Tag Archives: Recall

ConAgra Foods Recalls Frozen Chicken and Beef Products Due to Possible Foreign Matter Contamination

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ConAgra-3 ConAgra Foods, a Russellville, Ark. establishment, is recalling approximately 3,806 pounds of frozen chicken and beef entrée products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The metal fragments range in size between 2 and 9 millimeters (mm) in diameter, and are curled, malleable and shiny. The metal fragments may be embedded in the sauce contained within the frozen entrée products.

The frozen chicken and beef entrée items were produced on June 13, 2016 and June 22, 2016. The following products are subject to recall: [View Labels (PDF only)]

* 22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Brand Signature Spicy Chicken.” with “Use By” date of 6/08/17 and case code 5006616500.
* 22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Brand Mongolian Style Beef.” with “Use By” date of 6/17/17 and case code 5006617400.

The products subject to recall bear establishment number “EST. 233” or “EST. P-115” inside the USDA mark of inspection. These items were shipped to distributors and retail locations in Arkansas, Illinois, Michigan, Minnesota, New York, Vermont, and Wisconsin.

The problem was discovered July 1, 2016, when an establishment employee observed metal fragments while dispensing sugar from a supplier for sauce formulation during processing. The resulting sauce is a component in the frozen entrée products.

There have been no confirmed reports of adverse reactions or injuries due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Exceptional Health Products Issues Allergy Alert On Undeclared Soy And Milk Allergens In Angel Wings™- Daily Multi 120 Capsules

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ucm497171Exceptional Health Products of Tulsa Oklahoma is recalling Angel Wings™ – Daily Multi 120 Capsules because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

The following product was distributed nationwide to consumers through mailorder.

Product Name: Angel Wings™ – Daily Multi 120 Capsules

Lot Numbers: 14656, 14657, 15109, 15489, 15488, 15616, and 16007

This voluntary recall has been initiated because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

No illnesses have been reported to date. This was brought to our attention by the Food and Drug Administration that found inconsistencies with our supplier’s allergen statement on the Amino Acid ingredients used in this formulation.

The recalled lot numbers began shipping nationwide on December 23, 2014. If you find the recalled lot numbers on the bottom of any bottle you have inventory you may return it to the address at the bottom for a full refund or replacement. If you have further distributed this product, please identify the recipients or your customers and notify them at once of this product recall.

If you have any questions, call 888-548-0477 Monday thru Friday 8:00 AM to 5:00 PM CST. We are sorry for this inconvience and appreciate your assistance.

Voluntary Recall of Fetch™ 2 Aspiration Catheter

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MARLBOROUGH, Mass. – Boston Scientific (NYSE: BSX) has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. The U.S. Food and Drug Administration (FDA) classified the action as a Class 1 recall. This recall designation means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.

There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter. All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications. While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically.

As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to this recall.

Fetch 2 Catheter UPNs
FETCH2 US
109400-001
FETCH2 OUS
109400-002
FETCH2 Canada
109400-003
FETCH2 Japan
109400-004
FETCH2 EU
109400-005

Physicians and healthcare facilities can direct questions to their Boston Scientific representative or, call 1-800-811-3211. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
    or
  • Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to Boston Scientific by calling 1-800-811-3211 and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Vascular Solutions, Inc. Issues Recall of Guardian® II Hemostasis Valves

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On March 3, 2016, Vascular Solutions, Inc. (Nasdaq: VASC), initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. This recall only affects the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves. No injuries have been reported in association with this issue to date.

Healthcare facilities that have the affected Guardian II hemostasis valves should remove the products from their inventory and return them to Vascular Solutions.

The recalled products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016.

The recalled products are specific lots of Model Numbers 8210 and 8211. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 26,550 devices have been manufactured, with 5,283 distributed in the United States. The condition that led to the recall may affect approximately 2.4% of recalled devices.

Vascular Solutions Inc. voluntarily initiated the recall on March 3, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific lots subject to the recall and included instructions on how to return the affected products.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program:

For further information, connect to www.vasc.com.

Progressive Gourment Inc. Issues an Allergy Alert on Taste of Inspirations Edamame Rangoon

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ucm495082Progressive Gourmet Inc. of Wilmington, MA, is voluntarily recalling its frozen, 9 ounce packages of Taste of Inspirations Edamame Rangoon out of an abundance of caution because they have the potential to contain crustacean shellfish (crab). People who have an allergy to crustacean shellfish run the risk of serious or life-threatening allergic reaction if they consume these products. The item is produced for Hannaford Supermarkets.

The product comes in a 9 ounce carton, marked with Best Before: 1 1117 on the back of the retail carton. Note, no other production runs of this product are impacted by this recall.

The potentially impacted Edamame Rangoon were possibly sold to consumers at select Hannaford stores located in Maine, Massachusetts, New Hampshire, Vermont and New York.

A consumer reported the mislabeling incident. The firm has initiated prompt corrective actions to prevent future mislabeling. No illnesses have been reported to date in connection with this product.

Consumers who have purchased 9 ounce packages of the edamame rangoon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-224-7630 (9:00 am – 5:00 pm Monday through Friday EST).

Pilgrim’s Pride Corp. Recalls Poultry Products Due To Possible Foreign Matter Contamination

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Class I recall is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

WASHINGTON — Pilgrim’s Pride Corp., a Waco, Texas establishment, is recalling approximately 40,780 pounds of fully cooked chicken nugget products that may be contaminated with extraneous plastic materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The fully cooked chicken nugget products were produced on Oct. 5, 2015. The following products are subject to recall: [Label (PDF Only)]

20-lb. cardboard boxes containing two, 10-lb. clear plastic bags of fully cooked chicken nuggets labeled as “GOLD KIST FARMS Fully Cooked Whole Grain Popcorn Style Chicken Patty Fritters.”

The products subject to recall bear establishment number “EST. P-20728” inside the USDA mark of inspection and include package codes 5278105021, 5278105022, 5278105023, 5278105000, and 5278105001. These items were shipped for institutional use to Arizona, California, Colorado, Florida, Georgia, Kansas, Kentucky, North Carolina, Nebraska, Oklahoma, Tennessee, Texas, and Utah.

The problem was discovered after the firm received several consumer complaints regarding plastic contamination of the chicken nuggets. The firm notified FSIS personnel of the issue on April 6, 2016.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Namias of Arizona Recalls Chicken Products Due To Misbranding and Undeclared Allergens

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Namias of Arizona, Inc., a Tucson, Ariz. establishment, is recalling approximately 19,200 pounds of chicken products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain hydrolyzed soy protein, a known allergen which is not declared on the product label.

The fully-cooked chicken items were produced on various dates between Sept. 2, 2015, and March 1, 2016. The following products are subject to recall:

  • 20-pound cases containing 5-pound bags of “Carlotta’s Kitchen CHICKEN CHILE VERDE.”
  • 20-pound cases containing 5-pound bags of “Carlotta’s Kitchen SPORTS CHICKEN,” a chili-type entree.

The products subject to recall bear establishment number “P-6006” inside the USDA mark of inspection. The chicken chile verde items were shipped to the company’s restaurant in Nevada. The sports chicken items were shipped to the company’s restaurants in Arizona.

The problem was discovered by FSIS personnel during a routine label review at the establishment. Hydrolyzed soy is a component of the chicken base used to manufacture the products.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumers and media with questions about the recall can contact Garret Boos, company operations manager, at (520) 903-1922.

McCain Foods USA, Inc. Recalls Pork Products Due To Possible Foreign Matter Contamination

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McCain Foods USA, Inc., a Lisle, Ill. establishment, is recalling approximately 25,215 pounds of bacon fritters that may be contaminated with extraneous plastic materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The potato, egg, cheese, and bacon fritters were produced on Nov. 11, 2015. The following products are subject to recall:

1,681 cases bearing a batch code 1001487402 containing four 3.75-lb. plastic vacuum-packed packages containing “McCain EARLY RISERS Potato, Egg, Cheese & Bacon Fritters.”

The products subject to recall bear establishment number “EST. 18846” inside the USDA mark of inspection. These items were shipped to food service distributors in Arkansas, Florida, Iowa, Indiana, Illinois, Kansas, Maine, Oklahoma, Ohio, Texas, Tennessee, and Utah.

The problem was discovered after the firm received a consumer complaint and subsequently notified an in-plant FSIS inspector.

There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Whole Foods Recalls Frozen Pizza Products Due to Misbranding

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Whole Foods/North Atlantic Kitchens, an Everett, Mass. establishment, is recalling approximately 73,898 pounds of pepperoni pizza products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product is labeled as containing uncured beef pepperoni. However, the pizzas contain uncured pork pepperoni, which is not declared on the product label. Some individuals have a sensitivity or intolerance to pork.

The fresh pizza items were produced Jan. 5, 2015, through Jan. 22, 2016.
pizza

  • 10-oz. vacuum-sealed packages of “WHOLE FOODS MARKETS, PIZZA, PEPPERONI, 8”.
  • 19-oz. vacuum-sealed packages of “WHOLE FOODS MARKETS, PIZZA, PEPPERONI, 12”.

The products subject to recall bear establishment number “EST. 20234” inside the USDA mark of inspection and Sell-by dates of Jan. 12, 2015 through Jan. 30, 2016 printed on the packaging. These items were shipped for wholesale and retail sale in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, and Rhode Island.

The problem was discovered by FSIS during a label review at the establishment and occurred as a result of a change in ingredient suppliers.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Berks Packing Co. Recalls Beef Products Due to Misbranding

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Berks Packing Co., a Reading, Pa. establishment, is recalling approximately 1,320 pounds of beef products that may be misbranded, and may contain pork and erythorbate, an additive, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The beef knockwurst links were produced on Nov. 12, 2015.
Berks-2

Berks-1
>> 1-lb. (plastic shrink wrapped) packages containing links of “BERKS Heat & Serve Knockwurst.” The packages have a sell by date of March 11, 2016 printed on the package.

The products subject to recall bear establishment number “EST. 8782” inside the USDA mark of inspection. These items were shipped to retail locations in Pennsylvania, New Jersey, Maryland, New York, West Virginia, Virginia, and Delaware.

The problem was discovered by company personnel who learned of the incorrect labels being applied to the product and notified FSIS inspectors.

There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.