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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Class I Veterinary Event

Event ID63137
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBreeders Choice Pet Foods Inc
CityIrwindale
StateCA
CountryUS
Distribution PatternU.S. states to include California, Georgia, Illinois, Nevada, Ohio, Virginia, and Washington.
 

Associated Products

Product DescriptionAvoDerm Natural Lamb Meal Brown Rice Adult Dog Formula, 26 lb. Packaged in plastic bag with plastic liner.
Code InfoProduct Code/SKU/Material # 1000065074, UPC Code 0 5290702043 8, Best before dates of 28 Aug 2013, 29 Aug 2013, 30 Aug 2013.
ClassificationClass I
Reason for RecallThe firm recalled because the product has the potential to be contaminated with Salmonella.
Product Quantity7,392 bags
Recall NumberV-126-2013

Class I Devices Event

Event ID63319
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmVycor Medical, Inc.
CityBoca Raton
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
 

Associated Products

Product DescriptionVycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Code InfoModel # TC171105 Lot # VM83450
ClassificationClass I
Reason for RecallVycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Product Quantity3000 devices
Recall NumberZ-0673-2013

Class I Veterinary Event

Event ID63454
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDel Monte Corp
CitySan Francisco
StateCA
CountryUS
Distribution PatternProducts were distributed nationwide.
 

Associated Products

Product DescriptionNature's Recipe, Oven Baked Biscuits with Real Chicken, Made with sweet potatoes, oats, flaxseed., 19 ounces; UPC: 30521 51549
Code InfoUPC: 30521 51549 Lot code: 2199TP; Best by: 10/11/13 Lot code: 2200TP; Best by: 10/12/13
ClassificationClass I
Reason for RecallProduct may be contaminated with Salmonella.
Product Quantity4282 cases ( 6 unit/ case)
Recall NumberV-120-2013

Class I Veterinary Event

Event ID63513
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWildwood Seeds
CityMonroe
StateOR
CountryUS
Distribution PatternProducts are distributed in Oregon and Washington
 

Associated Products

Product DescriptionPet Bird Feed- Sleek and Sassy are sold under multiple names. Products with UPCs are listed below. Garden Conure has the following UPCs: 0-1253111602-0; 0-1253111604-4; 0-1253111620-4; 0-1253111640-2; Garden Large Hookbill has the following UPCs: 0-1253113102-3; 0-1253113104-7; 0-1253113120-7; 0-1253113140-5; Garden Large Hookbill No Sunflower has the following UPCs: 0-1253113202-0; 0-1253113204-4; 0-1253113220-4; 0-1253113240-2; Garden Parrot has the UPCs: 0-1253112103-1; 0-1253112125-3; Nutty Garden Grain has the UPCS: 0-1253115502-9; 0-1253115504-3; 0-1253115520-3; 0-1253115540-1; Garden Macaw has the UPCs: 0-1253115602-6; 0-1253115604-0; 0-1253115620-0; 0-1253115640-8; Garden Complete Pellet has the UPCs: 0-1253115702-3; 0-1253115704-7; 0-1253115720-7; 0-1253115740-5; Fruit Veggie Nut Treat has the UPCs: 0-1253114302-6; 0-1253114304-0; 0-1253114320-0; 0-1253114316-3; 0-1253114332-3;
Code InfoNo expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
ClassificationClass I
Reason for RecallPet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Product Quantityapproximately 4904 lbs.
Recall NumberV-121-2013
Product DescriptionSmall Pet Animal Food is sold under Sleek and Sassy brand. Product are packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag. Garden Small Animal has the following UPCs: 0-1253113902-9; 0-1253113904-3; 0-1253113920-3; 0-1253113940-1;
Code InfoNo expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
ClassificationClass I
Reason for RecallPet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Product Quantityapproximately 566 lbs.
Recall NumberV-122-2013
Product DescriptionGarden Guinea Pig/Rabbit diet is sold under Sleek and Sassy brand. Product is packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag. Garden Guinea Pig/Rabbit has UPC is 0-1253113502-1.
Code InfoNo expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
ClassificationClass I
Reason for RecallPet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Product Quantityapproximately 984 lbs.
Recall NumberV-123-2013
Product DescriptionFortified feeds are sold under Sleek and Sassy brand. Different products with UPCs are listed below. Fortified Large Hookbill with the UPCs: 0-1253111402-6; 0-1253111404-0; 0-1253111420-0; 0-1253111440-8; Fortified Large Hookbill No Sunflower with the UPCs: 0-1253111502-3; 0-1253111504-7; 0-1253111520-7; 0-1253111540-5; Fortified Parrot with the UPCs: 0-1253113003-3; 0-1253113025-5; Fortifed Small Animal with the UPCs: 0-1253112902-0; 0-1253112904-4; 0-1253112920-4; 0-1253112940-2;
Code InfoNo expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
ClassificationClass I
Reason for RecallPet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Product Quantityapproximately 1560 lbs.
Recall NumberV-124-2013

Class I Veterinary Event

Event ID63537
StatusTerminated
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHBD International
CityBrentwood
StateTN
CountryUS
Distribution PatternOR
 

Associated Products

Product DescriptionWILD WINGS, CERTIFIED ORGANIC, PREMIUM ORGANIC BLEND, PREMIUM SEED FOR BIRDS, Net wt. 80 oz (5 lbs) (2.27 kg), HBD INTERNATIONAL, 7108 CROSSROADS BLVD., SUITE 325 BRENTWOOD, TN 37027, 615.221.9890 800.346.0269
Code InfoPOM9512WL2201A4
ClassificationClass I
Reason for RecallProduct was manufactured with peanuts recalled by Sunland due to the potential for salmonella contamination.
Product Quantity36 units
Recall NumberV-125-2013

Class I Veterinary Event

Event ID63606
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWixon, Inc.
CitySaint Francis
StateWI
CountryUS
Distribution PatternCA, IL, GA, NJ, CT, KS, MN, MA, WA, ME, NY.
 

Associated Products

Product DescriptionCharlee Bear Protein Crunch Bars, 84% Chicken Recipe with Sweet Potatoes, 5.5 oz, UPC Code 8710890001.
Code InfoLot # 20112
ClassificationClass I
Reason for RecallCharlee Bear Products, a division of Wixon, Inc., is voluntarily recalling certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella.
Product Quantity444 cases (12 pouches/case)
Recall NumberV-127-2013
Product DescriptionCharlee Bear Protein Crunch Bars, 84% Chicken Recipe with Carrots, 5.5 oz, UPC Code 8710890000.
Code InfoLot # 19812, 19912, 20012, 20212.
ClassificationClass I
Reason for RecallCharlee Bear Products, a division of Wixon, Inc., is voluntarily recalling certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella.
Product Quantity448 cases (12 pouches/case)
Recall NumberV-128-2013

Class I Food Event

Event ID63677
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFrito Lay, Inc
CityPlano
StateTX
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionGrandma's Peanut Butter Sandwich Creme Cookies, Net WT. 3.025 oz, Frito-Lay, Inc. Plano, TX 75024
Code InfoGRANDMA'S Peanut Butter Sandwich Creme cookies have a sell-by date of March 12, 2013 or earlier and UPC code of 28400-00153.
ClassificationClass I
Reason for RecallThe firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg.
Product Quantity12,000 cases (720,000 units) of the 3.025 oz & 3,378 cases (202,000 units) of the 1.71 oz
Recall NumberF-0877-2013
Product DescriptionGrandma's Peanut Butter Mini Sandwich Creme Cookies, Net WT. 1.71 oz, Frito-Lay, Inc. Plano, TX 75024
Code InfoGRANDMA'S Peanut Butter Mini Sandwich Creme cookies have a sell-by date of May 21, 2013 or earlier and UPC code of 28400-00901. The sell-by date is located on the front of the package.
ClassificationClass I
Reason for RecallThe firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg.
Product Quantity
Recall NumberF-0878-2013

Class I Devices Event

Event ID63698
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBausch and Lomb, Incorporated
CityAliso Viejo
StateCA
CountryUS
Distribution PatternWorldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time.
 

Associated Products

Product DescriptionBausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
Code InfoB100003G B100015A B100015D B100023A B100023B B100023C B100023D B100023E B100039D B100039F B100046A B100046B B100046C B100058A B100069A B110027D B110028C B110048A B110048D B110056A B120011D B120016A D100008B D100009A D100011A D100011B D100011C D100016B D100016C D100022A D100022B D100022C D100022D D100026A D100026C D100026D D100026E D100030A D100030B D100030C D100035A D100035C D100035D D100043A D100043B D100043C D100044B D100044C D100044D D100044E D100045A D100045B D100045C D100059A D100059B D100059C D100060A D100060B D100061A D100061B D100080A D100081A D100081AS D110015A D110015B D110016A D110045A D110046A D110047A D110070A D110071A D110072A D110090A D110090B D110091A D110092A D110108A D110108B D110108BR D120015A D120015B D120027A D120028A D120029A D120029B D120038B D120039A D120068A D120068B 023632 023633 023639 023640 023647 023801 023811 023863 023886 023897 023920 023933 023972 024022 024025 024028 024257 024323 024436 C10003B E090105A D090095B D090096A D090096C D090097C D090097D Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L)
ClassificationClass I
Reason for RecallSome disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents, detachment has resulted in serious patient injury.
Product Quantity2,342,294
Recall NumberZ-0672-2013

Class I Food Event

Event ID63839
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmSugar Flowers Plus
CityGlendale
StateCA
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionPastillage (gum paste) Flowers
Code InfoRose - Pink UPC code: 8 38437 00003 0
ClassificationClass I
Reason for RecallSugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall NumberF-0899-2013
Product DescriptionPastillage (gum paste) Flowers
Code InfoRose - Yellow UPC code: 8 38437 00001 6
ClassificationClass I
Reason for RecallSugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall NumberF-0900-2013
Product DescriptionPastillage (gum paste) Flowers
Code InfoRose - Red UPC code: 8 38437 00002 3
ClassificationClass I
Reason for RecallSugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall NumberF-0901-2013
Product DescriptionPastillage (gum paste) Flowers
Code InfoRose - Blue UPC code: 8 38437 00004 7
ClassificationClass I
Reason for RecallSugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall NumberF-0902-2013
Product DescriptionPastillage (gum paste) Flowers
Code InfoCymbidium - W/M UPC Code: 8 38437 00010 8
ClassificationClass I
Reason for RecallSugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall NumberF-0903-2013
Product DescriptionPastillage (gum paste) Flowers
Code InfoCattleya - W/P UPC code: 8 38437 00011 5
ClassificationClass I
Reason for RecallSugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall NumberF-0904-2013
Product DescriptionPastillage (gum paste) Flowers
Code InfoGladiolus - A/W UPC ocde: 8 38437 00012 2
ClassificationClass I
Reason for RecallSugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall NumberF-0905-2013
Product DescriptionPastillage (gum paste) Flowers
Code InfoGladiolus - P/BUR UPC code: 8 38437 00013 9
ClassificationClass I
Reason for RecallSugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall NumberF-0906-2013

Class I Food Event

Event ID63910
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOcean Beauty Seafoods, LLC
CitySeattle
StateWA
CountryUS
Distribution PatternNationwide to distributors and retailers in AZ, CA, CO, CT, MA, NH, NJ, NY, OR, PA, RI, TX and WA.
 

Associated Products

Product DescriptionCold-smoked salmon in vacuum plastic bags that are partially clear and partially colored black, white, gold and pink, labeled in part: front panel: ***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***NET WT 3 OZ (85g)*** back panel: ***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***This salmon can be frozen for up to 45 days. Thaw under refrigeration. Once opened, keep refrigerated and be sure to enjoy within five days. Keep refrigerated at 38F or below.***0 73030 80368 2***INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE. DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM FARM RAISED PRODUCT OF CHILE A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632
Code InfoPack Date: 285 UPC: 0 73030 80368 2;
ClassificationClass I
Reason for RecallOcean Beauty Seafood's sample was found positive for Listeria monocytogenes.
Product Quantity272 cases - 12/3 ounce packages per case. The press release had reported 275 cases had been distributed, but that was incorrect.
Recall NumberF-0913-2013
Product DescriptionCold-smoked salmon in vacuum plastic that are partially clear and partially colored blue, yellow, white, labeled in part: front panel: ***Lascco BRAND SLICED SMOKED NOVA SALMON NET WT 4 OZ (113g) PERISHABLE. KEEP REFRIGERATED AT 38F OR COLDER. back panel: ***Lascco BRAND SLICED SMOKED NOVA SALMON***0 72840 01751 7***INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE. DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM FARM RAISED PRODUCT OF CHILE A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632
Code InfoPack Date: 285 UPC: 0 72840 01757 7
ClassificationClass I
Reason for RecallOcean Beauty Seafood's sample was found positive for Listeria monocytogenes.
Product Quantity95 cases - 12/4 ounce packages per case. The press release reported 96 cases distributed, but that was incorrect.
Recall NumberF-0914-2013

Class I Food Event

Event ID63948
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCap Sur Mer, Inc.
CityL'etang Du Nord
State
CountryCA
Distribution PatternPortsmouth, NH; Raynham, MA; Taunton, MA
 

Associated Products

Product DescriptionNautifish Frozen Cooked Lobster Meat. CKL 12 X 11.3 oz. Metal Cans. 12 items/case. Keep Frozen.
Code InfoDates of Manufacture: 10/5/12, 11/4/12, 11/5/12, 11/6/12, 11/7/12. Date Codes: 12 309 to 12 312, Lot #50979 R, Product #12834. Date Code: 12 279. Lot #48213 R, Product number: 12834
ClassificationClass I
Reason for RecallThis product was found with Listeria monocytogenes through laboratory analysis.
Product Quantity244 cases of 12 X 11.3oz cans
Recall NumberF-0907-2013
Product DescriptionApollo Frozen Cooked Lobster Meat. BCKL Lobster Meat 6X2 lb, plastic bags, 6 individual items per case, keep frozen
Code InfoDate of Manufacture: 10/05/12; Lot # 11244
ClassificationClass I
Reason for RecallThe product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Product Quantity101 cases - 6 X 2lb per case
Recall NumberF-0908-2013
Product DescriptionCaptain Homard Frozen Cooked Lobster Meat. Broken Tail Meat, 6X2 lb, plastic bags, 6 individual items per case. Keep Frozen.
Code InfoDate of Manufacture: 10/05/12, 11/05/12, 11/06/12, 11/07/12. Date Code: 12 279: #48293 R; #16046; 12 310, 12 311, 12 312 Lot# 50028 R
ClassificationClass I
Reason for RecallThe product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Product Quantity12 Cases - 6 X 2lb plastic bags/case
Recall NumberF-0909-2013
Product DescriptionFrozen Cooked Lobster Tail Meat. Nautifish. 2 lb plastic bags, 6 items/case. Keep Frozen
Code InfoDate of Manufacture: 10/05/12. Date Code 12 279; Product Number: 339538
ClassificationClass I
Reason for RecallThe product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Product Quantity3 cases- 6 X 2 lb plastic bags/case
Recall NumberF-0910-2013
Product DescriptionFrozen Cooked Lobster Meat. Salad Meat 6 X 2 lb. plastic bags, 6 individual items per case. Captain Homard and Apollo. Keep Frozen
Code InfoDate of Manufacture: 11/04/12, 11/05/12, 11/06/12, 11/07/12; Date Code: 12 309 - 12 312; Lot #50019 and 50432R for Captain Homard; Lot #50020 for Appolo Product #15721
ClassificationClass I
Reason for RecallThis product was found with Listeria monocytogenes through laboratory analysis.
Product Quantity780 cases - 6 X 2lb plastic bags/case
Recall NumberF-0911-2013
Product DescriptionFrozen Cooked Lobster Meat. TCK Nautifish 6 X 2 lbs. Plastic Bags, 6 individual per case. Keep Frozen
Code InfoDate of Manufacture: 11/05/12, 11/06/12; Date Code: 12 310 - 12 311. Lot #50022 R, Product # 339 703
ClassificationClass I
Reason for RecallThe product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Product Quantity13 cases - 6 X 2 lb plastic bags per case
Recall NumberF-0912-2013

Class I Food Event

Event ID64030
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmSomersault Snack Co., LLC
CitySausalito
StateCA
CountryUS
Distribution PatternNationwide and Canada
 

Associated Products

Product DescriptionSomersault brand Cinnamon Crunch. Crunchy nuggets baked with sunflower seeds and toasted grains. Sunflower seed snack. .5 oz, 1 oz., 2 oz., 6 oz., and 16 oz.
Code InfoCinnamon Crunch 12ct; 6oz. Case Code10-8-98403-002-27-4;Product Code 8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 16ct; 2oz.Case Code10-8-98403-002-27-4; Product Code8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 100ct; 0.5oz., Case Code10-8-98403-002-24-3; Product Code 8-98403-002-24-6; Sell By: 8/30/2013 or earlier Cinnamon Crunch 36ct; 1oz.Case Code10-8-98403-002-23-6; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier, Cinnamon Crunch 50ct; 1oz., Case Code 10-8-98403-002-22-9; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier Cinnamon Crunch Bulk 8ct; 16oz. (for samples only, no case and product code)Sell By: 8/30/2013 or earlier Shipper 36ct; 1oz. SS CC, Case Code10-8-98403-002-26-7; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier
ClassificationClass I
Reason for RecallDuring ingredient review for kosher certification, the firm discovered that the finished product package did not bear a milk allergen declaration, although a flavor ingredient was found to contain milk
Product Quantity36,757 cases
Recall NumberF-0879-2013

Class I Food Event

Event ID64046
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jan-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmWoodstock Farms
CityEdison
StateNJ
CountryUS
Distribution PatternAlabama, Connecticut, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and District of Columbia
 

Associated Products

Product DescriptionWoodstock All Natural Tamari Almonds, 7.5 OZ in a gusseted re-sealable poly bag.
Code InfoBest By: 10/24/13 Lot: 12298 UPC# 0-42563-00838-3
ClassificationClass I
Reason for RecallUndeclared soy ingredient on mislabeled back panel. While the Tamari Almonds contain soy, the ingredient statement does not include soy. In addition, the nutrition facts and UPC# are incorrect which corresponds to another almond product. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
Product Quantity67 cases, each containing 8 packages per shipping case
Recall NumberF-0886-2013

Class II Biologics Event

Event ID39136
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternPA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09FN91160
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-0171-13

Class II Biologics Event

Event ID39579
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CitySioux City
StateIA
CountryUS
Distribution PatternSouth Dakota, Austria
 

Associated Products

Product DescriptionRed Blood Cells
Code Info1970058
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0406-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info1970058
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0407-13

Class II Biologics Event

Event ID39636
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jan-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CitySioux City
StateIA
CountryUS
Distribution PatternIA, SD
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info1959203;1959203
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-0473-13

Class II Biologics Event

Event ID39765
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells
Code Info11FM49562
ClassificationClass II
Reason for RecallBlood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
Product Quantity1 unit
Recall NumberB-0364-13

Class II Biologics Event

Event ID40317
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-May-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info011LF20539
ClassificationClass II
Reason for RecallBlood product, with platelet yield that exceeded the manufacturer's limit for the product to be stored in one bag, was distributed.
Product Quantity1 Unit
Recall NumberB-0167-13

Class II Biologics Event

Event ID41296
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Dec-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoLX44682
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1 Unit
Recall NumberB-0173-13

Class II Biologics Event

Event ID43372
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBaylor University Medical Center - Transfusion Service Center
CityDallas
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info49GN54061
ClassificationClass II
Reason for RecallBlood product, labeled with an incorrect expiration date, was distributed.
Product Quantity1 unit
Recall NumberB-0363-13

Class II Biologics Event

Event ID45352
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUniversity of Texas Medical Branch at Galveston (The)
CityGalveston
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells
Code Info4066720
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0372-13

Class II Biologics Event

Event ID47050
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045007915604
ClassificationClass II
Reason for RecallBlood product, which was possibly contaminated with Propionibacterium species, was distributed.
Product Quantity1 Unit
Recall NumberB-0366-13

Class II Biologics Event

Event ID47138
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jan-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045007915029 Part 1 ;W045007915029 Part 2
ClassificationClass II
Reason for RecallBlood products, which were possibly contaminated with Propionibacterium species, were distributed.
Product Quantity2 Units
Recall NumberB-0365-13

Class II Biologics Event

Event ID47987
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW045008007317 Part A ;W045008007317 Part B
ClassificationClass II
Reason for RecallBlood products, which failed to meet the minimum specification for product volume, were distributed
Product Quantity2 Units
Recall NumberB-0367-13

Class II Biologics Event

Event ID48910
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternMaryland.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21KM96454
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported post donation illness, was distributed.
Product Quantity1 component
Recall NumberB-0166-13

Class II Biologics Event

Event ID49326
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternCalifornia.
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info21KT41666; 21KT41666
ClassificationClass II
Reason for RecallBlood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Product Quantity2 components
Recall NumberB-0168-13

Class II Biologics Event

Event ID49869
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternOregon and California.
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info21FP45176
ClassificationClass II
Reason for RecallBlood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Product Quantity1 component
Recall NumberB-0169-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info21FP45176
ClassificationClass II
Reason for RecallBlood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Product Quantity1 component
Recall NumberB-0170-13

Class II Biologics Event

Event ID49930
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInterstate Blood Bank Inc Mo
CitySaint Louis
StateMO
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code InfoLZ090296; LZ089770
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity2 Units
Recall NumberB-0077-13

Class II Biologics Event

Event ID50052
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Sep-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternOregon.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21LZ02870; 21LZ07089; 21LZ10267; 21LZ14250.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity4
Recall NumberB-0174-13

Class II Biologics Event

Event ID50418
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Oct-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityPortland
StateOR
CountryUS
Distribution PatternOregon.
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info21LQ32862, 21LQ32862
ClassificationClass II
Reason for RecallBlood product, collected from a donor with an unacceptably low hemoglobin, was distributed.
Product Quantity2 components
Recall NumberB-0458-13

Class II Drugs Event

Event ID62237
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmJames G. Cole, Inc.
CityHood River
StateOR
CountryUS
Distribution PatternProduct was distributed nationwide and Canada
 

Associated Products

Product DescriptionI-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Code InfoN/A
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Product Quantity253 bottles
Recall NumberD-129-2013

Class II Devices Event

Event ID62719
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Spine, Inc.
CityRaynham
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
 

Associated Products

Product DescriptionDePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
Code InfoAll lots
ClassificationClass II
Reason for RecallA component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.
Product Quantity140 units
Recall NumberZ-0685-2013

Class II Devices Event

Event ID63393
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution-USA including the states of AZ, CA, CO, IL, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA and WI and the countries of Austria, Canada, China, France, India, Ireland, Italy, Japan, Netherlands, Norway, Spain, Switzerland, Thailand and United Kingdom.
 

Associated Products

Product DescriptionComputed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data.
Code InfoModel #728269; Serial #s: 79906, 79921, 79927, 79937, 80007, 80026, 80031, 80040, 80058, 80062, 80066, 80069, 80087, 80110, 80121, 80155, 80167, 80168, 80169, 80174, 80192, 80193, 80195, 80201, 80208, 80209, 80219, 80227, 80228, 80230, 80252, 80258, 80266, 80280, 80289, 80293, 80294, 80315, 80322, 80328, 80333, 80340, 80341, 80348, 80360, 80375, 80385, 80387, 80394, 80398, 80416, 80421, 80422, 80429, 80447, 80451, 80460, 80474, 80482, 80484, 80485, 80492, 80497, 80505, 80516, 80578, 80585, 80591, 80629, 80646, 80658, 80681, 80704, 80709, 80711, 80720, 80723, 80743, 80749, 80751, 80831, 80835, 80866, 80878, 80908, 80909, 80911, 80914, 80916, 80930, 80931, 80944, 80974, 80992, 80999, 81023, 81025, 81034, 81045, 81071, 81099, 81101, 81107, 81117, 81126, 81136, 95382 & 95592.
ClassificationClass II
Reason for RecallPhilips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.
Product Quantity108 units
Recall NumberZ-0675-2013

Class II Biologics Event

Event ID63417
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeShare Blood Centers
CityTexarkana
StateTX
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036511025390
ClassificationClass II
Reason for RecallBlood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-0373-13

Class II Devices Event

Event ID63771
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPerkinelmer
CityWaltham
StateMA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionNEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
Code InfoLot Numbers: 617341, 619236
ClassificationClass II
Reason for RecallTruncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity180 kits (20 plates/kit)
Recall NumberZ-0686-2013
Product DescriptionNEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Code InfoLot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
ClassificationClass II
Reason for RecallTruncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity819 kits (10 plates/kit)
Recall NumberZ-0687-2013
Product DescriptionNEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Code InfoLot Numbers: 618201, 619200, 618263
ClassificationClass II
Reason for RecallTruncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)
Recall NumberZ-0688-2013
Product DescriptionDBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
Code InfoLot Numbers: 618609
ClassificationClass II
Reason for RecallTruncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity56 kits (100 plates/kit)
Recall NumberZ-0689-2013
Product DescriptionMicroplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
Code InfoLot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175
ClassificationClass II
Reason for RecallTruncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity
Recall NumberZ-0690-2013

Class II Devices Event

Event ID63817
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden.
 

Associated Products

Product DescriptionBrilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code InfoBrilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S. was: 9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were: 300018, and 300003. The remaining Serial Numbers distributed overseas were: 91003, 95130, 95157, 95504, and Serial Numbers: 300010, and 300030 .
ClassificationClass II
Reason for RecallSoftware anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
Product QuantityA total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)
Recall NumberZ-0674-2013

Class II Food Event

Event ID63851
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUnilever United States, Inc.
CityEnglewood Cliffs
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionKnorr Pasta Sides Cheesy Bacon Macaroni Net Wt. 3.8 oz, (107 g) Unilever Englewood Cliffs, NJ 07632 USA Made in Canada from domestic and imported ingredients Case SCC 10041000082488 UPC 4100008248
Code InfoSept1113BUO Sept1213BUO
ClassificationClass II
Reason for RecallKnorr Pasta Sides Cheesy Bacon Macaroni may contain soy as a different product mix was inadvertently packaged in the Cheesy Bacon Macaroni pouch.
Product Quantity16,500 puches
Recall NumberF-0880-2013

Class II Devices Event

Event ID63863
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide Distribution, including the states of PA, OH, NY, CA and IL.
 

Associated Products

Product DescriptionHoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Code InfoCatalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.
ClassificationClass II
Reason for RecallTwo complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
Product Quantity476 units
Recall NumberZ-0695-2013

Class II Veterinary Event

Event ID63880
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternAlabama, Colorado, District of Columbia, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia.
 

Associated Products

Product DescriptionPlum A+ Single Channel Infusion Pump with Module for Veterinary Use Only; Hospira, Inc., Lake Forest, IL 60045; list number 60529, module 60530-04
Code InfoList number 60529, serial numbers 14315003, 14315004, 14315005, 14315008, 14315009, 14315011, 14315012, 14315013, 14315014, 14315015, 14315017, 14315018, 14315019, 14315020, 14315022, 14315023, 14315025, 14315026, 14315027, 14315028, 14315029, 14315030, 14315031, 14315034, 14315035, 14315036, 14315037, 14315038, 14315040, 14315041, 14315043, 14315044, 14315045, 14315046, 14315047, 14315048, 14315049, 14315050, 14315051, 14315052, 14315053, 14315054, 14315055, 14315056, 14315057, 14315058, 14315059, 14315061, 14315062, 14315063, 14315064, 14315066, 14315067, 14315069, 14315070, 14315071, 14315072, 14315073, 14315074, 14315075, 14315076, 14315077, 14315078, 14315079, 14315080, 14315081, 14315082, 14315083, 14315084, 14315085, 14315086, 14315087, 14315088, 14315089, 14315090, 14315091, 14315092, 14315093, 14315094, 14315095, 14315096, 14315097, 14315098, 14315099, 14315100, 14315101, 14315103, 14315104, 14315105, 14315106, 14315109, 14315110, 14315111, 14315112, 14315113, 14315114, 14315116, 14315117, 14315118, 14315119, 14315120, 14315121, 14315123, 14315124, 14315125, 14315126, 14315127, 14315128, 14315129, 14315130, 14315131, 14315132, 14315133, 14315134, 14315135, 14315136, 14315137, 14315138, 14315139, 14315140, 14315141, 14315142, 14315143, 14315145, 14315146, 14315147, 14315148, 14315149, 14315150, 14315151, 14315152, 14315153, 14315154, 14315155, 14315156, 14315157, 14315158, 14315159, 14315160, 14315161, 14315162, 14315163, 14315164, 14315165, 14315166, 14315167, 14315168, 14315169, 14315170, 14315171, 14315172, 14315173, 14315174, 14315175, 14315176, 14315177, 14315178, 14315179, 14315180, 14315181, 14315182, 14315183, 14315184, 14315185, 14315186, 14315187, 14315188, 14315189, 14315190, 14315191, 14315192, 14315193, 14315194, 14315195, 14315196, 14315197, 14315198, 14315199, 14315200, 14315201, 14315202, 14315203, 14315204, 14315205, 14315207, 14315208, 14315209, 14315210, 14315211, 14315212, 14315213, 14315214, 14315215, 14315216, 14315217, 14315218, 14315219, 14315220, 14315221, 14315223, 14315224, 14315225, 14315226, 14315227, 14315228, 14315229, 14315230, 14315231, 14315232, 14315233, 14315234, 14315235, 14315236, 14315237, 14315238, 14315239, 14315240, 14315241, 14315242, 14315243, 14315244, 14315245, 14315246, 14315247, 14315248, 14315249, 14315250, 14315251, 14315252, 14315253, 14315254, 14315255, 14315256, 14315257, 14315258, 14315259, 14315260, 14315261, 14315262, 14315263, 14315264, 14315265, 14315266, 14315267, 14315268, 14315269, 14315270, 14315271, 14315272, 14315273, 14315274, 14315275, 14315276, 14315277, 14315278, 14315279, 14315280, 14315281, 14315282, 14315283, 14315284, 14315285, 14315286, 14315287, 14315288, 14315289, 14315290, 14315291, 14315293, 14315294, 14315295, 14315296, 14315297, 14315298, 14315299, 14315300, 14315301, 14315302, 14315303, 14315304, 14315305, 14315306, 14315307, 14315308, 14315309, 14315310, 14315311, 14315312, 14315313, 14315314, 14315315, 14315316, 14315317, 14315318, 14315319, 14315320, 14315321, 14315322, 14315323, 14315324, 14315325, 14315326, 14315327, 14315328, 14315329, 14315330, 14315331, 14315332, 14315333, 14315334, 14315335, 14315336, 14315337, 14315338, 14315339, 14315340, 14315341, 14315342, 14315343, 14315344, 14315345, 14315346, 14315347, 14315348, 14315349, 14315350, 14315351, 14315352, 14315353, 14315354, 14315355, 14315356, 14315357, 14315358, 14315359, 14315360, 14315361, 14315362, 14315363, 14315364, 14315365, 14315366, 14315367, 14315368, 14315369, 14315370, 14315371, 14315372, 14315373, 14315374, 14315375, 14315376, 14315377, 14315378, 14315379, 14315380, 14315381, 14315382, 14315383, 14315384, 14315385, 14315386, 14315387, 14315388, 14315389, 14315390, 14315391, 14315392, 14315393, 14315394, 14315395, 14315396, 14315397, 14315398, 14315399, 14315400, 14315401, 14315402, 14315403, 14315404, 14315405, 14315406, 14315407, 14315408, 14315409, 14315410, 14315411, 14315412, 14315413, 14315414, 14315415, 14315416, 14315417, 14315418, 14315419, 14315420, 14315421, 14315422, 14315423, 14315424, 14315425, 14315426, 14315427, 14315428, 14315429, 14315430, 14315431, 14315432, 14315433, 14315434, 14315435, 14315436, 14315437, 14315438, 14315439, 14315440, 14315441, 14315442, 14315443, 14315444, 14315445, 14315446, 14315447, 14315448, 14315449, 14315450, 14315451, 14315452, 14315453, 14315454, 14315455, 14315456, 14315457, 14315458, 14315459, 14315460, 14315461, 14315462, 14315463, 14315464, 14315465, 14315466, 14315467, 14315468, 14315469, 14315470, 14315471, 14315472, 14315473, 14315474, 14315475, 14315476, 14315477, 14315478, 14315479, 14315480, 14315481, 14315482, 14315483, 14315484, 14315485, 14315486, 14315487, 14315488, 14315489, 14315490, 14315491
ClassificationClass II
Reason for RecallThe volume control knob on some Plum A+ infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Product Quantity467 pumps
Recall NumberV-119-2013

Class II Devices Event

Event ID63931
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpacelabs Healthcare, Llc
CityIssaquah
StateWA
CountryUS
Distribution PatternWorldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India.
 

Associated Products

Product DescriptionSpacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary. The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
Code InfoICS G2 Smart Disclosure Model 92810, Version 4.03. There are no serial numbers.
ClassificationClass II
Reason for RecallDisplaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.
Product Quantity17 in US and 6 International
Recall NumberZ-0694-2013

Class II Food Event

Event ID63943
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNaturally Fresh Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternU.S.
 

Associated Products

Product DescriptionMarketside, Chunky Bleu Cheese Dressing, Net Wt. 14 fl. oz (414)mL, Manufactured For Marketside, a division of Wal-Mart Stores, Inc., Bentonville, AR 72716.
Code InfoLot code 81H09062; Best By 01/04/13; UPC 6 81131 02900 1
ClassificationClass II
Reason for RecallUndeclared Allergen: Dairy
Product Quantity978 cases
Recall NumberF-0885-2013

Class II Drugs Event

Event ID63966
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmL. Perrigo Co.
CityAllegan
StateMI
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPrednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.
Code InfoLot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13
ClassificationClass II
Reason for RecallPresence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Product Quantity86,616 Tablets
Recall NumberD-125-2013

Class II Food Event

Event ID63995
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDollar Tree Distribution, Inc.
CityChesapeake
StateVA
CountryUS
Distribution PatternNationwide and Canada
 

Associated Products

Product DescriptionCandy Canes, Peppermint Flavor, 5 oz boxes, packed 12 individually candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA***
Code InfoBatch number: YT-0112003 01880-001 120521 01880-001 120605
ClassificationClass II
Reason for RecallCandy product may contain metal and/or plastic pieces embedded in the candy.
Product Quantity3,147,956 boxes
Recall NumberF-0882-2013
Product DescriptionCandy Canes, Cherry Flavor, 5 oz boxes, packed 12 candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA***
Code InfoBatch number: 01880-001 120504
ClassificationClass II
Reason for RecallCandy product may contain metal and/or plastic pieces embedded in the candy.
Product Quantity1,257,120 boxes
Recall NumberF-0883-2013

Class II Food Event

Event ID64006
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLocal Baking, Co, Inc. T/A Joey's Fine Foods
CityNewark
StateNJ
CountryUS
Distribution PatternNew York and New Jersey
 

Associated Products

Product DescriptionJOEY'S GOURMET LEMON CAKE; NET WT 3 oz. (85 g); UPC 026104613403; Joey's Fine Foods, Inc., Newark, NJ 07104; 973-482-1400
Code InfoAll lots
ClassificationClass II
Reason for RecallProduct contains undeclared FD&C Yellow #5.
Product Quantity160 cases (12, 3-oz. units in each)
Recall NumberF-0881-2013

Class II Devices Event

Event ID64007
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternNationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).
 

Associated Products

Product DescriptionSarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code InfoLot number: 0677286 and Catalog number: 13010.
ClassificationClass II
Reason for RecallFlexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity6830 total units for all products
Recall NumberZ-0666-2013
Product DescriptionSarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code InfoLot number: 0677284 and Catalog number: 13020
ClassificationClass II
Reason for RecallFlexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity6830 total all products
Recall NumberZ-0667-2013
Product DescriptionSarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code InfoLot number: 067728 and 0681074 and Catalog number: 13030
ClassificationClass II
Reason for RecallFlexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity6830 total all products
Recall NumberZ-0668-2013
Product DescriptionSarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code InfoLot number: 0677294, 0680693, 0682187 and Catalog number: 12315
ClassificationClass II
Reason for RecallFlexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity6830 total all products
Recall NumberZ-0669-2013
Product DescriptionSarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code InfoLot number: 0680122, 0680751and Catalog number: 12325
ClassificationClass II
Reason for RecallFlexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity6830 total all products
Recall NumberZ-0670-2013
Product DescriptionSarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code InfoLot number: 0677299 and Catalog number: 12325X
ClassificationClass II
Reason for RecallFlexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity6830 total all products
Recall NumberZ-0671-2013

Class II Food Event

Event ID64012
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmS & M International Inc
CityBayonne
StateNJ
CountryUS
Distribution PatternNY, MI, PA, KY, West Virginia
 

Associated Products

Product DescriptionYangsheng Eggs Preserved Duck Eggs Content 6 pcs Net Wt: approx 12.69 oz (360g) S&M (USA) Enterprise Corp Rm3 8/F., Yuexiu Bldg., 160-174 Lockhart Road, Wan Chai, HK Distributed by : S & M Int'l Inc 100 Pulaski ST., Bayonne NJ 07002 Product of China UPC 6949682803551
Code InfoLot YS12-02A
ClassificationClass II
Reason for RecallPreserved Duck Eggs do not meet pH standard of 10 for boiled/preserved eggs.
Product Quantity855 cases (24 individual packages of eggs)
Recall NumberF-0884-2013

Class II Devices Event

Event ID64039
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmQuanta System, S.p.A.
CitySolbiate Olona (VA)
State
CountryIT
Distribution PatternClass II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
 

Associated Products

Product DescriptionQ-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.
Code InfoAll codes and devices are applicable.
ClassificationClass II
Reason for RecallQuanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Product Quantity75 units
Recall NumberZ-0691-2013
Product DescriptionEterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
Code InfoAll codes and devices are applicable.
ClassificationClass II
Reason for RecallQuanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Product Quantity12 units
Recall NumberZ-0692-2013
Product DescriptionUltrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.
Code InfoAll codes and devices are applicable.
ClassificationClass II
Reason for RecallQuanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Product Quantity22 units
Recall NumberZ-0693-2013

Class III Biologics Event

Event ID38551
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Feb-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPenrose-St Franc Health Services Blood Bank
CityColorado Springs
StateCO
CountryUS
Distribution PatternCO
 

Associated Products

Product DescriptionBlood and Blood Products for reprocessing
Code Info2284245; 2285158
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed.
Product Quantity2
Recall NumberB-0175-13

Class III Biologics Event

Event ID49181
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services LP
CityIndependence
StateMO
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08IMOB1579; 08IMOA6642; 08IMOA3960
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity3 units
Recall NumberB-0072-13

Class III Drugs Event

Event ID61725
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Code InfoLot number 6A007046V, exp 07/12
ClassificationClass III
Reason for RecallImpurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Product Quantity13,232 bottles
Recall NumberD-128-2013

Class III Devices Event

Event ID63768
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresenius Medical Care Holdings, Inc.
CityWaltham
StateMA
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionFresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Numbers: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity101,108 units
Recall NumberZ-0676-2013
Product DescriptionFresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity17,782 units
Recall NumberZ-0677-2013
Product DescriptionFresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Numbers:12NXGF002, 12NXGF014, 12PXGF006,
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity14,240 units
Recall NumberZ-0678-2013
Product DescriptionFresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Numbers:12NXGF005, 12NXGF019, 12PXGF008
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity13,409 units
Recall NumberZ-0679-2013
Product DescriptionFresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Number:12NXGF009
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity5 units
Recall NumberZ-0680-2013
Product DescriptionFresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Numbers:12NXGF011, 12PXGF004
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity5,689 units
Recall NumberZ-0681-2013
Product DescriptionFresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Number:12NXGF012
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity2493 units
Recall NumberZ-0682-2013
Product DescriptionFresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Number:12PXGF017
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity670 units
Recall NumberZ-0683-2013
Product DescriptionFresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code InfoLot Number:12PXGF002
ClassificationClass III
Reason for RecallGranuFlo Dry Acid Concentrate may show discoloration
Product Quantity2711 units
Recall NumberZ-0684-2013

Class III Drugs Event

Event ID63952
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBoehringer Ingelheim Roxane Inc
CityColumbus
StateOH
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPerindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Code InfoLot #160017A, Exp 04/2013.
ClassificationClass III
Reason for RecallImpurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Product Quantity3,553 bottles
Recall NumberD-126-2013

Class III Drugs Event

Event ID64085
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUpsher Smith Laboratories, Inc.
CityMaple Grove
StateMN
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionDivalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
Code InfoLot #: 310162, Exp 09/14
ClassificationClass III
Reason for RecallLabeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Product Quantity11,316 bottles
Recall NumberD-127-2013

Mixed Classification Food Event

Event ID63843
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresh Unlimited Inc
CitySidney
StateOH
CountryUS
Distribution PatternProduct was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.
 

Associated Products

Product DescriptionRed Apple Slices 2.4 oz, Item #71746, 20 oz, Item # 71729 14 oz, Item # 71735. Item #71729 is sold under the brand name Sonic UPC 95829 20000. The other two packages are in clear plastic bags.
Code Info2 oz Use By 11/30/12 Item #71729, UPC 95829 2000, 2 oz, Use By 12/3/12, Item #71746; & 14 oz, Use By 12/3/12 & 12/6/12 Item # 71735.
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product QuantityItem #71729-359 cs/18/2 oz bags, Item #71746-127 cs/24/2 oz bags & Item #71735-127 cs/6/14 oz bags
Recall NumberF-0887-2013
Product DescriptionSliced Green Apples READY TO EAT 14 oz Innerlock Bag UPC 95829 20042 Use By: 12/3/12, Item #71736
Code InfoItem #71736, Use By 12/3/2012 and 12/6/2012
ClassificationClass I
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity291 cs/6/14 oz bags
Recall NumberF-0888-2013
Product DescriptionCelery Stick 2, 80/2 oz clear plastic bag, Item #70648 USED BY: 11/21/12
Code InfoUse by 11/21/12 Item# 70648
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity68 cs/80/2 oz bags
Recall NumberF-0889-2013
Product DescriptionCarrot coin 1/4 & 80/2oz bag Item #70263 BEST USED BY 11/21/12 TC: 1 317 2359 15:43
Code InfoUse by 11/21/12 Item# 70263
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity6 cs/80/2 oz bags
Recall NumberF-0890-2013
Product DescriptionRed Grapes 80/1.5 oz (3,402g) bag Item #71305 BEST USED BY: 11/21/12
Code InfoUse by 11/21/12 Item #71305
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity6 cs/80/1.5 oz bags
Recall NumberF-0891-2013
Product DescriptionPineapple Chunks 80/2 oz (4.536g) bag Item #71607, BEST USED BY: 11/21/12 TC: 1 217 2359
Code InfoUse by 11/21/12
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product QuantityItem #7160763 cs/80/2 oz bags
Recall NumberF-0892-2013
Product DescriptionRed Apples DICED 3/4 & 5/1# (4,536G) bag Item #71707 Ingredients: Apples (Apples, Calcium Ascorbate), BEST USED BY: 11/25/12 TC: 1 317 2359 15:40 PRODUCT OF: USA
Code InfoUse by 11/25/12 Item #71707
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity143 cs/5/1 lb bags
Recall NumberF-0893-2013
Product DescriptionGreen Pepper Strips 3/8 & 80/2oz (4,536g) bag Item #73032 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45
Code InfoUse by 11/21/12 Item #73032
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity22 cs/80/2 oz bags
Recall NumberF-0894-2013
Product DescriptionRadish Sliced 80/2oz bag Item #74605 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45
Code InfoUse by 11/21/12
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity2 cs/80/2 oz (4,536g) bags
Recall NumberF-0895-2013
Product DescriptionHoliday Fruit Delight Kit 5.1875 lbs (2,353g) INGREDIENTS: APPLES***RED GRAPES, STRAWBERRY GLAZE***MARSHMELLOW***WALNUTS, ALLERGENS: WALNUTS (TREE NUTS) BEST USED BY 11/23/12 TC: 13171319 15:42
Code InfoUse by 11/23/12 ITEM #74707
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity6 cs/5.1875 lb bags
Recall NumberF-0896-2013
Product DescriptionWaldorf Salad Kit 5.19lb (2,345g) bag Item #74802 INGREDIENTS: APPLES***MAYONNAISE***CELERY, WALNUTS CONTAINS: SOYBEAN OIL, EGG, TREE NUTS (WALNUTS) BEST USED BY: 11/23/12 TC: 13171319 15:43
Code InfoUse by 11/23/12 Item #74802
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity75 cs/5.19 lb bags
Recall NumberF-0897-2013
Product DescriptionSHREDDED BROCCOLI FRUIT SALAD 6.19# (2,807 g) Ingredients: Broccoli, Cauliflower, Apples, Pears, Cole Slaw Dressing***Cranberry***Raisins CONTAINS: Soybean, egg BEST USED BY: 11/23/12 TC: 13171319 15:59***
Code InfoUse by 11/23/12 Item #74880
ClassificationClass II
Reason for RecallPossible contamination with Listeria monocytogenes.
Product Quantity10 cs/6.19 lb bags
Recall NumberF-0898-2013

Mixed Classification Biologics Event

Event ID38910
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmARC Blood Services, New England Region
CityDedham
StateMA
CountryUS
Distribution PatternCA, MA, ME, NH, NY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Plasma Frozen
Code Info04FF62346, 04FF62348, 04FF62357, 04FF62358, 04FF62362, 04FF62364, 04FF62373, 04FF62376, 04FF62386, 04FF62389, 04FF62393, 04FF62402, 04FF62403, 04FF62405, 04FF62407, 04FF62412, 04FF62419, 04FF62421, 04FF62424, 04FF62426, 04FF62525, 04FF62530, 04FJ19204, 04FJ19228, 04FJ19233, 04FJ19236, 04FJ19245, 04FJ19247, 04FJ19253, 04FJ19263, 04FJ19270, 04FJ19272, 04FJ19277, 04FJ19281, 04FJ19284, 04FJ19295, 04FJ19297, 04FJ19303, 04FJ19312, 04FJ19317, 04FJ19324, 04FJ19333, 04FJ19337, 04FJ19488, 04FJ19500, 04FJ19505, 04FJ19507, 04FJ19591,
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity48
Recall NumberB-0368-13
Product DescriptionRed Blood Cells Rejuvenated Irradiated
Code Info04FJ19207, 04FJ19217, 04FJ19220, 04FJ19224. 04FJ19230, 04FJ19476,04FJ19487, 04FJ19595, 04FJ19601
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity9
Recall NumberB-0369-13
Product DescriptionPlasma Frozen
Code Info04FF62362,04FF62364,04FJ19247,04FJ19324
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity4
Recall NumberB-0370-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info04FF62350, 04FF62352, 04FF62357, 04FF62358, 04FF62376, 04FF62386,04FF62396, 04FF62405, 04FF62407,04FF62421, 04FF62424, 04FJ19204, 04FJ19228, 04FJ19230, 04FJ19233, 04FJ19245, 04FJ19270, 04FJ19272,04FJ19277. 04FJ19284, 04FJ19295, 04FJ19317, 04FJ19333, 04FJ19495 04FJ19500, 04FJ19504, 04FJ19507
ClassificationClass III
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity27
Recall NumberB-0371-13

Mixed Classification Biologics Event

Event ID45119
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternPA, CO and CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info009FE12874; 09FQ21836
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0177-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info009GZ05786; 009GZ06597
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0178-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info009FE12874; 09FQ21836
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-0179-13

Mixed Classification Biologics Event

Event ID47684
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternWashington, Oregon, and California.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info21GV34559; 21KV00196; 21KV00328.
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3 components
Recall NumberB-0180-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21GV34559; 21KV00196; 21KV00328.
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3 components
Recall NumberB-0181-13

Mixed Classification Biologics Event

Event ID49720
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jul-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri; Texas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011GT77158; 011FX17525
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 Units
Recall NumberB-0182-13
Product DescriptionPlasma Frozen
Code Info011GT77158
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0183-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info011FX17525
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0184-13

Mixed Classification Biologics Event

Event ID49899
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternTennessee; Missouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011FZ82900
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0185-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info011FZ82900
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0186-13

Mixed Classification Biologics Event

Event ID50030
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityPortland
StateOR
CountryUS
Distribution PatternMaryland and California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21LZ09600
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-0459-13
Product DescriptionCryoprecipitated AHF
Code Info21LZ09600
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-0460-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info21LZ09600
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-0461-13

Mixed Classification Biologics Event

Event ID50567
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Nov-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri; California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011GG65599
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0187-13
Product DescriptionCryoprecipitated AHF
Code Info011GG65599
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0188-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info011GG65599
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0189-13

Mixed Classification Biologics Event

Event ID50593
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Oct-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityPortland
StateOR
CountryUS
Distribution PatternMassachusetts and California.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21FV31979
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-0462-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info21FV31979
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 component
Recall NumberB-0463-13
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