Category Archives: Recall

Mars Petcare US Announces Voluntary Recall of Limited Number of CESAR® Classics Filet Mignon Flavor Wet Dog Food

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caeser524703Franklin, Tennessee — Today, Mars Petcare US announced a voluntary recall of a limited number of CESAR® Classics Filet Mignon Flavor product due to a potential choking risk from hard white pieces of plastic which entered the food during the production process. CESAR® Classics Filet Mignon can be purchased individually, as well as, in flavor variety multipacks. The Lot Codes listed below are the only affected products. All other CESAR® products can be safely consumed.

We encourage consumers who have purchased affected product to discard the food or return it to the retailer for a full refund or exchange. While a small number of consumers have reported finding the plastic pieces, to date, we have not received any reports of injury or illness associated with the affected product. The lot codes indicated below should not be sold or consumed.

Affected product was distributed to retail customers throughout the United States. Mars Petcare US is working with all of our distributors and retailers to ensure that the recalled products are no longer sold and are removed from inventory.

Recalled Pet Food

Two lot codes of CESAR® Classics Filet Mignon Flavor wet dog food with the production codes shown below are included in this voluntary recall. Each product will have a lot code printed on side of the tray that begins with 631FKKC, 631GKKC. A Best Before date 080418 (August 4, 2018) and 080518 (August 5, 2018).

The CESAR® Classics Filet Mignon Flavor can be found in variety packs with the following lot codes:

632D14JC, 633B24JC, 634A14JC, 634A24JC, 634B14JC, 634B24JC, 634E14JC, 635A24JC, 635B14JC, 636D24JC, 636E14JC

At Mars Petcare US, we take our responsibility to pets and their owners seriously. Pet owners who have questions about the recall should call 800-421-6456 between the hours of Saturday, October 8, 8:00 am to 12:00 pm CST and Monday through Friday 8:00 am to 4:30 pm CST or visit https://www.cesar.com/notice.

Vascular Solutions, Inc. Issues Recall of Twin-Pass® Dual Access Catheters

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On September 16, 2016, Vascular Solutions, Inc., initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date.

Healthcare facilities that have the affected Twin-Pass dual access catheters should remove the products from their inventory and return them to Vascular Solutions.

The recalled products were manufactured from October 2014 to August 2016 and distributed from October 2014 to September 2016.

The recalled products are all unexpired lots of Model Numbers 5200, 5210, and 5230. 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 15,896 devices have been manufactured, with 5,784 distributed in the United States and currently unexpired. The condition that led to the recall may affect approximately 9.2% of recalled devices.

Vascular Solutions, Inc. voluntarily initiated the recall on September 16, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific unexpired 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 Online at http://www.fda.gov/medwatch/report.htm (form available to fax (1-800-FDA-0178) or mail), or you may call the FDA at 1-800-FDA-1088 to request a reporting form.

Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers

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lunch-1WASHINGTON D.C. — Kraft Heinz Company, a Fullerton, Calif. establishment, is recalling approximately 959 pounds of ready-to-eat “Lunchables Ham and American Cracker Stackers” packaged lunch products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat and soy, known allergens, which are not declared on the product label.

The ready-to-eat meat and cheese packaged lunch items were produced on September 21, 2016. The following products are subject to recall:

3.4-oz. boxes containing four-compartment plastic trays of “Lunchables Ham and American Cracker Stackers,” with a “USE BY” date of 25 DEC 2016 and production times ranging from 9:13 to 10:00 stamped on the side of the plastic container.

The products subject to recall bear establishment number “EST. 537K” inside the USDA mark of inspection. These items were shipped to retail locations in Utah and California.
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lunch-3
The problem was discovered on October 6, 2016, when the firm received a consumer complaint. There were no illnesses associated with the complaint.

The establishment determined that the “Lunchables Ham and American Cracker Stackers” products were incorrectly labeled with the back label for a “Nacho Lunchable” product. The back label contains the product ingredient statements and as such, the “Lunchables Ham and American Cracker Stackers” products that were mislabeled do not declare wheat and soy on the label.

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

Consumers who have purchased this product are urged not to consume it. This product 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. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact the Kraft Heinz Consumer Relations Center, at 1-800-573-3877. Members of the media with questions about the recall can contact Lynne Gaila, Corporate Affairs Director, Kraft Heinz Company, at (847) 646-4396 or lynne.galia@kraftheinzcompany.com.

Tyson Foods Inc. Recalls Chicken Nugget Products

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WASHINGTON — Tyson Foods Inc., a Sedalia, Mo. establishment, is recalling approximately 132,520 pounds of fully cooked chicken nugget products that may be contaminated with hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

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

The fully cooked Panko Chicken Nuggets items were produced on July 18, 2016. The following products are subject to recall:
tyson-1

  • 5-lb. bag containing “Tyson FULLY COOKED PANKO CHICKEN NUGGETS” with a “Best If Used By” date of July 18, 2017 and case code 2006SDL03 and 2006SDL33.
  • 20-lb. bulk packages containing “SPARE TIME Fully Cooked, Panko Chicken Nuggets, Nugget Shaped Chicken Breast Pattie Fritters With Rib Meat” with a production date of July 18, 2016 and case code 2006SDL03.

tyson-2
The products subject to recall bear establishment number “EST. 13556” printed adjacent to the “Best If Used By” date on the back of the package. The 20-pound cases were shipped for institutional use in Pennsylvania and the five-pound bags were shipped to retail locations nationally.

The problem was discovered after the firm received consumer complaints regarding foreign material contamination of chicken nugget products. According to Tyson Foods, the plastic material ranged in size from 21mm in length and 6.5mm in diameter and may have come from a round, hard plastic rod used to connect a plastic transfer belt. The firm said the products pass through a metal detector, but the plastic is not detectable to this technology.

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.

Honeywell recalls one lot of Eyesaline Eyewash Solution

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In cooperation with the U.S. Food and Drug Administration (FDA), Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury.

Although no injuries have been reported and we have not found any contamination in our batch testing, the voluntary recall is a precautionary measure due to a low risk of product contamination with Klebsiella pneumoniae. Although found in the normal flora of the mouth and skin, if the contaminant were present in a bottle, there is a potential for it to result in infections that may be sight-threatening.

Eyesaline Eyewash is sold through industrial sales distributors. Approximately 9,700 32-ounce bottles with lot number F16091-61 are subject to recall. No other lot number of the product is subject to this recall.

All of Honeywell’s distributors who received this lot have been notified by phone, e-mail and certified mail, and have been instructed to notify their customers. See instructions below on how to find the lot number to determine if your supply is covered by this voluntary recall.

Distributors must stop distribution of the affected product and return it to Honeywell for credit or replacement.  Commercial-industrial users of the product should also check whether their Eyesaline Eyewash is subject to recall. If it is, customers should stop using the solution and contact their distributor for replacement or credit.
ucm517444ucm517445
The affected product and lot number can be identified as follows:

  • Product: 32 ounce Eyesaline Eyewash
  • Lot number:  F16091-61 (no other lot number is subject to recall)
  • The lot number can be found on the outside of the product case, shown at left, and on individual bottles, as shown on the right below.

Customers with questions regarding this recall can contact their distributor or Honeywell Customer Care at 1-800-430-5490, Monday – Friday, and 8:00 am – 6:30 pm EST.  Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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).