815RB, 69816RB, 70004RB, 70005RB, 70008RB, 70009RB, 70010RB, 70011RB, 70012RB, 70013RB, 70013RB, 70014RB, 70014RB, 70014RB1, 70016RB, 70017RB, 70038RB, 70039RB, 70040RB, 70041RB, 70047RB, 70048RB, 70049RB, 70050RB, 70051RB, 70052RB, 70096RB, 70833RB, 70835RB6, 70836RB6, 70846RB6, 70925RB, 709287Y, 70935RB, 70936RB, 70937RB, 70938RB, 70938RB, 70938RB, 70943RB, 70960RB, 70965RB, 70966RB, 70967RB, 71075RB, 71076RB, 71077RB, 71082RB, 71083RB, 71084RB, 71085RB, 71086RB, 71087RB, 71140RB, 71141RB, 71144RB, 71176RB, 71177RB, 71178RB, 71180RB, 71181RB, 71232RB, 71233RB, 72234RB, 72235RB, 72236RB, 72237RB, 72238RB, 72239RB, 72239RB1, 72257RB, 72258RB, 72303RB, 72304RB, 72305RB, 72306RB, 72307RB, 72308RB, 72315RB, 72316RB, 72332RB, 73422RB, 73425RB, 73428RB, 73429RB, 73430RB, 73433RB, 73434RB, 73435RB, 73436RB, 73439RB, 73440RB, 73441RB, 73472RB, 73473RB, 73474RB, 73474RB, 73475RB, 73476RB, 73480RB, 73481RB, 73481RB, 73481RB, 73483RB, 73483RB, 73484RB, 73487RB, 73488RB, 73581RB, 73582RB, 73583RB, 73584RB, 73585RB, 73586RB, 73589RB, 74608RB, 74609RB, 74610RB, 74652RB, 74710RB, 74745RB, 74746RB, 74747RB, 75795T2, 75796RB, 75797RB, 75798RB, 75828T2, 75828T2, 75914T2, & 75915T2;
10) Lot #'s: 75785T2, 75786RB, 75786T2, 75875T2, 75875T2, 75876T2, 75902RB, 75902RB, 75902T2, 76021T2, 76065T2, 76065T2, 77081T2, 78209T2, 78210T2, 80641T2, 80642T2, 83084T2, 83085T2, 84310T2, 84311T2, 85482T2, 85483T2, 87878T21, 87879T21, 87879T21, 88010T20, 88010T20, 88030T20, 91551T20, 91551T21, 91551T21, 91552T20, 92617T20 & 92618T20;
11) Lot #’s: 87842T20, 87842T26, 87931T20, 87932T20, 87932T20, 87933T20, 87964T20, 87964T21, 87965T20, 88044T20, 88045T20, 88046T20, 88104T20, 88105T20, 88117T20, 88117T26, 88118T20, 88119T20, 88120T20, 89227T20, 89227T26, 89227T26, 89230T20, 89231T20, 89231T20, 89231T20, 89231T21, 89232T20, 89232T20, 89258T20, 89259T20, 89260T20, 89310T20, 89311T20, 89312T20, 90333T20, 90333T26, 90333T26, 90336T20, 90336T20, 90337T20, 90338T20, 90366T20, 90366T26, 90367T20, 90367T26, 90370T20, 90371T20, 90372T20, 90373T20, 91434T20, 91435T20, 91435T26, 91455T20, 91479T20, 91480T20, 91481T20, 91490T20, 91491T20, 91492T20, 91493T20, 91494T20, 91542T20, 92654T20, 92655T20, 92656T20, 92659T20, 92660T20, 92661T20, 92670T20, & 92670T20;
12) Lot #’s: 77001T2, 77160T2, 77160T2, 77169T2, 79494T2, 79495T2, 79496T2, 82870T2, 82871T2, 82872T2, 84262T2, 85260T2, 85261T2, 87829T20, 87830T20, 7927T20, 90382T20, & 90403T20;
13) Lot #’s: 75789T2, 75790T2, 75837T2, 75837T2, 75838T2, 75882T21, 75916T2, 76019T2, 76020T2, 76034T2, 76049T21, 76049T22, 76050T2, 77083T2, 77084T2, 77165T2, 77166T2, 77167T2, 77168T2, 78177T2, 78234T2, 78235T2, 78299T2, 78300T2, 78301T2, 78301T2, 78302T2, 78316T2, 78317T2, 79374T2, 79375T2, 79381T2, 79382T2, 79383T2, 79417T2, 79461T2, 79517T2, 80623T2, 80624T2, 80625T2, 80626T2, 80638T2, 80639T2, 80640T2, 81783T2, 81803T2, 81805T21, 82868T2, 82875T2, 82876T2, 83096T2, 83097T2, 83098T2, 83228T2, 83229T2, 83230T2, 83231T2, 83232T2, 84278T2, 85409T2, 85410T2, 85411T2, 85466T2, 85467T2, 85468T2, 85469T2, 85527T2, 85527T2, 85527T2, 85528T2, 85528T2, 85528T2, 85529T2, 85529T2, 85530T2, 85530T2, 86713T20, 86714T20, 86715T20, 86716T20, 87843T20, 87844T20, 87845T20, 75917T2, 76035T2, 78178T2, 79462T2, 80637T2, 81804T2, 83099T2, 84279T2, 85531T2, 88064T20, 75882T2, 76064T2, 78208T2, 78208T2, 78208T2, 82877T2, 82877T21 & 82996T2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Nutrition, Abbott Laboratories, Columbus, OH, by press release on September 22, 2010 and September 23 2010, by letter on September 22 & 27, 2010 and by e-mail.
Manufacturer: Abbott Laboratories, Inc., Sturgis, MI. Firm initiated recall is ongoing.
REASON
Abbott is recalling these products following an internal quality review, which detected the presence of a small common beetle in the product.
VOLUME OF PRODUCT IN COMMERCE
113,361,078 individual units
DISTRIBUTION
Nationwide and American Samoa, Armenia, Antigua, Aruba, Bahamas, Barbados, Bermuda, Curacao, Grand Cayman, Grenada, Guam, Guyana, Haiti, Jamaica, Puerto Rico, Saipan, Saudi Arabia, St. Croix, St. Lucia, St. Martens, St. Thomas, St. Vincent, Tanzania, Tortola, Trinidad, Turks and Caico Island
___________________________________
PRODUCT
1) Pecan Delights Tin, Net Weight 10 oz (283 g), Item #09-168. Recall # F-0025-2011;
2) Milk Chocolate Pecan Perk, Net Weight - 23 lb, Item #05-620. Recall # F-0026-2011
CODE
1) Product Code L0121D-158488;
2) Product Code F0122E-158319
RECALLING FIRM/MANUFACTURER
Zachary Confections, Inc., Frankfort, IN, by telephone August 12, 2010. Firm initiated recall is complete.
REASON
Finished product tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
222 (23 lb each) boxes; 40 cases of 24 (10 oz) tins
DISTRIBUTION
PA, OH
___________________________________
PRODUCT
Champion Nutrition, Pure Whey, Protein Stack, Chocolate Peanut Butter, 22g of Protein, Per Serving, No Aspartame, No Fillers, Low-Lactose, Low-Carb, Mixes Instantly!, No Blender Required, Dietary Supplement, Net Wt. 5 lbs (2.27 kg), 71 Servings!, 22g of Protein per Serving, (UPC) 027692185501. Recall # F-0027-2011
CODE
Lot Number: C9288A (exp. date 03/2011), G9201A (exp. date 07/2011), L9282A (exp. date 01/2012), A0210A (03/2012), D0329A (exp date 04/2012)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Champion Nutrition, Fort Lauderdale, FL, by letter, press release and website posting’s beginning June 29, 2010.
Manufacturer: Nature’s Products, Inc., Sunrise, FL. Firm initiated recall is ongoing.
REASON
Product contains peanuts which are not declared as an ingredient on the ingredient panel.
VOLUME OF PRODUCT IN COMMERCE
10,605
DISTRIBUTION
Nationwide, Japan, Slovenia, UK, Lebanon, Indonesia, Belgium, Italy, Malaysia, Dominican Republic, Czech Republic, Cyprus, Peru, Singapore, Canada, Grenada, Malta, and Chile
___________________________________
PRODUCT
1) Italian Almonds, chocolate coated almonds with amaretto flavoring, 3 oz., in gold pouch container with red label, UPC 64482300177. Recall # F-0028-2011;
2) Assorted chocolate cremes, 8 oz and 12 oz., in gold box with brown label, UPC 4482301225 and 4482312301. Recall # F-0029-2011
CODE
None
RECALLING FIRM/MANUFACTURER
The South Bend Chocolate Co., Inc., South Bend, IN, by letters on August 26, 2010. Firm initiated recall is ongoing.
REASON
Italian almonds contain almonds that are not declared on the product label. Assorted cremes contain FD&C # 5 and 6 that are not declared on the product label.
VOLUME OF PRODUCT IN COMMERCE
849 products
DISTRIBUTION
MI, IL, IN, OH, NJ, NY, TX, FL
___________________________________
PRODUCT
V & S Large Lobster Ravioli; Net Weight 5 lbs. (2.27 kg); frozen pasta in bulk polylined box. Recall # F-030-2011
CODE
Production codes: 80210, 82410, 82710 and 90710
RECALLING FIRM/MANUFACTURER
Vince & Sons Pasta Co., Bridgeview, IL, by letters on September 21, 2010. FDA initiated recall is ongoing.
REASON
The Large Lobster Ravioli contain hydrolyzed corn/soy/wheat protein, which was not declared in the ingredients statement, and there was no allergen statement.
VOLUME OF PRODUCT IN COMMERCE
441 boxes
DISTRIBUTION
CO, GA, IL, IN, MI, MN, MO, NY, OR, WI, WY
___________________________________
PRODUCT
Nature Valley Granola Thins Dark Chocolate, 10 1-square pouches, Net Wt. 6 oz (170g). UPC 16000-41888, Ingredients. Contains, Soy, Milk, May contain egg, peanut, walnut and wheat ingredients. Recall # F-0031-2011
CODE
Better if used by 05JUN2011 YO 12
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Mills, Inc., Minneapolis, MN, by press release, e-mail and telephone on September 22, 2010.
Manufacturer: Hearthside Food Solutions - H12, London, KY. Firm initiated recall is ongoing.
REASON
Individually wrapped and labeled Nature Valley Granola Peanut Butter Thins was placed in Nature Valley Granola Dark Chocolate Thins consumer boxes.
VOLUME OF PRODUCT IN COMMERCE
1,440 cases (17,280 consumer units)
DISTRIBUTION
AL, AR, CO, GA, IA, IL, IN, KS, KY, LA, MN, MO,MS, NC, OH, PA, SC, TN, VA, WY
_____________________________________
PRODUCT
Kidsmania Flash Pop: Three Brilliant Flavors (Artificially Flavored) New Enhanced flavors - Radiant Strawberry; Beaming Blue Raspberry and Glowing Watermelon. Product is packaged in display cardboard container (Black, white, blue, red, yellow and pink) which includes four cylindrical 1.19 oz units of each: Radiant Strawberry (plastic cylindrical container is pink and label is: pink, yellow, blue black & white printed on colorful metallic wrap.); Beaming Blue Raspberry (plastic cylindrical container is Blue and package is: blue, black, white yellow, red and pink printed on colorful metallic wrap.) and Glowing Watermelon (plastic cylindrical container is yellow/green and package is: yellow, black, white, green, red and pink printed on colorful metallic wrap.) There are 12 units candy in each display container and each unit is 1.19 oz. Item # C455 in firms catalogue. UPC Code on master carton: 686464455701. UPC Code on display case: 686464455206. UPC Code on Retail/Individual Unit: 686464455008. Recall # F-0054-2011
CODE
Lot Codes: 090824A & 090910A
FIRM/MANUFACTURER
Recalling Firm: Kidsmania, Inc., Santa Fe Springs, CA, by press release and letters beginning June 28, 2010.
Manufacturer: Zhaoqing Kidstar Toys Manufactory Limited, Zhaoqing, China. California initiated recall is ongoing.
REASON
Product contains elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
Firm does not track distribution by lot number. Recalling based on product self life of 1.5yrs. Will recall back from when firm was notified.
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bunge Old World Classic Unsalted Butter Blend, packaged in unlabeled 1-lb. blocks wrapped in parchment paper, 30 blocks/case. The firm name on the case label is Bunge. Recall # F-0059-2011
CODE
Lot # 0245012220
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bunge Oils, Inc., Saint Louis, MO, by telephone on September 13, 2010.
Manufacturer: Bunge Oils – Kearny, Kearny, NJ. Firm initiated recall is ongoing.
REASON
E. coli, coliforms and fecal coliforms found in a routine sample of product.
VOLUME OF PRODUCT IN COMMERCE
70/30/1-lb. package cases
DISTRIBUTION
PA
___________________________________
PRODUCT
1) 1000 Island Dressing - Gelson's The Super Market. Recall # F-0060-2011
2) Ranch Dressing - Gelson's The Super Market. Recall # F-0061-2011;
3) Nickabood's Fisherman's Wharf Horseradish Sauce 8 Fl. oz. - UPC 070426000168.
Recall # F-0062-2011
CODE
1) PRODUCT CODE: 30603 MFG. ON: 04/0810, 05/19/10, 07/26/10, 08/23/10;
2) MFG. ON: 04/2310, 05/20/10, 06/03/10, 06/22/10, 08/05/10, 08/16/10;
3) BEST USED BY: 042411 on immediate container; BEST USED BY: 04/23/11 on shipping box
RECALLING FIRM/MANUFACTURER
Nickaboods, Inc., Los Angeles, CA, by telephone, mail/e-mail and visit on September 7, 2010. Firm initiated recall is ongoing.
REASON
Nickaboods, Inc initiated this recall after it learned that it failed to list anchovies on its product labels after a change to a bulk ingredient containing anchovies used to make its products.
VOLUME OF PRODUCT IN COMMERCE
123 cases - 1000 Island Dressing; 180 cases - Ranch Dressing; 34 cases - Horseradish Sauce
DISTRIBUTION
CA
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Bumetanide Injection, USP, 0.5 mg/2 mL (0.25 mg/mL), 2 mL Vial (NDC 10019-506-39), packaged in 10 x 2 mL vials per carton (NDC 10019-506-02), Rx only. Recall # D-011-2011;
2) Bumetanide Injection, USP, 1 mg/4 mL (0.25 mg/mL), 4 mL Vial, NDC 10019-506-37, packaged in 10 x 4 mL vials per carton, NDC 10019-506-45, Rx only. Recall # D-012-2011;
3) Bumetanide Injection, USP, 0.25 mg/mL, 10 mL Multiple Dose Vial, NDC 10019-506-36, packaged in 10 x 10 mL Multiple Dose Vials per carton, NDC 10019-506-10, Rx only. Recall # D-013-2011
CODE
1) Lot # 07L108, Exp 09/10;
2) Lot #: 07J119, Exp 08/10; 07L115, Exp 09/10; 07P129, Exp 11/10; 31301347B, Exp 03/11; and 31302833B, Exp 07/11;
3) Lot #: 07K116, Exp 08/10; 07N110, Exp 10/10; 08A116, Exp 01/11; 31300744B, Exp 02/11; 31301719B, Exp 04/11; 31303191B, 31303192B, Exp 07/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on August 11, 2010.
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Particulate matter was found in lots of retain samples.
VOLUME OF PRODUCT IN COMMERCE
1,790,770 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cancidas (Caspofungin acetate) for Injection, for Intravenous Use, 50 mg, NDC 0006-3822-10. Recall # D-014-2011
CODE
Lot 1553Y exp 6/30/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merck Sharp & Dohme, West Point, PA, by letter June 7, 2010.
Manufacturer: Merck & Company, Inc., West Point, PA. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility (cracked vials).
VOLUME OF PRODUCT IN COMMERCE
482 vials
DISTRIBUTION
CT, IL, MO, NY, TN, MA, OK, OH, FL, MI, PA, KY
___________________________________
PRODUCT
Dronabinol 2.5mg Capsules, USP, Liquid filled gelatin capsule, Carton NDC #68084-174-01, Dose NDC #68084-174-11. Recall # D-015-2011
CODE
Lot # 103869B, Exp. 06/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by e-mails and letters on September 17, 2010.
Manufacturer: Pharmaceutics International Inc., Hunt Valley, MD. Firm initiated recall is ongoing.
REASON
Temperature abuse: The affected product was stored below freezing conditions for 10-12 hrs. Liquid filled gelatin capsules that are subjected to conditions below freezing have an increased possibility of leaking due to the gelatin becoming brittle or the volume of the liquid inside shrinking and expanding.
VOLUME OF PRODUCT IN COMMERCE
180 units/100/2.5 mg capsules
DISTRIBUTION
AZ, CA, IL, MO, NC, NJ, PA, TN, TX
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Claravis (isotretinoin capsules, USP), 40 mg, packaged in cartons containing 3 blister packs of 10 capsules each (30 capsules), Rx only, NDC 0555-1057-86. Recall # D-016-2011
CODE
Lot #701980, Exp 01/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by e-mail and letter of September 21, 2010.
Manufacturer: Barr Laboratories, Inc., Pomona, NY. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: 18 month stability testing revealed that the product may dissolve slower than intended.
VOLUME OF PRODUCT IN COMMERCE
11,128 cartons
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Panoscreen I, II and III, packated 3 X 10 mL vials. Recall # B-2375-10
CODE
Lot No. 24223, expiration date August 20, 2010
RECALLING FIRM/MANUFACTURER
Immucor Inc., Norcross, GA, by e-mail and letter on July 16, 2010. Firm initiated recall is complete.
REASON
Immucor Panoscreen III, which does not include an S positive donor cell, was distributed.
VOLUME OF PRODUCT IN COMMERCE
224 units
DISTRIBUTION
CA, CT, FL, IL, PA, Canada & Germany
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2405-10
CODE
Unit: 1490714
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on June 9, 2010, and by letters dated June 10, 2010 and July 12, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, MN
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2406-10;
2) Platelets. Recall # B-2407-10
CODE
1) and 2) Unit: 9583807
RECALLING FIRM/MANUFACTURER
Cart`er BloodCare, Bedford, TX, by telephone on August 19, 2008 and by letter dated August 28, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2408-10;
2) Platelets. Recall # B-2409-10;
3) Red Blood Cells. Recall # B-2411-10;
4) Fresh Frozen Plasma. Recall # B-2412-10
CODE
1) Unit: 1240297;
2) Unit: 1102034
3) Units: 1102034, 1305230, 1359491, 1437984, 0942580, 0896223;
4) Units: 1102034, 0942580, 1305230, 1437984
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on June 15, 2010, and by letters dated June 22, 2010 and August 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Switzerland, VT, VA, MN, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2413-10
CODE
Unit: 22GT39817
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on May 28, 2010 and by letter dated May 28, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ, CA
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-2415-10;
2) Red Blood Cells. Recall # B-2416-10
CODE
1) and 2) Unit: 01GQ44568
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, West Henrietta, NY, by telephone and facsimile on June 9, 2010 and by letters dated June 9, 2010 and June 10, 2010.
Manufacturer: The American National Red Cross, Albany, NY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received an accidental needle stick, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # 2417-10
CODE
Units: W036510053301 (2units)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on June 28, 2010. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # 2418-10
CODE
Unit: 72P108174
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Birmingham Region, Birmingham, AL, by facsimile on July 3, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2486-10
CODE
Units: 72P132531, 72N392104
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL, by telephone on July 19, 2010. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2487-10
CODE
Unit: 72P370281
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Dunwoody, GA, by fax on July 29, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2488-10
CODE
Unit: W043210044103
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on July 7, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2490-10
CODE
Unit: 6377200
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter on June 14, 2010 and by e-mail on June 15, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously permanently deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, FL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2493-10
CODE
Unit: W12701081553400
RECALLING FIRM/MANUFACTURER
Recalling Firm: Southeastern Community Blood Center, Tallahassee, FL, by fax on July 21, 2010.
Manufacturer: Florida Blood Services, Inc., Marianna, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2509-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-2510-10
CODE
1) and 2) Unit: W088610102031
RECALLING FIRM/MANUFACTURER
Providence Health System, Southern California, Burbank, CA, by letter on July 19, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2517-10
CODE
Units: 1386351, 1325195, 0883865
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on June 30, 2010 and by letter dated July 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2518-10
CODE
Unit: W165710016327E
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital Inc., Attn Blood Bank, Baton Rouge, LA, by telephone on July 19, 2010 and by facsimile on July 20, 2010. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # Recall # B-2519-10
CODE
Unit: 5423408
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Ocala, FL, by telephone on September 18, 2009 and letter dated September 18, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-2521-10;
2) Red Blood Cells Leukocytes Reduced. Recall # Recall # B-2522-10
CODE
1) and 2) Unit: 21LX00603
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by facsimile on June 30, 2010. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-2523-10;
2) Plasma. Recall # B-2524-10;
3) Red Blood Cells. Recall # B-2525-10;
4) Fresh Frozen Plasma. Recall # B-2526-10
CODE
1) Unit: W038508310277;
2) Units: 3127765, W038508310277, 3129157, 4121927;
3) Units: W038508310277, 3129157, 3127765, 4025397, 4121927, 4018030;
4) Units: 4025397, 4018030
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on July 22, 2010 and July 28, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
GA, MD, SC, Austria, Israel, South Korea, Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2527-10
CODE
Unit: 17LM08745
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by electronic notification on April 25, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information regarding the donor’s receipt of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2528-10
CODE
Unit: W120610282034
RECALLING FIRM/MANUFACTURER
Michigan Blood Bank, Saginaw, MI, by facsimile on July 20, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2529-10
CODE
Unit: W120610270540
RECALLING FIRM/MANUFACTURER
Michigan Blood Bank, Saginaw, MI, by facsimile on July 15, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who resided in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2530-10
CODE
Units: W141610004884AO, W141610004884BO
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated August 3, 2010.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-2531-10;
2) Recovered Plasma. Recall # B-2532-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-2533-10
CODE
1) Unit: W115910041730;
2) Units: W115910080008, W115910081199;
3) Units: W115910080008, W115910041730, W115910081199
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on July 19, 2010 and July 23, 2010 and by facsimile on July 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Austria, CA
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets. Recall # B-2331-10
CODE
Unit: W035208157944M
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated October 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2404-10
CODE
Unit: 1490714
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on June 9, 2010, and by letters dated June 10, 2010 and July 12, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, MN
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2410-10
CODE
Units: 1240297, 0942580, 0896223
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on June 15, 2010, and by letters dated June 22, 2010 and August 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, VT, VA, MN, IL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2414-10
CODE
Unit: 22GT39817
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on May 28, 2010 and by letter dated May 28, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ, CA
___________________________________
PRODUCT
Red Blood Cells. Recall # 2489-10
CODE
Unit: W127810302567
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone and letter on July 7, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had no hemoglobin check recorded during screening, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2491-10
CODE
Unit: 6377200
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter on June 14, 2010 and by e-mail on June 15, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously permanently deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2492-10
CODE
Unit: W12701081553400
RECALLING FIRM/MANUFACTURER
Recalling Firm: Southeastern Community Blood Center, Tallahassee, FL, by fax on July 21, 2010.
Manufacturer: Florida Blood Services, Inc., Marianna, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2516-10
CODE
Units: 1386351, 1325195, 0883865
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on June 30, 2010 and by letter dated July 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2520-10
CODE
Units: W125610009183, W125610009197
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by telephone on July 19, 2010. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane. The Monoplane system has one C-arm and it could be mounted on a ceiling or on the floor stand. Recall # Z-2448-2010;
2) BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the ceiling. Recall # Z-2449-2010
CODE
1) Each unit is identified with a SITE number: 38358, 101952, 102560, 102564, 102730, 102923, 102948, 103128, 103265, 103275, 103289, 103331, 103380, 103525, 103561, 103562, 103564, 103696, 103729, 103751, 103780, 103781, 103927, 104060, 104075, 104106, 104139, 104149, 104464, 104501, 104512, 104514, 104515, 104536, 104642, 104668, 104670, 104890, 104925, 104927, 104952, 104954, 104955, 104956, 104957, 104958, 105073, 105081, 105082, 105100, 105136, 105137, 105139, 105140, 105153, 105156, 105157, 105186, 105191, 105304, 105343, 105386, 105390, 105402, 105409, 105583, 105598, 105615, 105631, 105655, 105656, 105670, 105674, 105684, 105686, 105742, 105779, 105784, 105866, 105908, 105912, 105917, 105940, 105946, 105947, 105950, 105951, 105952, 105953, 105961, 500004, 500028, 500029, 500038, 500041, 500042, 500052, 504344, 504493, 504636, 504638, 504646, 504659, 504665, 504666, 504730, 504747, 504750, 504769, 504770, 504776, 504789, 504792, 504795, 504797, 504798, 504806, 504807, 504871, 504872, 504903, 504904, 504908, 504913, 504915, 504916, 504920, 504940, 504977, 504988, 505008, 505017, 505064, 505106, 505107, 505111, 505135, 505250, 505252, 505254, 505270, 505271, 505281, 505363, 505421, 505424, 505486, 505520, 505538, 505546, 505572, 505587, 505650, 505651, 505668, 505679, 505680, 505706, 505719, 505759, 505803, 505804, 505805, 505807, 505809, 505860, 505861, 505886, 505925, 505968, 505989, 506009, 506047, 506048, 506049, 506060, 506121, 506148, 506169, 506170, 506178, 506222, 506225, 506230, 506232, 506322, 506369, 506370, 506397, 506403, 506408, 506462, 506469, 506476, 506538, 506539, 506540, 506541, 506564, 506616, 506621, 506637, 506654, 506657, 506658, 506693, 506778, 506785, 519115, 519179, 519195, 519198, 519199, 519211, 519212, 519213, 519214, 519533, 519534, 519535, 519536, 519537, 519541, 519548, 519576, 519594, 519673, 519676, 519677, 519680, 519733, 519738, 519767, 519771, 519812, 519874, 519894, 519899, 519901, 520004, 520147, 520189, 520236, 520251, 520309, 520319, 520430, 520431, 520481, 520491, 520517, 520523, 520524, 520525, 520526, 520598, 520630, 520631, 520632, 520660, 520680, 520681, 520755, 520761, 520779, 520783, 520809, 520814, 520840, 520882, 520948, 520956, 520977, 521001, 521131, 521154, 521222, 521223, 521310, 521311, 521312, 521313, 521314, 521315, 521318, 521320, 521463, 521512, 521537, 521545, 521548, 521562, 521589, 521650, 521659, 521661, 521675, 521711, 521763, 521769, 521770, 521802, 521820, 521853, 521854, 521890, 521892, 521918, 522038, 522065, 522118, 522119, 522135, 522138, 522162, 522177, 522191, 522224, 522243, 522245, 522247, 522250, 522293, 522397, 522418, 522440, 522446, 522458, 530361, 530368, 530370, 530390, 530391, 530392, 530393, 530421, 530459, 530460, 530463, 530464, 530466, 530485, 530584, 530655, 530656, 530658, 530662, 530663, 530664, 530666, 530667, 530668, 530669, 530715, 530783, 531651, 531728, 531752, 531753, 531760, 531762, 531805, 531806, 531808, 531813, 531817, 531834, 531837, 531931, 531942, 531943, 531944, 531945, 531946, 531948, 531949, 531951, 531957, 531961, 532074, 532077, 532080, 532148, 532150, 532172, 532178, 532207, 532215, 532225, 532226, 532227, 532234, 532235, 532239, 532244, 532245, 532246, 532249, 532262, 532263, 532264, 532292, 532294, 532445, 532446, 532532, 532533, 532534, 532535, 532611, 532612, 532613, 532615, 532616, 532617, 532649, 532652, 532799, 532800, 532986, 532990, 533084, 533085, 533236, 533278, 533282, 533283, 533284, 533285, 533286, 533287, 533289, 533325, 533343, 533394, 533395, 533398, 533401, 533418, 533476, 533541, 533543, 533551, 533567, 533619, 533738, 533762, 533763, 533772, 533796, 533857, 533861, 533897, 533922, 533955, 533956, 533966, 533967, 534108, 534150, 534152, 534155, 534158, 534159, 534160, 534215, 534217, 534218, 534221, 534232, 534233, 534237, 534246, 534250, 534251, 534252, 534255, 534268, 534270, 534374, 534380, 534418, 534420, 534427, 534431, 534440, 534452, 534476, 534477, 534478, 534479, 534545, 534565, 534569, 534627, 534630, 534634, 534638, 534639, 534646, 534665, 534678, 534681, 534682, 534716, 534717, 534720, 534724, 534730, 534731, 534743, 534758, 534787, 534796, 534798, 534811, 534813, 534856, 534874, 534876, 534879, 534927, 534928, 534941, 535094, 535151, 535152, 535173, 535212, 535213, 535224, 535250, 535274, 535278, 535285, 535303, 535326, 535342, 535348, 535367, 535376, 535387, 535396, 535400, 535415, 535416, 535418, 535424, 535439, 535492, 535566, 535611, 535614, 535615, 535635, 535667, 535702, 535727, 535728, 535769, 535772, 535777, 535779, 535793, 535813, 535814, 535927, 535931, 535946, 535951, 535979, 535982, 536006, 536007, 536014, 536030, 536067, 536090, 536136, 536138, 536154, 536155, 536163, 536173, 536174, 536178, 536234, 536379, 536425, 536433, 536471, 536592, 536639, 536641, 536646, 536714, 536717, 536721, 536736, 536777, 536796, 536798, 536801, 536901, 536921, 536954, 536966, 536993, 537020, 537024, 537065, 537073, 537118, 537205, 537266, 537268, 537296, 537357, 537386, 537466, 537514, 537588, 537589, 537590, 537597, 537604, 537630, 537644, 537698, 537717, 537731, 537743, 537745, 537784, 537805, 537810, 537838, 537854, 537855, 537922, 537934, 537935, 537937, 537938, 537985, 538084, 538102, 538193, 538194, 538228, 538234, 538269, 538322, 538368, 538369, 538386, 538404, 538406, 538416, 538432, 538449, 538464, 538465, 538466, 538476, 538479, 538482, 538485, 538486, 538512, 538537, 538538, 538744, 538771, 538806, 538813, 538902, 538903, 538910, 538911, 539094, 539099, 539107, 539204, 539220, 539224, 539267, 539268, 539322, 539323, 539369, 539380, 539381, 539398, 539455, 539456, 539472, 539479, 539480, 539516, 539595, 539634, 539641, 539745, 540048, 540070, 540082, 540150, 540167, 540203, 540209, 540213, 540234, 540235, 540269, 540275, 540284, 540288, 540301, 540311, 540312, 540321, 540325, 540338, 540374, 540386, 540421, 540456, 540460, 540468, 540487, 540488, 540622, 540684, 540790, 540808, 540841, 540887, 540912, 540930, 540952, 540973, 541026, 541029, 541030, 541046, 541047, 541049, 541053, 541080, 541223, 541251, 541253, 541259, 541409, 541509, 541510, 541572, 541588, 541592, 541597, 541657, 541659, 541667, 541715, 541742, 541748, 541783, 541822, 541848, 541873, 541880, 542109, 542113, 542117, 542306, 542478, 542486, 542518, 542522, 542526, 542744, 543087, 543108, 543194, 543198, 543209, 543213, 543216, 543229, 543386, 543397, 543398, 543399, 543408, 543433, 543610, 543611, 543702, 543759, 543762, 543799, 543829, 543850, 543873, 543877, 543931, 543971, 543972, 543984, 543988, 543999, 544005, 544048, 544051, 544052, 544057, 544086, 544103, 544120, 544122, 544130, 544145, 544184, 544371, 544433, 544489, 544506, 544513, 544550, 544572, 544581, 544600, 544610, 544631, 544636, 544637, 544655, 544728, 544729, 544750, 544989, 544990, 544992, 545023, 545024, 545037, 545052, 545069, 545073, 545090, 545280, 545282, 545293, 545295, 545296, 545357, 545365, 545395, 545443, 545521, 545539, 545640, 545714, 545733, 545749, 545750, 545752, 545776, 545779, 545799, 545827, 545838, 545839, 545840, 545853, 545905, 545912, 545921, 545941, 545942, 545964, 545966, 545975, 545985, 545991, 546012, 546014, 546025, 546060, 546201, 546456, 546517, 546560, 546561, 546572, 546585, 546586, 546634, 546668, 546679, 546693, 546886, 546908, 546934, 547005, 547058, 547118, 547159, 547165, 547234, 547279, 547287, 547321, 547334, 547364, 547392, 547406, 547600, 547601, 547619, 547620, 547621, 547627, 547628, 547660, 547700, 547720, 547729, 547748, 547749, 547753, 547761, 547762, 547763, 547770, 547775, 547777, 547795, 547800, 547822, 547833, 547838, 547852, 547855, 547861, 547878, 547893, 547896, 547898, 547908, 547914, 547918, 547921, 547925, 547932, 547948, 547952, 547965, 547976, 547977, 548022, 548029, 548038, 548039, 548049, 548051, 548054, 548061, 548067, 548108, 548147, 548192, 548432, 548496, 548525, 548601, 548603, 548616, 548640, 548645, 548660, 548764, 548775, 548778, 548785, 548966, 549013, 549170, 549245, 549250, 549252, 549253, 549264, 549306, 549378, 549379, 549385, 549400, 549451, 549738, 549750, 549792, 549902, 549925, 549967, 550031, 550053, 550122, 550124, 550133, 550172, 550173, 550244, 550253, 550255, 550304, 550360, 550371, 550399, 550404, 550451, 551050, 551051, 551146,
551178, 551340, 551379, 551607, 551608, 551633, 551725, 551763, 551851, 551853, 552178, 552192, 552202, 552279, 552381, 552382, 552425, 552440, 552469, 552470, 552546, 552559, 552585, 552586, 552590, 552736, 553097, 553137, 553234, 553288, 553330, 553351, 553352, 553397, 553432, 553445, 553466, 553486, 553487, 553603, 553697, 553723, 553798, 553803, 553846, 553867, 553868, 553869, 553871, 553873, 553881, 553925, 553964, 553981, 553984, 554018, 554019, 554044, 554049, 554054, 554136, 554370, 554427, 554431, 554442, 554444, 554447, 554499, 554518, 554550, 554556, 554631, 554680, 554768, 554775, 554776, 554784, 554791, 554804, 554811, 554896, 555206, 555300, 555321, 555343, 555349, 555350, 555420, 555447, 555470, 555605, 555742, 555781, 555927, 556017, 556053, 556095, 556156, 556311, 556323, 556390, 556470, 556601, 556605, 556609, 556701, 556708, 556709, 556760, 556773, 556783, 556810, 556811, 556814, 556820, 556855, 556857, 556893, 557385, 557512, 557653, 558238, 558448, 558499, 558582, 560060, 41416356, 41416358, 41443581, 41443671, 41443700, 41443707, 41443774, 41443855, 41443882, 41443928, 41444385, 41444398, 41444399, 41444419, 41444446, 41444454, 41444461, 41444463, 41444558, 41444597, 41444603, 41444609, 41444646, 41444662, 41444680, 41444728, 41444743, 41444747, 41444753, 41444758, 41444791, 41444797, 41445001, 41445010, 41445014, 41445026, 41445032, 41445070, 41445119, 41445125, 41445169, 41445173, 41445202, 41445207, 41445229, 41445233, 41445235, 41445246, 41445250, 41445253, 41445254, 41445255, 41445256, 41445261, 41445270, 41445285, 41445303, 41445309, 41445310, 41445315, 41445332, 41445336, 41445344, 41445376, 41445377, 41445385, 41445390, 41445427, 41445434, 41445438, 41445452, 41445486, 41445495, 41445502, 41445514, 41445515, 41445516, 41445578, 41445582, 41445616, 41445645, 41445676, 41445677, 41445692, 41445701, 41445744, 41445766, 41445785, 41445804, 41445809, 41445816, 41445817, 41445875, 41445916, 41445978, 41445989, 41446007, 41446024, 41446039, 41446044, 41446080, 41446117, 41446144, 41446150, 41446211, 41446212, 41446216, 41446217, 41446223, 41446277, 41446290, 41446292, 41446323, 41446363, 41446796, 41446807, 41446808, 41455880, 41455893, 41455894, 41455896, 41455900, 41455902, 41455906, 41455910, 41455924, 41455932, 41455955, 41586608, 41612034, 41622975, 41630856, 41691748, 41747146, 41755552, 41765492, 41779600, 41779610, 41787786, 41792527, 41792800, 41792812, 41793875, 41793888, 41795224, 41796153, 41851761, 41903418, 41903960, 41956849, 42028108, 42038023, 42046538, 42057714, 42057739, 42063953, 42066520, 42067846, 42095488, 42172062, 42197144, 42206171, 42225697, 42288802, 42304719, 42313004, 42323439, 42365781, 42366186, 42371287, 42393465, 42393532, 42394081, 42478916, 42508767, 42552595, 42635362, 42635423, 42635426, 42638228, 42638512, 42638525, 42639096, 42668010, 42799507, 42799589, 42799745, 42802803, 42811500, 42812038, 42816302, 42823758, 42826856, 42826863, 42878485, 42881036, 42881266, 42892018, 42892404, 42892430, 42892474, 42919054, 42919085, 42967816, 42985101, 42985218, 43067304, 43082276, 43084042, 43084220, 43084414, 43119111, 43120325, 43151051, 43165011, 43179280, 43180544, 43209312, 43209348, 43209356, 43209360, 43230259, 43259235, 43263118, 43270340, 43305020, 43320930, 43340698, 43392727, 43420965, 43421081, 43433587, 43438771, 43443629, 43445198, 43446897, 43592438, 43594036, 43594037, 43613819, 43618965, 43622121, 43689832, 43704085, 43708891, 43709318, 43718660, 43719245, 43720499, 43720519, 43720660, 43720677, 43720776, 43721160, 43721227, 43721256, 43721670, 43756720, 43848518, 43902667, 43914262, 43931289, 43971849, 43973609, 43973613, 44004308, 44004309, 44015656, 44026775, 44035662, 44038398, 44065220, 44203373, 44320671, 44339387, 44388661, 44450326, 44536044, 44536281, 44604746, 44620455, 44621056, 44642682, 44643966, 44644567, 44649231, 44650811, 44654610, 44654626, 44654678, 44654764, 44743567, 44743568, 44830153, 44866223, 44879032, 44881204, 44891499, 45072647, 45103403, 45109943, 45168574, 45217802, 45321194, 45405221, 45412976, 45414258, 45428128, 45428705, 45428708, 45485899, 45509016, 45632472, 45632486, 47158877, 47312619, 49599010, 49599013, and 49599014;
2) Each unit is identified with a SITE number: 76992, 103526, 103581, 103921, 104020, 104021, 104068, 104386, 104497, 104628, 104926, 104950, 104953, 104959, 105184, 105399, 105581, 105585, 105654, 504655, 504674, 504733, 504742, 504779, 504868, 504921, 505067, 505068, 505120, 505356, 505380, 505530, 505611, 505703, 505903, 506008, 506026, 506069, 506119, 506509, 506655, 519118, 519136, 519196, 519197, 519678, 519730, 519981, 520275, 520582, 520666, 520688, 520756, 520793, 520949, 520964, 521149, 521325, 521525, 522136, 522456, 530396, 530653, 530654, 530660, 531649, 531758, 531799, 531926, 531939, 532152, 532218, 532240, 532241, 532383, 532614, 533288, 533290, 533397, 534131, 534156, 534786, 535345, 535761, 535775, 536028, 536031, 536034, 536035, 536037, 536042, 536171, 536715, 536789, 536899, 537175, 537593, 537631, 537804, 538028, 538095, 538099, 538157, 538172, 538387, 538409, 538514, 538516, 539213, 539326, 539628, 540184, 540237, 540461, 540721, 541237, 541238, 541239, 541276, 541577, 541589, 541590, 542382, 542413, 542557, 542714, 542963, 543289, 543411, 543690, 543879, 543953, 543989, 544306, 544395, 544543, 544635, 544656, 544668, 544844, 545025, 545262, 545396, 545518, 545583, 545604, 545753, 545882, 545884, 545997, 546013, 546119, 546149, 546569, 546906, 547173, 547215, 547431, 547642, 547715, 547769, 547823, 547922, 548005, 548020, 548036, 548082, 548140, 548288, 548383, 548618, 549202, 549242, 549368, 549370, 549903, 550198, 550691, 550758, 550812, 550935, 551855, 552355, 552599, 552639, 552969, 553685, 553699, 553766, 554763, 554802, 554970, 555293, 555299, 555356, 555834, 558604, 558945, 41443586, 41443609, 41443627, 41443647, 41443727, 41443765, 41443804, 41443909, 41444645, 41444647, 41444650, 41444689, 41444752, 41444816, 41445118, 41445432, 41445448, 41445501, 41445538, 41445615, 41445628, 41446230, 41446262, 41446773, 41455885, 41455897, 41455920, 41455925, 41455933, 41455944, 41455953, 41660520, 41780160, 41793290, 41795344, 41796154, 42046093, 42046440, 42057324, 42064058, 42067824, 42394072, 42479274, 42508759, 42553772, 42564341, 42625859, 42735090, 42891020, 42891095, 42891704, 43043666, 43058934, 43164789, 43173591, 43315510, 43436747, 43443622, 43453735, 43635004, 43670742, 43848923, 44028554, 44066424, 44584972, 44616211, 44654768, 44735751, and 44892370
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems – North America Co. Phillips, Bothell, WA, by letters on February 4, 2010.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator are damaged and the system can not be restarted.
VOLUME OF PRODUCT IN COMMERCE
1) 1,470 units; 2) 267 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters. Product # AK-11142-B. Recall # Z-2488-2010;
2) Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features). Product # AK-12702-SP. Recall # Z-2489-2010;
3) Multi-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features). Product # AK-15703-BCDC. Recall # Z-2490-2010;
4) Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS Catheter and Sharps Safety Features. Product # ASK-42703-PSBM. Recall # Z-2491-2010;
5) Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter. Product # CA-22702. Recall # Z-2492-2010;
6) Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Product # CDC-45802-B1A. Recall # Z-2493-2010;
7) Arterial Catheterization Set. Product # CK-04018. Recall # Z-2494-2010;
8) Femoral Artery Catheterization Set. Product # GH-04150. Recall # Z-2495-2010;
9) Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter. Product # NR-22802-B. Recall # Z-2496-2010
CODE
1) Lot # RF0033311;
2) Lot # RF0020305;
3) Lot # RF0019654;
4) Lot # RF9126852;
5) Lot # RF0033779;
6) Lot # RF9127302;
7) Lot No's: RF0019104 and RF0022537;
8) Lot # RF0019161;
9) Lot # RF0033406
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letter dated July 23, 2010. Firm initiated recall is ongoing.
REASON
Incorrectly assembled 18 Ga x 2 ½ Introducer Needle.
VOLUME OF PRODUCT IN COMMERCE
5,085 units
DISTRIBUTION
Nationwide, Australia, New Zealand, Europe
___________________________________
PRODUCT
1) Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an in vitro diagnostic reagent for the qualitative identification by light microscopy of human thyroid transcription factor-1 in formalin-fixed, paraffin- embedded tissue by immunohistochemical staining using the automated Bond system; Catalog No.: PA0364. Recall # Z-2497-2010;
2) Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL lyophilized tissue culture supernatant in vials; an in vitro diagnostic reagent for the qualitative identification by light microscopy of thyroid transcription factor-1 molecules in paraffin-embedded tissue by immunohistochemical staining; Catalog No.: NCL-TTF-1. Recall # Z-2498-2010;
3) Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 1 mL liquid tissue culture supernatant in a 1 mL vial; an in vitro diagnostic reagent for the qualitative identification by light microscopy of thyroid transcription factor-1 molecules in paraffin-embedded tissue by immunohistochemical staining; Catalog No.: NCL-L-TTF-1. Recall # Z-2499-2010
CODE
1) Lot numbers: 05918, 06912, 07104, 08679, 09261, 10480, and 10903;
2) Lot numbers: 136439, 136442, 136441S, 136447, 6000563 and 6004009;
3) Lot numbers: L136434, L136437, L136443, L136446, 6000568 and 6002638
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Bannockburn, IL, by letter dated July 28, 2010.
Manufacturer: Leica Biosystems Newcastle Ltd., Newcastle Upon Tyne, UK. Firm initiated recall is ongoing.
REASON
In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor types other than is currently indicated on the instructions for use.
VOLUME OF PRODUCT IN COMMERCE
860 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
GreenLight HPS fiber optics, Model Number 10-2090. Potentially Mislabeled as GreenLight PV 10-2079. Recall # Z-2502-2010
CODE
Manufactured between August 21 and October 31, 2009-- Lot number/Affected units: 932: D, N, U, Z; 933: A, C, F, H, K, L, M, T; 934: B, D, N, U, V, W, Y, Z; 935: A, C, F, H, K, L, M, T; 936: B, D, N, U, V, W, Y, Z; 937: A, C, F, H, K, L, M, T; 938: B, D, N, U, V, W, Y, Z; 939: A, B,L, M, T, V, W, Y; 940: B, D, N, U, V, W, Y, Z
RECALLING FIRM/MANUFACTURER
AMS Innovative Center – San Jose, San Jose, CA, by letter on January 12, 2010. Firm initiated recall is ongoing.
REASON
Product may be packed with incorrect external or internal labels and/or missing product insert.
VOLUME OF PRODUCT IN COMMERCE
4,226 units
DISTRIBUTION
Nationwide, Great Britain, Canada, Australia
___________________________________
PRODUCT
GATOR. REF 9263A, 4.2mm Sterling Blade, Sterile RX Only. Recall # Z-2503-2010
CODE
Lot number: 178026
RECALLING FIRM/MANUFACTURER
Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter, e-mail, Fax beginning August 5, 2010. Firm initiated recall is ongoing.
REASON
Breech in the sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
174 units
DISTRIBUTION
WA, AZ, PA, KS, NM, UT, ID, IL, Australia
___________________________________
PRODUCT
1) Modular Microplasty Cup inserter 3/8" thread, REF 31-400600. Recall # Z-2504-2010;
2) Modular Microplasty Cup impactor 1/4" - 28 thread insert, REF 31-400605. Recall # Z-2505-2010
CODE
1) Lot numbers: 658180, 658190 and 907630;
2) Lot numbers: 106623, 106624, 106625, 106626, 106627, 106628 110405 and 110423
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letters on July 28, 2010. Firm initiated recall is ongoing.
REASON
There was a clerical error in order entry which resulted in the recalling firm receiving spring components from a supplier made of "music wire" The recalling firm conducted tests to determine the effects of the change in materials. The testing showed that the wire would oxidize and there would be early failure of the device.
VOLUME OF PRODUCT IN COMMERCE
331 units
DISTRIBUTION
Nationwide, Australia, Canada, Mexico, Chile, Japan
___________________________________
PRODUCT
Concept Grafix Tendon Stripper. REF TS8850. 7.0MM, Qty 1. Rx Only, Non-Sterile, Made In USA. Recall # Z-2585-2010
CODE
Lot Numbers: 11708A, 11708B, 11708C, 11708D, 11708E
RECALLING FIRM/MANUFACTURER
Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letters on January 29, 2010. Firm initiated recall is ongoing.
REASON
There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.
VOLUME OF PRODUCT IN COMMERCE
149 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Engenex Non Acute Care Suction Cup for use with Engenex Negative Pressure Wound Therapy. 1) Product Order Number: #446600 (post acute); 2) Product Order Number: 446610 (acute); 3) Product Order Number: 446620 (demo unit). Recall # Z-2609-2010
CODE
There are three (3) affected Products, each with multiple different serial/lot numbers. Each seperate device shipped has its own serial/lot number.
1) Serial numbers: 600200 600201 600202 600203 600204 600205 600206 600208 600209 600210 600214 600217 600221 600222 600225 600228 600230 600233 600257 600263 600266 600277 600280 600286 600288 600296 600301 600302 600312 600333 600338 600342 600343 600351 600352 700386 700394 700401 700403 700404 700447 700450 700455 700456 700457 700460 700467 700470 700473 700476 700478 700479 700480 700481 700482 700485 700488 700491 700492 700493 700498 700501 700507 700509 700515 700516 700530 700536 700543 700546 700554 700564 700565 700568 700569 700571 700572 700574 700575 700576 700586 700587 700594 700596 700597 700606 700607 700608 700612 700613 700615 700621 700622 700625 700634 700635 700638 700639 700641 700649 700651 700655 700659 700665 700683 700709 700711 700745 700748 700749 700755 700756 700767 700772 700774 700782 700793 700794 700798 700800 700809 700814 700816 700819 700827 700833 700847 700856 700870 700874 700876 700878 700883 700888 700891 700893 700940 700945 700946 700947 700950 700951 700958 700959 700960 700962 700963 700966 700970 700973 700977 700983 700984 700997 700998 700999 701004 701013 701015 701021 701023 701024 701026 701027 701030 701035 701039 701052 701055 701065 701068 701076 701079 701081 701085 701086 701095 701099 701101 701104 701117 701124 701125 701126 701130 701134 701135 701158 701161 701163 701164 701169 701171 701172 701174 701177 701179 701180 701181 701183 701184 701185 701187 701188 701189 701190 701293 701294 701302 701344 701353 701356 701360 701361 701369 701384 701392 701393 701419 701420 701423 701425 701428 701429 701430 701432 701433 701434 701435 701437 701491 701492 701493 902036 902100 902106 902108 902111 902112 902113 902114 902115 902122 902126 902127 902128 902131 902134 902136 902137 902138 902140 902142 902143 902144 902145 902146 902147 902148 902149 902150 902151 902154 902155 902162 902163 902164 902165 902166 902167 902168 902169 902170 902171 902172 902173 902174 902175 902176 902177 902178 902179 902180 902181 902182 902183 902184 902185 902187 902188 902190 902191 902192 902193 902194 902195 902196 902197 902205 902216 902219 902223 902225 902227 902228 902229 902231 902232 902233 902235 902249 902254 902257 902258 902268 902270 902271 902277 902281 902282 902284 902299 902300 902301 902303 902307 902309 902311 902313 902314 902315 902316 902318 902320 902321 902322 902323 902324 902326 902327 902328 902329 902330 902331 902332 902333 902334 902335 902336 902337 902338 902339 902340 902341 902342 902343 902344 902345 902346 902347 902348 902349 902350 902351 902352 902353 902354 902355 902356 902357 902358 902359 902360 902361 902362 902363 902364 902365 902366 902367 902368 902370 902371 902372 902373 902374 902432 902456 905933 905987 905989 905990 905993 906003 906009 906015 906016 906017 906024 906025 906026 906027 906028 906040 906041 906051 906055 906057 906058 906059 906060 906061 906062 906063 906064 906065 906066 906067 906074 906075 906076 906077 906078 906079 906083 906084 906085 906086 906087 906088 906089 906090 906091 906092 906094 906095 906096 906097 906098 906099 906100 906101 906102 906103 906104 906105 906106 906107 906108 906110 906113 906122 906126 906130 906131 906133 906136 906140 906143 906149 906150 906155 906161 906163 906178 906180 906206 906207 906211 906212 906215 906217 906233 906316 906343 906346 906349 906350 906351 906361 906362 906365 906385 06J100 06J101 06J108 06J110 06J115 06J124 700762 700795 700815 701137 701153 701348 701363 600321 700597 700949 700919 700624 701001 700666 700985 06J113 701011 700846 701050 701037 600246 701025 700729 700727 700613 902238 700589 600227 700643 700541 600291 700826;
2) Serial numbers: 600229 600244 600247 600249 600254 600267 600278 600298 600303 600305 600313 600316 600320 600337 600347 600348 600350 700364 700365 700369 700371 700372 700373 700374 700375 700379 700380 700384 700387 700392 700393 700396 700407 700414 700416 700421 700422 700427 700429 700433 700435 700439 700440 700441 700443 700511 700527 700559 700573 700583 700626 700628 700630 700642 700646 700663 700678 700687 700690 700692 700702 700708 700721 700726 700738 700741 700744 700760 700764 700770 700771 700779 700781 700785 700786 700792 700796 700799 700802 700811 700820 700823 700825 700838 700839 700841 700848 700851 700852 700858 700859 700865 700866 700885 700887 700890 700895 700909 700912 700915 700917 700921 700922 700933 700964 700980 700981 700987 701016 701018 701034 701043 701200 701204 701236 701292 701295 701297 701298 701305 701306 701307 701310 701311 701312 701342 701347 701350 701355 701365 701366 701367 701368 701373 701375 701378 701379 701402 701404 701405 701406 701407 701408 701409 701410 701411 701412 701414 701416 701417 701421 701422 701438 701440 701441 701442 701443 701445 701447 701450 701452 701455 701456 701458 701462 701463 701465 701466 701471 701472 701474 701475 701478 701480 701481 701482 701483 701484 701487 701488 701490 902135 902198 902199 902200 902203 902204 902206 902207 902208 902209 902213 902214 902217 902220 902221 902222 902224 902226 902230 902240 902241 902248 902250 902251 902252 902253 902256 902260 902261 902263 902264 902276 902280 902285 902286 902287 902295 902297 902306 902497 902505 902506 902507 902513 902514 902516 902517 902519 902520 902521 902522 902523 902604 902605 902616 902621 902625 902664 902665 902672 902686 902691 902698 902701 902722 902726 902731 902747 902807 902845 902847 902848 902851 902857 902858 902859 902861 902862 902863 902866 902867 902868 902871 902874 902876 902877 902878 902879 903406 904161 904361 904365 904449 904489 904490 904998 904999 905000 905435 905451 905562 905565 905569 905570 905584 905588 06J107 06J119 700542 700904 700961 700972 701439 701448 701451 902245 902246 902291 902325 902503 902613 902684 902699 902734 902846 902850 902852 600258 600265 600287 600294 600310 600315 600328 600334 600339 600344 600353 700357 700359 700373 700382 700390 700400 700406 700413 700415 700417 700419 700423 700426 700430 700431 700432 700486 700539 700561 700562 700620 700644 700662 700679 700699 700701 700718 700720 700725 700732 700733 700735 700739 700740 700769 700776 700778 700807 700821 700822 700828 700835 700836 700849 700855 700861 700884 700892 700911 700920 700923 700935 700936 700937 700971 700974 701033 701056 701071 701078 701082 701083 701175 701313 701314 701315 701316 701317 701318 701319 701320 701321 701322 701323 701324 701325 701326 701327 701328 701329 701330 701331 701332 701333 701334 701335 701336 701337 701339 701372 701397 701401 701418 701426 701449 701453 701454 701457 701459 701460 701461 701462 701463 701464 701465 701468 701469 701479 701485 902210 902211 902212 902236 902237 902239 902242 902243 902244 902247 902250 902272 902275 902293 902298 902305 902317 902496 902498 902502 902525 902603 902606 902607 902608 902612 902619 902622 902626 902627 902630 902631 902632 902633 902636 902638 902640 902641 902642 902643 902644 902660 902666 902667 902668 902669 902670 902727 902729 902849 902853 902854 902855 902856 902861 902864 902865 903219 903328 903406 904130 904572 904988 905014 905452 905453 06J104 06J105 06J106 06J117 06J120;
3) Serial numbers: 700991 700994 700995 700996 701009 701092 701109 701118 701119 701129 701139 701141 701142 701144 701156 701168 701170 701194 701203 701206 701224 701226 701228 701230 701235 701241 701246 701247 701251 701254 701262 701264 701266 701268 701270 701273 701279 701284 701285 701290 701291 701303 701304 701308 701349 701394 701395 701427 701489 902000 902002 902003 902007 902013 902018 902019 902020 902021 902027 902032 902034 902041 902043 902044 902052 902053 902055 902057 902058 902065 902071 902074 902076 902078 902081 902087 902088 902089 902090 902091 902094 902095 902096 905968 905969 905970 905971 905972 906851 906852 906853 906868 906869 906870 906871 906872 906875 906876 906877 906878 906879 906880 906881 906882 906890 906891 906892 906893 906895 906896 906897 906899 906900 906901 906902 906903 906905 906906 906908 906909 906910 906911 906925 906928 906929 906930 906931 906932 906933 906934 906935 906936 906937 906938 906939 906940 906941 906942 906943 906944 906945 906946 906947 906948 906949 906954 906955 906958 906959 906960 906961 906962 906963 906964 906966 906968 906970 906972 906973 906974 906977 906998 907015 902079 701261 902054 701274 701245 902066 902068
RECALLING FIRM/MANUFACTURER
Recalling Firm: Convatec, Inc., Skillman, NJ, by letters on July 9, 2010.
Manufacturer: Boehringer Wound Systems, LLC, Norristown, PA. Firm initiated recall is ongoing.
REASON
Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity.
VOLUME OF PRODUCT IN COMMERCE
1,190 units
DISTRIBUTION
Nationwide
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PRODUCT
1) AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code: 6066. Recall # Z-2656-2010;
2) Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code: 6067. Recall # Z-2657-2010
CODE
1) Lot Numbers: 010/09, 011/09, 012/09;
2) Lot Numbers: 010/09, 011/09, 012/09, 013/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien LP, Mansfield, MA, by letter beginning August 11, 2010.
Manufacturer: Arrow Medical Limited, Herefordshire, UK. Firm initiated recall is ongoing.
REASON
Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization.
VOLUME OF PRODUCT IN COMMERCE
855 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Access Immunoassay Systems Free T4, Part Number: 33880. Recall # Z-2658-2010
CODE
Lot Number: 916293
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, letter was sent on March 24, 2010.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
Kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results.
VOLUME OF PRODUCT IN COMMERCE
10,826 units
DISTRIBUTION
Nationwide and Canada
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
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PRODUCT
1) UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy. Recall # Z-2500-2010;
2) UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy. Recall # Z-2501-2010
CODE
1) Code number 15L3; lot numbers 0115299, Exp. 4.12.2010; 0632299, Exp. 7/30/2010; 0811039, Exp. 10/20/2009; Code number 15L5; lot numbers 0135029, Exp. 3.4.2010; 0221099, Exp. 4/12/2010; 0311179, Exp 5/27/2010; 0634299, Exp. 7/30/2010 and 0814039, Exp. 10/20/2010; Code number 15L8: lot numbers: 0136029, Exp. 3/4/2010; 0220099, Exp. 04/12/2010; 0627299, Exp. 07/30/2010; 0817039, Exp. 10/20/2010;
2) Code number 16B4; lot numbers 0224099, Exp. 7/9/2010; 0618299, Exp 10/30/2010; 0818039, Exp. 1/11/2011 and 1010168, Exp. 3/20/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inverness Medical Professional Diagnostics, Princeton, NJ, by letters on February 12, 2010.
Manufacturer: NERL Diagnostics Corp., East Providence, RI. Firm initiated recall is ongoing.
REASON
Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the UCG-Beta Slide Monoclonal II test.
VOLUME OF PRODUCT IN COMMERCE
1,637 kits
DISTRIBUTION
Nationwide and Australia
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
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PRODUCT
"***Merrick***TEXAS HOLD 'EMS***A SCRUMPTIOUS BEEF LUNG TREAT FOR DOGS***DOG TREATS***10 oz. Recall # V-001-2011
CODE
Lot#: 10127; Item #: 60016 BEST BY MAY 6, 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tejas Industries Inc., Hereford, TX, by email and press release on August 3, 2010.
Manufacturer: Tejas Industries Inc., Plainview, TX. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
83 Cases X 12 packages each
DISTRIBUTION
WI, NY, IL, WA, CA, PA, MA, MI
END OF ENFORCEMENT REPORT FOR OCTOBER 20, 2010
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