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Enforcement Report - Week of June 27, 2012

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Drugs Event

Event ID	61233
Status	Completed
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Nov-10
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Physicians Total Care, Inc
City	Tulsa
State	OK
Country	US
Distribution Pattern	FL

Associated Products

Product Description	Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
Code Info	PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00
Classification	Class I
Reason for Recall	Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Product Quantity	540 tablets (9 containers of 60 tablets each)
Recall Number	D-1385-2012

Product Description	Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00
Code Info	PTC Drug Number: 4973. PTC Batch Number: 65J2. Batch Date: 10/13/2010. Expiration Date: 06/30/2012. NDC: 54868-4973-00
Classification	Class I
Reason for Recall	Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Product Quantity	600 tablets (5 containers of 120 tablets each)
Recall Number	D-1386-2012

Class I Food/Cosmetics Event

Event ID	61497
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Mar-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Club Chef LLC
City	Covington
State	KY
Country	US
Distribution Pattern	Product was shipped to the following states: IL, IN, KY, OH, TN & VA.

Associated Products

Product Description	Salsa in 12 oz., 16 oz., and 5 lb. plastic containers. The product labels reads as follows: PREMIUM QUALITY Private Selection Natural*SALSA NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)INGREDIENTS: TomatoesJalapenoDISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 452021-800-697-2448" and PREMIUM QUALITY Private Selection Natural PICO DE GALLO NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)INGREDIENTS: TomatoesJalapenoDISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 452021-800-697-2448 and heinens" FreshSalsa All Natural Net. Wt. 16oz. (1lb) 454gIngredients: TomatoesJalapenoPACKED FOR HEINENS BY CLUB CHEF, LLC and heinens" Fresh Bruschetta All Natural Net. Wt. 16oz. (1lb) 454g Ingredients: TomatoesJalapeno*PACKED FOR HEINENS BY CLUB CHEF, LLC
Code Info	Private Selection Brand: PICO DE GALLO-UPC# 11111091135, HOT SALSA-UPC# 1111091139 & MILD SALSA-UPC# 1111091137; heinen's brand: HOT SALSA-UPC# 2060100024 & MILD SALSA-UPC# 2060100026. Both brands have Use By 3/27/12.
Classification	Class I
Reason for Recall	South Florida Produce of Boynton Beach in Florida shipped fresh jalapeno peppers to Castellini Company in Wilder Kentucky. Castellini shipped the peppers to a store in Ohio, where the Ohio Department of Agriculture collected a sample of these peppers which subsequently were found contaminated with Salmonella. This same lot of fresh peppers was shipped to Club Chef which manufactured the Salsa which is under recall and identified in this Recall Enterprise System document.
Product Quantity	422 cases
Recall Number	F-1443-2012

Class I Devices Event

Event ID	61639
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GE Healthcare, LLC
City	Waukesha
State	WI
Country	US
Distribution Pattern	Nationwide Distribution-including the states of AL, FL, GA, MO, and VA.

Associated Products

Product Description	GE Healthcare, Aestiva/5 7900 SmartVent", anesthesia machine, GE Healthcare P.O. Box 7550 Madison, WI 53707-7550. This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional). This device is to be used only by trained and qualified medical professionals
Code Info	Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969
Classification	Class I
Reason for Recall	GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This may cause prolonged or persistent hypotension requiring medical intervention. To date, no injury has been reported to GE Healthcare associated with this issue.
Product Quantity	8
Recall Number	Z-1787-2012

Class I Devices Event

Event ID	61843
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Nidek Medical Products Inc
City	Birmingham
State	AL
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ENGLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, KAZAKHSTAN, KINGDOM OF SAUDI ARABIA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPPINES, PORTUGAL, REPUBLIC OF CHINA, REPUBLIC OF SOUTH AFRICA, RUSSIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH AUSTRALIA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, THE NETHERLANDS, TOGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES, and VIETNAM.

Associated Products

Product Description	NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity	7889 units
Recall Number	Z-1774-2012

Product Description	NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity
Recall Number	Z-1775-2012

Product Description	NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity	82 units
Recall Number	Z-1776-2012

Product Description	NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity	335 units
Recall Number	Z-1777-2012

Product Description	NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity	730 units
Recall Number	Z-1778-2012

Product Description	NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity	3638 units
Recall Number	Z-1779-2012

Product Description	NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity	14,585 units
Recall Number	Z-1780-2012

Product Description	NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity	1599 units
Recall Number	Z-1781-2012

Product Description	NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
Code Info	Serial numbers 042-10000 through 102-07044
Classification	Class I
Reason for Recall	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Product Quantity	18114 units
Recall Number	Z-1782-2012

Class I Food/Cosmetics Event

Event ID	61893
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Santos Inc.
City	San Leandro
State	CA
Country	US
Distribution Pattern	Distributed to retail markets in Northern California.

Associated Products

Product Description	Santos Brand, Bulgar Wheat, flour packed in clear plastic bags, 2 lbs.
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1461-2012

Product Description	Santos Brand, All Purpose flour packed in clear plastic bags, 2 lbs, 5lbs
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1462-2012

Product Description	Santos Brand, Cinnamon Sticks packed in clear plastic bags, 7oz, 14oz
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1463-2012

Product Description	Santos Brand, Cumin Seeds packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1464-2012

Product Description	Santos Brand, Fennel Seeds packed in clear plastic bags, 3.5 ounces, 7 ounces, 14 ounces, 2 pounds
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1465-2012

Product Description	Santos Brand, Deggi Mirch (Red Capsicum & Kashmiri Red Chile Powder) packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1466-2012

Product Description	Santos Brand, Garam Masala (Indian Spice Mix) packed in clear plastic bags, 7 ounces, 16 ounces
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1467-2012

Product Description	Santos Brand, Ginger Powder packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1468-2012

Product Description	Santos Brand, Cardamom packed in clear plastic bags, 3.5 ounces, 7 ounces
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1469-2012

Product Description	Santos Brand, Whole Mace packed in clear plastic bags, 3.5 ounces, 7 ounces
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1470-2012

Product Description	Santos Brand, Mustard Seeds packed in clear plastic bags, 3.5 ounces, 16 ounces
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1471-2012

Product Description	Santos Brand, Urid Split (Lentils) packed in clear plastic bags, 2 pounds, 4 pounds
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1472-2012

Product Description	Santos Brand, Suji (Farina) packed in clear plastic bags, 2 pounds
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1473-2012

Product Description	Santos Brand, garbanzo beans packed in clear plastic bags, 2 pounds, 4 pounds
Code Info	There is no UPC code/lot code/expiration date on products.
Classification	Class I
Reason for Recall	The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour. The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Product Quantity
Recall Number	F-1474-2012

Class I Food/Cosmetics Event

Event ID	61896
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-May-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Gills Onions, LLC
City	Oxnard
State	CA
Country	US
Distribution Pattern	Worldwide to: Canada and nationwide to: retailers and foodservice distributors in California, Oregon, Washington, Arizona, Idaho, Texas, Illinois, Michigan, Arkansas, Ohio, Tennessee, New Jersey, Georgia, and Florida.

Associated Products

Product Description	Diced Red Onions, 7oz clear plastic clamshell labeled Gills Onions with the May 17, 2012 use by date, United States UPC 6 43550 00041 2. Fresh Diced Red Onions, Oignons rouges frais, en des, 198 grams, Canadian UPC 6 43550 00045 0.
Code Info	lot code 51RDA1A2119
Classification	Class I
Reason for Recall	The recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes.
Product Quantity	2,360 lbs total
Recall Number	F-1539-2012

Product Description	3/8" Diced Red Onions, 5 LB. Bag
Code Info	lot code 51RDA1A2119
Classification	Class I
Reason for Recall	The recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes.
Product Quantity	2,360 lbs total
Recall Number	F-1540-2012

Product Description	1/4" Diced Red Onions, 5 LB. Bag
Code Info	lot code 51RDA1A2119
Classification	Class I
Reason for Recall	The recall was initiated because Gills Onions, LLC was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes.
Product Quantity	2,360 lbs total
Recall Number	F-1541-2012

Class I Food/Cosmetics Event

Event ID	61970
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Oskri Organics Corp.
City	Lake Mills
State	WI
Country	US
Distribution Pattern	AZ, CA, DE, FL, GA, MD, MI, MN, NJ, NY, NC, OR, TX, UT, VA, WA.

Associated Products

Product Description	Oskri, Peach Granola, Gluten Free, Nut Free, Dairy Free, Vegan, Halal, Kosher, Ingredients: Buck Wheat , Peaches 20% Sunflower Seeds , Apricots, Date Syrup, Chicory Root extract, Rice protein., NET WT 3.5oz (100) G., UPC 66616111743, Oskri, Lake Mills, Wisconsin 53551.
Code Info	Lot 75, P: 3/3/12, EXP: 9/9/13
Classification	Class I
Reason for Recall	Oskri is recalling one lot of 3.53 oz bags of Peach Granola due to cashews being added to this product in error.
Product Quantity	1056 bags
Recall Number	F-1543-2012

Class I Food/Cosmetics Event

Event ID	62290
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-May-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Indonesian Food Mart
City	Rockville
State	MD
Country	US
Distribution Pattern	Product was distributed nationwide and internationally to Australia, Canada, Slovenia, New Zealand, Brunei, Darussalam, Poland and Croatia.

Associated Products

Product Description	Tempeh Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, Original, packaged in clear plastic packages in 30gm, 50gm, 250 gm, and 1000 gm sizes and labeled in part *Indonesianfoodmart.com*
Code Info	Product is not coded
Classification	Class I
Reason for Recall	Imported food product tested positive for Salmonella.
Product Quantity	123 orders were filled but quantities were not recorded on many invoices
Recall Number	F-1475-2012

Product Description	Tempeh Super Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, packaged in clear plastic packages in 30 gm, 50 gm, 250 gm, and 1000 gm sizes and labeled in part *Indonesianfoodmart.com*
Code Info	Product is not coded
Classification	Class I
Reason for Recall	Imported food product tested positive for Salmonella.
Product Quantity	123 orders were filled but quantities were not recorded on many invoices
Recall Number	F-1476-2012

Class II Devices Event

Event ID	57878
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-May-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	App Pharmaceuticals Llc
City	Schaumburg
State	IL
Country	US
Distribution Pattern	Nationwide Distribution and Puerto Rico

Associated Products

Product Description	HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Code Info	Lot 406952 (Expiration Date 02/11)
Classification	Class II
Reason for Recall	CGMP Deviations: Incomplete documentation associated with test results.
Product Quantity	133,150 vials
Recall Number	Z-1824-2012

Product Description	HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Code Info	Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
Classification	Class II
Reason for Recall	CGMP Deviations: Incomplete documentation associated with test results.
Product Quantity	Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Recall Number	Z-1825-2012

Class II Devices Event

Event ID	61253
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Feb-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American Optisurgical Inc
City	Lake Forest
State	CA
Country	US
Distribution Pattern	Nationwide distribution: MN only.

Associated Products

Product Description	TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Code Info	Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
Classification	Class II
Reason for Recall	Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Product Quantity	5units
Recall Number	Z-1817-2012

Class II Devices Event

Event ID	61376
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Nov-11
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Biomet 3i, LLC
City	Palm Beach Gardens
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.

Associated Products

Product Description	Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "*Certain 3.25, 13REF IOSM313 LOT OSSEOTITE Certain Implant3.25 x 13mmCE 0086Use by yyyy-mmSterile by radiation* STERILE R*Do not re-sterileRX only Caution: Law prohibits dispensing without prescriptiondo not use if package is damageddo not reuseconsult instructions for useSterile unless package is opened or damaged.** Product Usage: The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Code Info	Lot #2010111529
Classification	Class II
Reason for Recall	On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
Product Quantity	219 units in total
Recall Number	Z-1828-2012

Class II Food/Cosmetics Event

Event ID	61542
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Apr-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Pr Supplies Co., Inc.
City	Bayamon
State	PR
Country	US
Distribution Pattern	Puerto Rico only.

Associated Products

Product Description	"*Queso Blanco del PaisTRIDASReceta Original*"
Code Info	16/3/2012
Classification	Class II
Reason for Recall	PR State Department sampling found positive results for Clostridium Clostridioforme
Product Quantity	415 units
Recall Number	F-1457-2012

Product Description	"*Queso del PaisTRIDASPasta y Queso "Guayaba"*"
Code Info	16/3/2012
Classification	Class II
Reason for Recall	PR State Department sampling found positive results for Clostridium Clostridioforme
Product Quantity	300 units
Recall Number	F-1458-2012

Product Description	"*Queso del PaisTRIDASPasta y Queso "Mango"*"
Code Info	16/3/2012
Classification	Class II
Reason for Recall	PR State Department sampling found positive results for Clostridium Clostridioforme
Product Quantity	100 units
Recall Number	F-1459-2012

Class II Devices Event

Event ID	61741
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-10
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Medtronic Navigation, Inc.
City	Littleton
State	MA
Country	US
Distribution Pattern	Nationwide Distribution including the states of CO, IN, and MN.

Associated Products

Product Description	Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Code Info	Serial Numbers: 125, 156, 234R.
Classification	Class II
Reason for Recall	Software Version 3.1.1 does not meet navigational accuracy.
Product Quantity	3 units
Recall Number	Z-1849-2012

Class II Devices Event

Event ID	61742
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam.

Associated Products

Product Description	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 12315 and Lot codes: 0552019, 0557299, 0562142, 0572238, 0575869, 0579315, 0584831, 0590890, 0594622, 0598430, 0604045, 0612256, 0625339, 0640189, 0646473, 0652905, 0656574, 0666574, 0671713, and 593606C.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1832-2012

Product Description	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 12325 and Lot codes: 0551680, 0553010, 0557571, 0559882, 0562967, 0566831, 0569995, 0575870, 0579316, 0584969, 0589928, 0593454, 0595251, 0601331, 0606816, 0611597, 0617494, 0622167, 0626795, 0629156, 0632515, 0636330, 0640190, 0643858, 0649159, 0652241, 0656575, 0663510, and 621463C.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1833-2012

Product Description	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 12325X and Lot codes: 558946, 0589263, 0603353, 0640527, and 0653443.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1834-2012

Product Description	SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 13010 and Lot codes: 0590855, 0593791, 0597307, 0603718, 0616892, 0624831,0629341,0634937, 0636270, 0644444, 0646144, 0653230, 0666586, and 0669487.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1835-2012

Product Description	SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 13020 and Lot codes: 0550552, 0555854, 0557327, 0559103, 0562503, 0566861, 0570455, 0574279, 0577885, 0581606, 0585963, 0590856, 0593457, 0597308, 0605179, 0609199, 0614248, 0618969, 0626379, 0628950, 0634171, 0636332, 0640518, 0646396, 0653231, and 0666719.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1836-2012

Product Description	SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 13030 and Lot code: 0553041, 0555967, 0557330, 0559885, 0562990, 0564951, 0567668, 0570456, 0571580, 0575365, 0580822, 0583186, 0585529, 0590858, 0593455, 0596125, 0600250, 0605504, 0609198, 0614183, 0620033, 0623325, 0626858, 0634096, 0636271, 0638011, 0640980, 0650900, 0653232, and 628985C.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1837-2012

Product Description	SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 144776 and Lot code: 0552165, 0560615, 0574341, 0586004, 0606472, 0614321, 0617360, 0622689, 0637775, 0640519, and 0653855.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1838-2012

Product Description	24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 88813030 and Lot code: 0550551, 0568495, 0576844, 0586459, 0601958, 0626874, and 0635682.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1839-2012

Product Description	SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 64625 and Lot code: NA17, NC07A, NG06, NG06A, and NL19.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1840-2012

Product Description	CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 80001-01 and Lot code: MG21, MM04, NA24, ND21, NK01, NM31, and PA30.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1841-2012

Product Description	CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Info	Catalog number: 80004-02 and Lot code: MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23.
Classification	Class II
Reason for Recall	During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected. The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
Product Quantity	133,793 (each)
Recall Number	Z-1842-2012

Class II Devices Event

Event ID	61761
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Feb-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Accumetrics Inc
City	San Diego
State	CA
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Code Info	Lot # WK0002A WK0003A WK0003B WK0004A WK0005A WK0006A WK0006B WK0006AR WK0006BR WK0007A WK0008A WK0009A WK0010A WK0010B WK0010C WK0011A WK0012A WK0013A WL0001A WL0001B WK0014A WK0015A WL0003A WL0004A WK0016A WL0005A WL0006A WL0007A WK0017A WK0018A WL0007B WL0008A WK0018B WK0018-5A WL0008-5A WL0009A WL0009-5A WK0019A WL0009B WL0010A WL0010-5A WL0010B WL0011-5A WL0011A WL0013A WL0012A WL0012-5A WL0015-5A WL0015A WL0016-5A WL0016A WL0017A WL0018A WL0018-5A WL0019A WL0020A WL0020-5A WL0018B WK0020A WL0021A WL0022A WL0023A WL0023-5A WL0024A WL0024B WL0025A WL0026A WL0026A WL026-5A WL0027 WL0028 WL0029 WL0029A WL0029B WL0030 WL0031 WL0030A WL0033 WL0034 WL0035 WL0036 WL0038 WL0033A WL0039 WL0040 WL0040A WL0041 WL0042 WL0043 WL0044 WL0045 WL0046 WL0045A WL0049 WL0049A WL0051 WL0051A WL0052 WL0053 WL0055 WL0056 WL0057 WL0057A WL0059 WL0060 WL0061 WL0061A WL0062 WL0062A WL0061A WL0063 WL0062B WL0064 WL0065 WL0067 WL0069 WL0070 WL0071 WL0066A WL0068A WL0072 WL0073 WL0074 WL0075 WL0076 WL0078 WL0079 WL0080 WL0081 WL0076A WL0082 WL0083 WL0084 WL0088 WL0089A WL0091 WL0090 WL0093 WL0097 WL0098 WL0099 WL0101 WL0102 WL0105 WL0106 WL0108 WL0111 WL0111A WL0113 WL0117 WL0118
Classification	Class II
Reason for Recall	The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result which will be the only value reported.
Product Quantity	26,075 units
Recall Number	Z-1853-2012

Product Description	VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Code Info	Not available
Classification	Class II
Reason for Recall	The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result which will be the only value reported.
Product Quantity	1,167 units total
Recall Number	Z-1854-2012

Class II Food/Cosmetics Event

Event ID	61867
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Casa De Mesquite Llc
City	Hollister
State	CA
Country	US
Distribution Pattern	Product was released for distribution in US and Canada.

Associated Products

Product Description	Casa de Mesquite brand Mesquite Bean Flour, packaged in 10 kg bag in carton, and 13 kg bag in carton for food manufacturing, and 10, 24 and 44 oz retail bags; Product is processed and packaged by Casa de Mesquite, LLC, Hollister, CA
Code Info	Lot #: 123001
Classification	Class II
Reason for Recall	Recent tests show that one lot of this product has the potential to be contaminated with bacillus cereus, a spoilage organism which can cause diarrhea, nausea and other symptoms.
Product Quantity	375 x 13 kg cartons
Recall Number	F-1453-2012

Class II Devices Event

Event ID	61868
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-May-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Non-Invasive Monitoring Systems, Inc.
City	Miami
State	FL
Country	US
Distribution Pattern	Nationwide Distribution

Associated Products

Product Description	US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "*AT acceleration THERAPEUTICSAt Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201info@nims-inc.com www.nims-inc.comNIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.US-001 Rev A**" Printed marketing brochure
Code Info	Brochure US-001 Rev A
Classification	Class II
Reason for Recall	Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Product Quantity	US-001 Rev A brochure: 3665
Recall Number	Z-1819-2012

Product Description	USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST*A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaintsWhole Body Periodic Acceleration (WBPA)WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201info@nims-inc.com www.nims-inc.comNIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.USA-002 Rev A**" Printed marketing brochure
Code Info	Brochure USA-002 Rev A
Classification	Class II
Reason for Recall	Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Product Quantity	USA-002 Rev A brochure: 91
Recall Number	Z-1820-2012

Class II Devices Event

Event ID	61877
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	6 US customers

Associated Products

Product Description	Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Code Info	All systems with Eleva software version 4.x and stitching option.
Classification	Class II
Reason for Recall	If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be executed unnecessarily. Usability is identified to be the main contributing factor.
Product Quantity	6
Recall Number	Z-1821-2012

Class II Drugs Event

Event ID	61878
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Laboratories
City	Abbott Park
State	IL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
Code Info	Lot #: 11-122-DK, Exp 10/13
Classification	Class II
Reason for Recall	CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Product Quantity	121,000 vials
Recall Number	D-1388-2012

Class II Devices Event

Event ID	61913
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Spacelabs Healthcare, Llc
City	Issaquah
State	WA
Country	US
Distribution Pattern	Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM.

Associated Products

Product Description	The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
Code Info	Version 1.6.0.
Classification	Class II
Reason for Recall	The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.
Product Quantity	114
Recall Number	Z-1831-2012

Class II Drugs Event

Event ID	61917
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-May-12
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	Linde Gas LLC
City	Columbus
State	OH
Country	US
Distribution Pattern	Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.

Associated Products

Product Description	LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
Code Info	LOT#: 117H201 LOT#: 117H202
Classification	Class II
Reason for Recall	CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
Product Quantity	283 cylinders
Recall Number	D-1383-2012

Class II Devices Event

Event ID	61926
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BENIN BHUTAN BOLIVIA BOSNIA&HERZEGOVINA BRAZIL BRUNEI DARUSSALAM BULGARIA BURUNDI CAMBODIA CAMEROON CANARY ISLANDS CHAD CHILE CHINA COLOMBIA CONGO CONGO,DEMOCRATIC COSTA RICA COTE D'IVOIRE CROATIA CUBA CYPRUS CZECH REPUBLIC DENMARK DJIBOUTI DOMINICAN REPUBLIC ECUADOR EGYPT EL SALVADOR EQUATORIAL GUINEA ERITREA ESTONIA ETHIOPIA fake test ssd FINLAND FRANCE FRENCH GUIANA GABON GAMBIA GEORGIE GERMANY GHANA GREECE GUADELOUPE GUAM GUATEMALA GUINEA GUYANA HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKSTAN KENYA KUWAIT KYRGYZSTAN LAO PEOPLE'S DEM.REP LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRI LIECHTENSTEIN LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAWI MALAYSIA MALI MALTA MARTINIQUE MAURITANIA MAURITIUS METRACOM MEXICO MOLDOVA MONGOLIA MOROCCO MOZAMBIQUE NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORTH KOREA NORWAY OMAN PAKISTAN PALESTINE PANAMA PARAGUAY PERU PHC BEST PHILIPPINES PMCC BU Canada PMCC BU USA POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA&MONTE NEGRO SIERRA LEONE SINGAPORE SLOVAKIA SLOVENIA SOMALIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SUDAN SURINAME SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN TAJIKISTAN TANZANIA THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE Unidentified Country UNITED ARAB EMIRATES UNITED KINGDOM URUGUAY UZBEKISTAN VENEZUELA VIET NAM YEMEN ZAMBIA ZIMBABWE

Associated Products

Product Description	Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Code Info	Software release 2.0.2 and 2.0.2SP1 including mirror icon
Classification	Class II
Reason for Recall	With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "right patient side" marker, although this can appear on the left patient side
Product Quantity	752 units
Recall Number	Z-1818-2012

Class II Devices Event

Event ID	61935
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Boston Scientific Corporation
City	Marlborough
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland

Associated Products

Product Description	Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Code Info	Lot Numbers: 14951476, 14951479, 14987882,15068203
Classification	Class II
Reason for Recall	Difficulty in extending snare loop from the catheter
Product Quantity	2760 units
Recall Number	Z-1850-2012

Product Description	Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Code Info	Lot Numbers: 14951482, 14951484, 15068143
Classification	Class II
Reason for Recall	Difficulty in extending snare loop from the catheter
Product Quantity	1970 units
Recall Number	Z-1851-2012

Product Description	Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Code Info	Lot Number: 14974048
Classification	Class II
Reason for Recall	Difficulty in extending snare loop from the catheter
Product Quantity	1340 units
Recall Number	Z-1852-2012

Class II Devices Event

Event ID	61942
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Covidien LP
City	North Haven
State	CT
Country	US
Distribution Pattern	Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPAÑA France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK.

Associated Products

Product Description	Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code Info	LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
Classification	Class II
Reason for Recall	Potential for the sterility barrier to be compromised.
Product Quantity	50698 units
Recall Number	Z-1844-2012

Product Description	Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code Info	LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
Classification	Class II
Reason for Recall	Potential for the sterility barrier to be compromised.
Product Quantity	13531 units
Recall Number	Z-1845-2012

Product Description	Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code Info	LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
Classification	Class II
Reason for Recall	Potential for the sterility barrier to be compromised.
Product Quantity	13531 units
Recall Number	Z-1846-2012

Product Description	Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code Info	LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
Classification	Class II
Reason for Recall	Potential for the sterility barrier to be compromised.
Product Quantity	28248 units
Recall Number	Z-1847-2012

Product Description	Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Code Info	LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
Classification	Class II
Reason for Recall	Potential for the sterility barrier to be compromised.
Product Quantity	17848 units
Recall Number	Z-1848-2012

Class II Devices Event

Event ID	61946
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Natus Medical Incorporated
City	Seattle
State	WA
Country	US
Distribution Pattern	Worldwide Distribution -- USA (nationwide) including the states of : AK; AR; AZ; CA; CO; DE; FL; GA; HI; ID; IL; IN; KY; MA; MI; MN; MS; ND; NE; NJ; NY; OH; PA; SC; SD; TN; TX; and WA. and the countries of : Argentina; Australia; Austria; Canada; Egypt; Germany; Hong Kong; Indonesia; Iran; Italy; Kuwait; Poland; Russia; Saudi Arabia; Singapore; Slovenia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey; United Arab Emirates; and United Kingdom.

Associated Products

Product Description	Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "*OLYMPIC COOL-CAP Cooling UnitModel No.Made in USASoftware in this product is Natus Medical Incorporated**"
Code Info	Cooling Serial Numbers: 1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1030; 1031; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1080; 1081; 1082; 1083; 1085; 1086; 1087; 1088; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1101; 1116; 1117; 1118; 1119; 1120; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7013; 7014; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7265; 7266; 7267; 7268; 7269; 7270; 7271; 7272; 7273; 7274; 7275; 7276; 7277; 7278; 7279; 7280; 7281; 7282; 7283; 7284; 7285; 7286; 7288; 7289; 7290; 7291; 7292; 7293; 7294; 7363; 7364; 7365; 7366; 7372; and 7374.
Classification	Class II
Reason for Recall	Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
Product Quantity	181 units
Recall Number	Z-1843-2012

Class II Drugs Event

Event ID	61960
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-May-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Kutol Products Co Inc
City	Cincinnati
State	OH
Country	US
Distribution Pattern	IL

Associated Products

Product Description	Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
Code Info	Lot #: 090204012 , 090303026 , 090508009 , 090604024 , 090725030 , 090829002, 091005017 , 091223002 , 100115022 , 100316005 , 100115022 , 100316005,100329004 , 100607017 , 100730001 , 100817014 , 100921018 , 101020009, 101208003 , 101218007 , 110405009 , (L)11053105 , (L)11062811 , (L)11081805, and (L)11091206
Classification	Class II
Reason for Recall	Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.
Product Quantity	11,688 gallon bottles (2,922 cases)
Recall Number	D-1387-2012

Class II Food/Cosmetics Event

Event ID	61999
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ocean Group Inc.
City	Los Angeles
State	CA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Tiny IQF Oysters, 40pk/cs, 8oz.
Code Info	Lot#10997L
Classification	Class II
Reason for Recall	Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	187 units
Recall Number	F-1440-2012

Product Description	Large IQF Oysters, 6 x 4 lb/cs
Code Info	Lot#11801
Classification	Class II
Reason for Recall	Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	113 units
Recall Number	F-1441-2012

Product Description	Half Shell Oysters, 144pc/cs
Code Info	Lot#209003, 208497, 209628, 209683
Classification	Class II
Reason for Recall	Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	240 units
Recall Number	F-1442-2012

Class II Food/Cosmetics Event

Event ID	62019
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jun-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Kerry Foods
City	Beloit
State	WI
Country	US
Distribution Pattern	AZ, CA, MN, NV, NC, OR, IL, IN, MO, NE, OH, PA, TN, TX, WI. CANADA, CHILE

Associated Products

Product Description	KERRY, 4 CHEESE SEAS 30506103, CONTAINS MILK, Net Wt 50 Lb (22.68 Kg), Item Number 30506103.465
Code Info	0502206602
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	298 BG
Recall Number	F-1477-2012

Product Description	KERRY, WHITE CHEDDAR SNACK SEASONING, CONTAINS MILK, Item Number 6000654.01, Net Wt 50 Lb (22.68 Kg)
Code Info	0426260104
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	98 BG
Recall Number	F-1478-2012

Product Description	KERRY, CREAMY PARMESAN SEASONING, CONTAINS MILK, Item Number 62310.01, Net Wt 50 Lb (22.68 Kg)
Code Info	0426276401 -0426276404
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	401 CT
Recall Number	F-1479-2012

Product Description	KERRY, CHEDDAR CHEESE, CONTAINS MILK, 701183, R-SE-0056 , Item Number 701183.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0420276603
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	39 CT
Recall Number	F-1480-2012

Product Description	KERRY, NACHO SEAS 0686, Contains Milk, Wheat, Net Wt 22.68 KG (50 lb), Item Number 10686.482
Code Info	0412206603, 0503206601
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	810 BG
Recall Number	F-1481-2012

Product Description	KERRY, CHEESE BLEND 77, 1150020, CONTAINS MILK AND SOY, Item # 17980.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0503206602
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	40 BG
Recall Number	F-1482-2012

Product Description	KERRY, PARM. LING. 5734, SEA 5734, CONTAINS MILK, Item # 15734.607, , Net Wt 1000 Lb (453.556 Kg)
Code Info	0409258004
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	4.52 TT
Recall Number	F-1483-2012

Product Description	KERRY, LASAGNA SKLT SEAS 10078, SE10078, CONTAINS MILK, Item # I10078.859, Net Wt 1600 Lb (725.69Kg)
Code Info	0423205406
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	4 TT
Recall Number	F-1484-2012

Product Description	KERRY, CHEDDAR & SOUR CREAM 1037, CONTAINS MILK, Item # 717519.360, Net Wt 25 Lb (11.34Kg)
Code Info	0402276402 0402276403 0402276404 0502276401 0502276402 0502276403
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	957 BG
Recall Number	F-1485-2012

Product Description	KERRY, THREE CHEESE MINI SHELLS 10109, CH10109 , CONTAINS MILK, CH718592 Item Number I10109.859, Net Wt 1600 Lb (725.69 Kg)
Code Info	0417258001
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	7.647 TT
Recall Number	F-1486-2012

Product Description	KERRY, PARMESAN ASIAGO TYPE SEASONING, CONTAINS MILK, Item # 718622.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0509257903
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	41 BG
Recall Number	F-1487-2012

Product Description	KERRY, CHEDDAR & SOUR CREAM 725775, CONTAINS MILK, Item # 725775.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0423223803
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	41 BG
Recall Number	F-1488-2012

Product Description	KERRY, SOUR CR 7 CHIVES 718948, S37ASC, CONTAINS MILK, WHEAT, Item # 718948.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0430257902
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	145
Recall Number	F-1489-2012

Product Description	KERRY, THICK & CHEESY 0601, CH0601, CONTAINS MILK, Item Number 10601.859, Net Wt 1600 Lb (725.69 Kg)
Code Info	0424205403
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	5 TT
Recall Number	F-1490-2012

Product Description	Kerry, NO MSG CHED SC SEAS 01113, CONTAINS MILK, Item # 720061.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0511224104
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	41 BG
Recall Number	F-1491-2012

Product Description	Kerry, PARMESAN BLEND 720068 CH720068, CONTAINS MILK, WHEAT, Item # 720068.607, Net Wt 1000 Lb (453.556 Kg)
Code Info	0430258003
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	3 TT
Recall Number	F-1492-2012

Product Description	Kerry, CREAMY PARMESAN SEAS S57CP, CONTAINS MILK, WHEAT, Item # 720104.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0410257905
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	41 BG
Recall Number	F-1493-2012

Product Description	Kerry, CREAMY ITALIAN SEASONING S57CIT, CONTAINS MILK, Item # 720109.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0507257904
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	42 BG
Recall Number	F-1494-2012

Product Description	KERRY, CHEDDAR BROCCOLI SEAS S25CBROC, CONTAINS MILK, Item # 720175.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0504257903
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	41 TT
Recall Number	F-1495-2012

Product Description	KERRY, CREAMY GARLIC 720721 S25CG, CONTAINS MILK, SOY, WHEAT, Item # 720721.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0504257902
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	41 BG
Recall Number	F-1496-2012

Product Description	KERRY, PARM GARLIC 720850 R-SE-0152, CONTAINS MILK, Item # 720850.470, Net Wt 50 Lb (22.68 Kg)
Code Info	0510276401, 0426276602
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	120 CT
Recall Number	F-1497-2012

Product Description	KERRY, BACON 7 RANCH SEAS 720943 SE720943, CONTAINS MILK, SOY, WHEAT, Item # 720943.859, Net Wt 1600 Lb (725.69 Kg)
Code Info	0416258002 0504258001 0507258003
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	5.367 TT
Recall Number	F-1498-2012

Product Description	KERRY, STROGANOFF SEAS 10079 SE10079, CONTAINS MILK, WHEAT, Item # I10079.859, Net Wt 1600 Lb (725.69 Kg)
Code Info	0427205402
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	11 TT
Recall Number	F-1499-2012

Product Description	KERRY, NACHO SEAS NAT, CONTAINS MILK, Item # 721108.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0504224104
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	40 bg
Recall Number	F-1500-2012

Product Description	KERRY, WHITE CHEDDAR SEAS 10230 SE10230, CONTAINS MILK, WHEAT, Item # I10230.859, Net Wt 1600 Lb (725.69Kg)
Code Info	0426258001
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	4 TT
Recall Number	F-1501-2012

Product Description	KERRY, BUFFALO WING SEASONING , Item # I10256.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0507275301
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	100 BG
Recall Number	F-1502-2012

Product Description	KERRY, CULTURED NF BUTTERMILK 986, CODE 031001.010, CONTAINS MILK, Item # I2868.465 , Net Wt 50 Lb (22.68 Kg)
Code Info	0416205402 0417205401 0418205401
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	2400 BG
Recall Number	F-1503-2012

Product Description	KERRY, MELOBLEND 2237 code: d 1.29 edible, CONTAINS MILK, Item # I7097.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0418205403
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	44 BG
Recall Number	F-1504-2012

Product Description	KERRY, BUTTERMILK 987 CONTAINS MILK, Item # I2993.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0419205403
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	111 bg
Recall Number	F-1505-2012

Product Description	KERRY, AU GRATIN SEAS 722912, CONTAINS MILK, WHEAT, Item # 722912.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0502206603
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	200 bg
Recall Number	F-1506-2012

Product Description	KERRY, ONION RING SEAS 18125 , CONTAINS MILK, Item # B18125.01, Net Wt 50 Lb (22.68 Kg)
Code Info	0503224101
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	240 BG
Recall Number	F-1507-2012

Product Description	KERRY, STROGANOFF SEAS 722920 SE722920, CONTAINS MILK, WHEAT, Item # 722920.859, Net Wt 1600 Lb (725.69 Kg)
Code Info	0427205401
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	6 BG
Recall Number	F-1508-2012

Product Description	KERRY, MAC 7 CHS SAUCE MIX 723357 CH723357, CONTAINS MILK, WHEAT, Item # 723357.859, Net Wt 1600 Lb (725.69 Kg)
Code Info	0410258001 0416258001
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	40 TT
Recall Number	F-1509-2012

Product Description	KERRY, BACON RANCH SEAS 723951 S57RB, CONTAINS MILK, Item # 723951.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0410257904 0508257901
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	112 BG
Recall Number	F-1510-2012

Product Description	KERRY, SALSA FRESCA 725058, Item # 725058.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0426276601
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	40 BG
Recall Number	F-1511-2012

Product Description	KERRY, ITALIAN PASTA SALAD SEASONING, Item # 725445.859, Net Wt 1600 Lb (725.69 Kg)
Code Info	0430258002
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	10 TT
Recall Number	F-1512-2012

Product Description	KERRY, GOLDEN CHEDDAR CHEESE 716932 , R-SE-0132, CONTAINS MILK, Item # 716932.465, Net Wt 50 Lb (22.68Kg) KERRY, R-SE-0132TM, CONTAINS MILK, Item # 716932.TM, Net Wt 50 Lb (22.68Kg)
Code Info	0510276403 0424276403
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	178 CT
Recall Number	F-1513-2012

Product Description	KERRY, SEA SALT & VINEGAR 722536 R-SE-0155, , Item # 722536.440, Net Wt 40 Lb (18.14 Kg) KERRY, R-SE-0155TM, , Item # 722536.TM, Net Wt 40 Lb (18.14 Kg)
Code Info	0420276401 0420276402 0420276403 0426275303 0426275302
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	400 CT
Recall Number	F-1514-2012

Product Description	KERRY, MOZZARELLA SESONING - NO PHSO, CONTAINS MILK, SOY, Item # I10187.465 , Net Wt 50 Lb (22.68Kg)
Code Info	0502224108
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	82.000 BG
Recall Number	F-1515-2012

Product Description	KERRY, ROASTED GARLIC SEAS 10112, S37RG2 , CONTAINS MILK, SOY, Item # I10112.465, Net Wt 50 Lb (22.68Kg)
Code Info	0410206604
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	362.000 BG
Recall Number	F-1516-2012

Product Description	KERRY, DOUBLE CHEESEBURGER SEAS 8917 , S20DC, CONTAINS MILK, WHEAT, Item #I8917.465, Net Wt 50 Lb (22.68Kg)
Code Info	0417258002
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	164.000 BG
Recall Number	F-1517-2012

Product Description	KERRY, SOUR CRM & CHIVES 0989 S37SCC, CONTAINS MILK, , Item #I0989.465 , Net Wt 50 Lb (22.68Kg)
Code Info	0510257902
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	106.000 BG
Recall Number	F-1518-2012

Product Description	KERRY, CHEESEBURGER SEAS 8543, S20C3, CONTAINS MILK,WHEAT , Item #I8543.465 , Net Wt 50 Lb (22.68Kg)
Code Info	0430205403
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	408.000 BG
Recall Number	F-1519-2012

Product Description	KERRY, KF PART # 117404 , CONTAINS MILK, Item #I10389.02 , Net Wt 50 Lb (22.68Kg)
Code Info	0426223810 0420223803
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	327 BG
Recall Number	F-1520-2012

Product Description	KERRY, KF # 11605R, CONTAINS MILK, Item #B18648.02 , Net Wt 50 Lb (22.68Kg)
Code Info	0502224105
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	80.000 BG
Recall Number	F-1521-2012

Product Description	KERRY, KF # 10987R, CONTAINS MILK, Item #B16903.01, Net Wt 50 Lb (22.68Kg)
Code Info	0509224102
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	40 BG
Recall Number	F-1522-2012

Product Description	KERRY, CHEDDAR BEER TYPE 725554 , CONTAINS MILK, Item #725554.465, Net Wt 50 Lb (22.68Kg)
Code Info	0423223802
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	40 BG
Recall Number	F-1523-2012

Product Description	KERRY, BATTER G3668, 1520374, CONTAINS MILK AND WHEAT, Item #G3668.MC1, Net Wt 50 Lb (22.68Kg)
Code Info	0404216007
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	36.000 BG
Recall Number	F-1524-2012

Product Description	KERRY, HOT CHEESE, SEAS, 04-20200, CONTAINS MILK , Item #I10185.465, Net Wt 50 Lb (22.68Kg)
Code Info	0426258003
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	35 CT
Recall Number	F-1525-2012

Product Description	KERRY, NACHO SEASONING 717379, 04-20200, CONTAINS MILK , SOY, Item # 717379.465, Net Wt 50 Lb (22.68Kg)
Code Info	0425260117
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	394 BG
Recall Number	F-1526-2012

Product Description	KERRY, CHEESE BLEND 862B , CONTAINS MILK Item # I2065.465, Net Wt 50 Lb (22.68Kg)
Code Info	0426257901
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	42 BG
Recall Number	F-1527-2012

Product Description	KERRY, CHEESE SEASONING 15704, CONTAINS MILK, Item # B15704.01, Net Wt 50 Lb (22.68Kg)
Code Info	0504224103 0504224102
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	493 BG
Recall Number	F-1528-2012

Product Description	KERRY, CHEESY CHEDDAR SEAS I10103, CONTAINS MILK, SOY, Item # I10103.465, Net Wt 50 Lb (22.68Kg)
Code Info	0511223806
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	238 BG
Recall Number	F-1529-2012

Product Description	KERRY, JALAPENO CHEDDAR 16975, GCAS# 95546689, CONTAINS MILK, Item # B16975.01, Net Wt 50 Lb (22.68Kg)
Code Info	0430223802 0430223803
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	391 BG
Recall Number	F-1530-2012

Product Description	KERRY, CHEZ-TONE 6313, QO-05424 / QO-2200542400, CONTAINS MILK, Item # I6313.465, Net Wt 50 Lb (22.68Kg)
Code Info	0410206601
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	401 BG
Recall Number	F-1531-2012

Product Description	KERRY, MELOBLEND 737, CODE:QO-05358, CONTAINS MILK, Item # I7126.465, Net Wt 50 Lb (22.68Kg)
Code Info	0416205401
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	400 BG
Recall Number	F-1532-2012

Product Description	KERRY, PL BROC & CHEESE SEAS 8893 , CONTAINS MILK, WHEAT, Item # I8893.465, Net Wt 50 Lb (22.68Kg)
Code Info	0419258001
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	204 BG
Recall Number	F-1533-2012

Product Description	KERRY, MELOBLEND 1048, 95317, CONTAINS MILK, Item # I7067.465, Net Wt 50 Lb (22.68Kg)
Code Info	0420205403
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	896 BG
Recall Number	F-1534-2012

Product Description	KERRY, PARMESAN AND SUNDRIED TOMATO SEASONING, CONTAINS MILK, Item # B18122.01, Net Wt 50 Lb (22.68Kg)
Code Info	0508276601
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	40 BG
Recall Number	F-1535-2012

Product Description	KERRY, HOT BUFFALO WINGS PRETZEL SEAS 173211, Item # B16413.01, Net Wt 44.5 Lb (20.18 kg)
Code Info	0424223803 0424223804 0502223801 0502223802
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	1309 BG
Recall Number	F-1536-2012

Product Description	KERRY, SOUR CREAM AND ONION 10286, CONTAINS MILK, Item # I10286.465, Net Wt 50 Lb (22.68 Kg)
Code Info	0430275306 0430275307 0430275304 0430275305 0430275308 0430275301 0430275302
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	560 BG
Recall Number	F-1537-2012

Product Description	KERRY, PARM GARLIC SEAS 721221, CONTAINS MILK, Item # 721221.399 & 721221.398 , Net Wt 50 Lb (22.68 Kg)
Code Info	0426223807
Classification	Class II
Reason for Recall	Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with metal fragments.
Product Quantity	60 BG
Recall Number	F-1538-2012

Class II Devices Event

Event ID	62052
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Australia Austria Belgium Bharain Canada China Columbia Czech Republic Denmark Dutch Antilles Egypt Estonia Finland France Germany Hong Kong Ireland Israel Italy Latvia Lebanon Luxembourg Malaysia Mexico Netherlands New Zealand Norway Philippines Qatar Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom

Associated Products

Product Description	Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography
Code Info	Units with cable swivel delivered from 2007
Classification	Class II
Reason for Recall	MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
Product Quantity	433 units
Recall Number	Z-1829-2012

Class II Devices Event

Event ID	62120
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ultradent Products, Inc.
City	South Jordan
State	UT
Country	US
Distribution Pattern	Worldwide Distribution.

Associated Products

Product Description	Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
Code Info	Lot number: B6Z4K.
Classification	Class II
Reason for Recall	Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.
Product Quantity	172 kits (4 syringes per kit)
Recall Number	Z-1822-2012

Class II Devices Event

Event ID	62125
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Arrow International Inc
City	Reading
State	PA
Country	US
Distribution Pattern	USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.

Associated Products

Product Description	Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
Code Info	Lot number RF2033361
Classification	Class II
Reason for Recall	Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
Product Quantity	1,085
Recall Number	Z-1823-2012

Class II Devices Event

Event ID	62127
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Genzyme Corporation
City	Framingham
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - US (nationwide) and the country of S. Korea

Associated Products

Product Description	seprafilm® Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Code Info	Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
Classification	Class II
Reason for Recall	Sterility of product may be compromised due to packaging defect
Product Quantity	3880units
Recall Number	Z-1855-2012

Product Description	seprafilm® Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Code Info	Lot number: 11NP685 . Exp 2014- 11
Classification	Class II
Reason for Recall	Sterility of product may be compromised due to packaging defect
Product Quantity	1285 units
Recall Number	Z-1856-2012

Class II Devices Event

Event ID	62130
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Dec-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Stryker Howmedica Osteonics Corp.
City	Mahwah
State	NJ
Country	US
Distribution Pattern	Nationwide Distribution

Associated Products

Product Description	Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.
Code Info	510K exempt Catalog Number 1020-1400 Lot Code P5E93
Classification	Class II
Reason for Recall	Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Product Quantity	41 units
Recall Number	Z-1816-2012

Class II Drugs Event

Event ID	62239
Status	Completed
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Feb-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Physicians Total Care, Inc.
City	Tulsa
State	OK
Country	US
Distribution Pattern	AK, NC, GA

Associated Products

Product Description	Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0
Code Info	Lots 6284, 60DI, 61AA.
Classification	Class II
Reason for Recall	Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
Product Quantity	3 bottles
Recall Number	D-1389-2012

Class II Food/Cosmetics Event

Event ID	62273
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Jun-12
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Woosung America Corp.
City	Hayward
State	CA
Country	US
Distribution Pattern	Northern CA only.

Associated Products

Product Description	Frozen Oysters: 1) CHORIPDONG) FROZEN OYSTER, IQF 8OZ40; 2) CJ FOOD, INC.)FROZEN OYSTER 8oz40; Not for Retail Sale, Must be fully cooked before serving. Distributed by CJ Foods, Inc., Commerce, CA; 3) JAYONE FOODS, INC.) FROZEN OYSTER 8 oz*40, IQF, Distributed by Jayone Foods, Inc.., Paramount, CA 92723 Product of Korea
Code Info	1) Item number 3137810; 2) Item number 2237840; 3) Item number 36037800
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	not provided
Recall Number	F-1444-2012

Product Description	HONG CHANG)OYSTER MEAT 8 oz*40
Code Info	Item number 2137845
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	not provided
Recall Number	F-1445-2012

Product Description	NARAE) SEASONED SALTED FERMENTED CLAM 44lb; Salted Comb Pen Shell Imported by Woosung America Corp, Haw yard, CA 94545
Code Info	Item number 3735615
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	not provided
Recall Number	F-1446-2012

Product Description	NARAE) SALTED FERMENTED CLAM 44lb Imported by Woosung America Corp, Hayward, CA 94545
Code Info	Item number 3735620
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	not provided
Recall Number	F-1447-2012

Product Description	OCEAN GREEN)OYSTER LARGE 5lb*6, IQF Imported by: J & S Group 2535E 12th St. #B Los Angeles, CA 90021
Code Info	Item number oys0070
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	not provided
Recall Number	F-1448-2012

Product Description	PACIFIC GIANT) OYSTERS,IQF,KOREA 8 oz*40 Imported by Pacific Giant, Vernon, CA 90058 Product of Korea
Code Info	Item number 6537880
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	not provided
Recall Number	F-1449-2012

Class II Food/Cosmetics Event

Event ID	62275
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Sonora Mills Foods
City	East Rancho Dominguez
State	CA
Country	US
Distribution Pattern	US Nationwide and Canada

Associated Products

Product Description	popchips® Cheddar Potato, Popped Chip Snack, 0.8 oz, UPC 0 82666 78800 3
Code Info	Lot MAY2613, MAY2913TM
Classification	Class II
Reason for Recall	The firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments.
Product Quantity	567 cases
Recall Number	F-1631-2012

Product Description	popchips® Sea Salt & Vinegar, Potato Popped Chip Snack, 0.4 oz (UPC 0 82666 76550 9), 0.8 oz (UPC 0 82666 75500 5), 3 oz (UPC 0 82666 70050 0), 85 g (UPC 0 82666 71240 4 and 0 82666 71240 4)
Code Info	0.4oz: MAY2113; 0.8 oz: Lot MAY1613, MAY2013, MAY2113TM, MAY2613; 3 oz: MAY0313, MAY0813, MAY0913, MAY1013LY, MAY1513, MAY1613, MAY2113, MAY2113TM; 85g: Lot 13MA23TM and 13MA08
Classification	Class II
Reason for Recall	The firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments.
Product Quantity	17586 cases
Recall Number	F-1632-2012

Product Description	Cheddar Mini Rice Snacks under the following brand names: Fred Meyer, 3 oz, UPC 0 11110 90004 3; Kroger, 3 oz, UPC 0 11110 35789 2; Ralphs, 3 oz, UPC 0 11110 91220 9; Safeway, 3 oz. UPC 0 21130 29808 2;
Code Info	Lot FEB 19 13
Classification	Class II
Reason for Recall	The firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments.
Product Quantity	2395 cases
Recall Number	F-1633-2012

Class II Food/Cosmetics Event

Event ID	62303
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	True World Foods San Francisco LLC.
City	San Leandro
State	CA
Country	US
Distribution Pattern	Restaurants in Northern Ca only.

Associated Products

Product Description	Oyster Frozen Half Shell; 144 Pc/CS Processed by: Dai One Food Co., LTD #150 Jun-RI, Sanyang-UP Tongyeong-City Kyungsangnam-DO. to: Khee Trading, Vernon, CA 90058.
Code Info	Code number OYS0300
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	not provided
Recall Number	F-1437-2012

Product Description	Frozen Oyster Meat IQF (Z4) 4 lb box Packed by Dong Won Mul San Co. Tongyeong-City, Gyeongsangnam-Do. Imported by Ayana Group, Inc. Washington, CA
Code Info	Code number OYS0550
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	not provided
Recall Number	F-1438-2012

Product Description	Breaded Oyster Large Size
Code Info	Code number OYS0800
Classification	Class II
Reason for Recall	The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity
Recall Number	F-1439-2012

Class II Food/Cosmetics Event

Event ID	62339
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Red Chamber Company
City	Vernon
State	CA
Country	US
Distribution Pattern	California and Floria

Associated Products

Product Description	Frozen Korean Oyster Meat I.Q.F.: , 1) 40x8oz., UPC 19964 30091; 2) 1x25lbs, .; 3) 5x4lbs.UPC 19964 30092
Code Info	1) lot#138338P; 2) lot#138339-P; 3) lot #138340-P
Classification	Class II
Reason for Recall	Red Chambers is recalling Dai One Food Oyster IQF 4lbs, 25 lbs, and 8 oz because the products have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	1) 83 units; 2) 800 units; 3) 13 units
Recall Number	F-1542-2012

Class III Devices Event

Event ID	61737
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Tripath Imaging, Inc.
City	Burlington
State	NC
Country	US
Distribution Pattern	Worldwide Distribution.

Associated Products

Product Description	PrepStain Syringing Pipettes 240 (Catalog #490517)
Code Info	100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r
Classification	Class III
Reason for Recall	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity	46,112,784 for all products in Recall Event
Recall Number	Z-1811-2012

Product Description	PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Code Info	100903ra, 100903rb, 100903rf, 100903rj, 100903rn, 100903rr, 100903rt, 100903rx, 100903sb, 100903sc, 100903sd, 100903se, 100903sf, 100903sl, 100910rd, 100910re, 100910rh, 100910rp, 100910rq, 100910rr, 100917rb, 100917rh, 100917rk, 100917rp, 100917rr, 100917ru, 100917sa, 100917sc, 100917se, 100924ra, 100924ri, 100924rj, 100924rl, 100924rn, 100924rp, 100924rs, 100924rt, 100924ry, 101001ra, 101001rb, 101001rc, 101001rh, 101001rm, 101001rq, 101001ru, 101001rv, 101001rw, 101001ry, 101001rz, 101008ra, 101008rb, 101008rf, 101008rg, 101008rh, 101008ri, 101008rq, 101008rr, 101008rw, 101008rx, 101008sa, 101008sc, 101008sd, 101008se, 101008sf, 101008sg, 101008sh, 101015rh, 101015rk, 101015rr, 101015rw, 101015rx, 101015sd, 101015se, 101015sf, 101015sg, 101022re, 101022rp, 101022rq, 101022sb, 101022si, 101022sk, 101022sl, 101022so, 101022sr, 101022su, 101029ra, 101029rd, 101029re, 101029rh, 101029ri, 101029rx, 101029sc, 101029sd, 101029sf, 101029sk, 101029ss, 101029st, 101105rl, 101105rm, 101105rt, 101105sb, 101105sd, 101105se, 101105sf, 101105sk, 101105sl, 101105so, 101105ss, 101112ra, 101112re, 101112rl, 101112rt, 101112ru, 101112rv, 101112rz, 101112sa, 101112sf, 101112sg, 101112si, 101112sw, 101112sx, 101119ra, 101119ri, 101119rj, 101119rr, 101119ru, 101119rx, 101119ry, 101119rz, 101119sh, 101119sl, 101119so, 101126ra, 101126rg, 101126rl, 101203ra, 101203rb, 101203rc, 101203rd, 101203rh, 101203rj, 101203rp, 101203rr, 101203rs, 101203ru, 101203rw, 101203si, 101203sl, 101203sn, 101203so, 101203sp, 101210rg, 101210rh, 101210rk, 101210rl, 101210ru, 101210rv, 101210rx, 101210sa, 101210sj, 101217ra, 101217rc, 101217rh, 101217rm, 101217rn, 101217rp, 101217rt, 101217rw, 101217rx, 101224rd, 101224re, 101224rg, 101224rk, 101224rl, 101224rt, 101224ru, 101224rv, 101224rw, 101231rc, 101231rd, 101231rg, 101231rh, 101231ri, 101231rj, 101231ro, 101231rp, 110107rh, 110107ri, 110107rk, 110107rp, 110107rq, 110107rr, 110107rz, 110107sb, 110107sc, 110114rf, 110114rg, 110114rv, 110114rw, 110114rx, 110114ry, 110114sj, 110114sk, 110114sm, 110121rd, 110121rn, 110121rq, 110128rd, 110128rp, 110128rq, 110128rx, 110128sb, 110128sc, 110128sg, 110128sl, 110128sn, 110128sp, 110128sq, 110204ra, 110204rd, 110204rg, 110204rj, 110204rq, 110204rv, 110204rx, 110204sd, 110211rb, 110211rd, 110211rg, 110211rj, 110211rn, 110218rw, 110225rk, 110225rl, 100917rc, 101015sb, 101119sg, 101217ro, 110114sc, 110128sk
Classification	Class III
Reason for Recall	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity	46,112,784 for all products in Recall Event
Recall Number	Z-1812-2012

Product Description	PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
Code Info	100917ry, 101105sh, 110107rg
Classification	Class III
Reason for Recall	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity	46,112,784 for all products in Recall Event
Recall Number	Z-1813-2012

Product Description	Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Code Info	100903ru, 100924rr, 101022sc, 110114sh, 110225ru
Classification	Class III
Reason for Recall	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity	46,112,784 for all products in Recall Event
Recall Number	Z-1814-2012

Product Description	PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
Code Info	This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r
Classification	Class III
Reason for Recall	The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
Product Quantity	46,112,784 for all products in Recall Event
Recall Number	Z-1815-2012

Class III Drugs Event

Event ID	61759
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Teva Pharmaceuticals USA, Inc.
City	Sellersville
State	PA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Code Info	Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013
Classification	Class III
Reason for Recall	Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Product Quantity	40,750 Dispensers
Recall Number	D-1384-2012

Class III Food/Cosmetics Event

Event ID	61937
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-May-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	LA Link Corporation
City	Cerritos
State	CA
Country	US
Distribution Pattern	Distributed to retail in the following states: HI, NV, CA

Associated Products

Product Description	Shiitake-Ya brand Dried Shiitake mushroom slices, 6 oz plastic jars, UPC 7 1452 22183 9. Product labeling reads in part: " Shiitake-Ya gourmet Shiitake SLICES*Antioxidants Amino Acids Omega 3+6Immune-Boosting NET WEIGHT. 6 oz (170 g)*Natural Enzymes Fiber (80% Chitin) Iron Kojic Acid
Code Info	Item # 26211, Sell by 041613
Classification	Class III
Reason for Recall	Shiitake-Ya Gourmet Shiitake slices are being recalled because FDA test analysis showed presence of pesticide and polycyclic aromatic hydrocarbon residues: 0.208 ppm carbendazim, 0.072 ppm Fluoranthene and 0.092 ppm Pyrene. There are no tolerances for any of these pesticide residues.
Product Quantity	27,648 jars
Recall Number	F-1634-2012

Class III Drugs Event

Event ID	62053
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hospira, Inc.
City	Lake Forest
State	IL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
Code Info	Lot #: 04510KL, Exp 01OCT2012; lot number may have 01 or 02 following it
Classification	Class III
Reason for Recall	Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Product Quantity	164,568 containers
Recall Number	D-1390-2012

Class III Food/Cosmetics Event

Event ID	62276
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	World Finer Foods, Inc.
City	Bloomfield
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Reese Colossal Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00576
Code Info	UPC 70670-00576; OYSO MY-7 1520; OYSO MY-7 1521; OYSO My-7 1617; OYSO MY-7 1618; OYSO MY-7 1620.
Classification	Class III
Reason for Recall	According to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus.
Product Quantity	2350 cases
Recall Number	F-1450-2012

Product Description	Reese Medium Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00600.
Code Info	UPC 70670-00600; OYSO MY-7 1523; OYSO MY-7 1521; OYSO My-7 1618; OYSO; OYSO MY-7 1621.
Classification	Class III
Reason for Recall	According to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus.
Product Quantity	900 cases
Recall Number	F-1451-2012

Product Description	Reese Petite Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea, UPC 70670-00575.
Code Info	UPC 70670-00575; OYSO SY-7 1524; OYSO SY-7 1521; OYSO SY-7 1617; OYSO SY-7 1621.
Classification	Class III
Reason for Recall	According to information published by the FDA: Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus.
Product Quantity	950 cases
Recall Number	F-1452-2012

Class III Food/Cosmetics Event

Event ID	62285
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Camerican International
City	Paramus
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Smoked Oysters In cottonseed oil sold under the following brand names: 1) Fredmeyer Smoked Oysters In cottonseed oil Net Wt 3.75 oz (106 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Ralph's Smoked Oysters In Cottonseed Oil Distributed by Inter-American Products Cincinnati, Ohio 45202 Product of Korea; 3) Kroger Smoked Oysters In cottonseed oil , Distributed by the Kroger Co., Cincinnati, OH 45202, Product of Korea
Code Info	All lots and UPCs Best by date 2013
Classification	Class III
Reason for Recall	Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus.
Product Quantity	1) 4600 units; 2) 7112 units; 3) 63,884 units
Recall Number	F-1454-2012

Product Description	Whole Oysters in Water under the following brand names: 1) Ralph's Whole Oysters in Water, Net Wt. 8 OZ (226 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Kroger Whole Oysters in Water Net Wt. 8 OZ (226g) Distributed by the Kroger Co., Cincinnati, Ohio 45202
Code Info	All lots and UPCs
Classification	Class III
Reason for Recall	Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus.
Product Quantity	1) 2709 units; 2) 17,715 units
Recall Number	F-1455-2012

Product Description	Northern Catch Fancy Whole Oysters Net Wt. 8 OZ (227g) Distributed by the Aldi Inc., Batavia, IL 60510 Product of Korea
Code Info	OBYL MY7 0427, OBYL MY7 0503, OBYL MY7 0507, OBYL MY7 0512, OBYL MY7 0515, OBYL MY7 0518, OBYL MY7 0519, OBYL MY7 0521, OBYL MY7 0524, OBYL MY39 0505, OBYL MY39 0506, OBYL MY39 0511, OBYL MY39 0513, OBYL SY7 0422, OBYL SY7 0429, OBYL SY7 0521, OBYL SY7 0524, OBYL SY7 0525, OBYL SY39 0510, OBYL SY39 0512, OBYL TY7 0426, OBYL TY7 0427, OBYL TY7 0501, OBYL TY7 0521
Classification	Class III
Reason for Recall	Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus.
Product Quantity	95000 units
Recall Number	F-1456-2012

Class III Food/Cosmetics Event

Event ID	62312
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jun-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	King Seafoods Inc.
City	Columbus
State	NJ
Country	US
Distribution Pattern	North Carolina, South Carolina and Tennessee

Associated Products

Product Description	Granadaisa whole Oysters, Net WT. 8 oz (225 grams); Packed For King Seafoods Inc. PO BOX 107, Mount Holly, NJ USA 08060 Product of Korea Farm Raised, UPC 719882002049.
Code Info	no coding
Classification	Class III
Reason for Recall	The US FDA has removed all Korean certified shippers of molluscan shellfish (oysters, clams, mussels and scallops) from the Interstate Shellfish Shippers List (ICSSL), following a comprehensive FDA evaluation that determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls spelled out under the National Shellfish Sanitation Program.
Product Quantity
Recall Number	F-1460-2012

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