Tag Archives: Food and Drug Administration

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.

David Trail Mix Sweet & Salty Voluntarily Recalled Due To Undeclared Dairy Allergen

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daves-1DAVID® Trail Mix Sweet & Salty flavor is being voluntarily recalled by ConAgra Foods of Omaha, Nebraska, due to the presence of an ingredient in the trail mix that contains milk protein, which is not declared on the packaging.

The finished product is made for ConAgra Foods by a third party supplier who is conducting a separate recall for similar, impacted products.

This food is a concern for people who are allergic to milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume the product. ConAgra Foods was made aware of this issue through a consumer contact. ConAgra Foods is aware of one consumer allergic reaction associated with consumption of this product.

ConAgra Foods is advising consumers who have purchased this item to discard it or return it to the store where originally purchased.

This recall includes the following DAVID Trail Mix Sweet & Salty products sold as part of multi variety packages that also contain DAVID Trail Mix Classic. DAVID Trail Mix Classic is not impacted by this recall.

The DAVID Trail Mix Sweet & Salty UPC is: 26200 23885, 5oz. bags/149g.

The product was shipped to retail food stores and distributors in the U.S. and Mexico. ConAgra Foods is working with retail customers and distributors to ensure the packages are removed from store shelves.

This recall is limited to DAVID Trail Mix Sweet & Salty flavor only and does not impact other flavors of DAVID Trail Mix or any DAVID Seeds products.

Consumers with questions should call our Consumer Affairs hotline at: (800) 881-3989, open 24 hours a day/7 days a week.

Safeway Recalls Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream

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safeway-select-ice-cream-18489PLEASANTON, Calif. — Safeway is voluntarily recalling Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream sold in all Safeway-owned stores from November 4, 2014 through December 5, 2014 due to the inclusion of an undeclared peanut allergen.

People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume this product. The recalled product is in a 1.5 quart package and displays the following UPC Code and Best Before Date.

Product Name UPC Code Best Before Date
Safeway Select French Salted Carmel (Fleur De Sel) Premium Ice Cream 21130 08970 Nov 03 2015

The UPC Code is located on the side panel. The Best Before Date is located on the bottom of the package.

No illnesses or injuries have been reported. The recipe’s caramel cups ingredient was replaced with peanut butter cups due to a supply error.

The recalled Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream was sold in all Safeway, Carrs, Genuardi’s, Pak ‘N Save, Pavilions, Randalls, Tom Thumb and Vons stores throughout the United States.

Customers are asked to discard the product or return it to their local store for a full refund. Customers who have questions about the recall can contact Safeway at 1-877-SAFEWAY.

Hawaii Firm Recalls Frozen Pork Products Due To Misbranding and Undeclared Allergen

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WASHINGTON – Kulana Foods Ltd., a Hilo, Hawaii establishment is recalling approximately 4,465 pounds of frozen, fully cooked pork products because of misbranding and an undeclared allergen. The products are formulated with a soy sauce that contains wheat, a known allergen, which is not declared on the label.

This is a Class II Recall which presents a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.

The products subject to recall include:

  • Various weight (approximately .75 – .90 lb.) packages of “MOUNTAIN APPLE BRAND Teri Smoked Pork” with identifying case codes: 03414, 07214, 12814, 16914, 21114, 28114, 03713, 05113, 06513, 23313, or 34513.
  • 5-pound packages of “MOUNTAIN APPLE BRAND Teri Smoked Pork” with identifying case code: 09214.

The products bear the establishment number “EST. 12445” inside the USDA mark of inspection on the label. The products were produced on various dates between Feb. 6, 2013 and Oct. 8, 2014 and shipped to retail locations and for foodservice use on the islands of Hawaii and Oahu.

The problem was discovered by FSIS personnel during a label review at the establishment. FSIS personnel are responsible for verifying that establishments are actively labeling the eight most common food allergens. Wheat was a sub-ingredient of soy sauce used in the product and was inadvertently left off the product label.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Marin Food Specialties, Inc. Initiates Voluntary Recall of Imported Organic Raw Almonds (Bitter Almonds)

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Due to Elevated Levels of Naturally Occurring Hydrogen Cyanide
raw-almonds
Marin Foods Specialties, Inc. of Byron, CA is voluntarily recalling Organic Raw Almonds (bitter almonds), due to them possibly containing elevated levels of naturally occurring hydrogen cyanide according to laboratory test results. To date, no human illnesses have been associated with these products and they have been pulled from sale.

Bitter almonds are the wild form of the edible “sweet almonds.” Bitter almonds contain a chemical called glycoside amygdalin, which becomes transformed into toxic prussic acid (hydrogen cyanide) after they are crushed or chewed. Eating foods that contain prussic acid may result in some or all of the following signs and clinical symptoms within minutes: dizziness, headache, nausea and vomiting, rapid breathing, rapid heart rate, restlessness, and weakness. Exposure to higher quantities of food containing prussic acid may cause other more serious health effects including convulsions, loss of consciousness, low blood pressure, lung injury, slow heart rate, and respiratory failure leading to death. Showing these signs and symptoms does not necessarily mean that a person has been exposed to cyanide. Treatment with supportive measures and available specific and efficacious antidotes frequently allows survival.

The products were labeled as “Whole Foods Market Organic Raw Almonds Imported from Italy” and “Whole Foods Market Organic Raw Almonds Imported from Spain,” and were packaged in 13.5 oz. plastic tubs. The recalled products have sell-by dates from 4/18/15 to 6/7/15 and a UPC code of UPC 9-99482-00071-7. The recalled product was distributed to Whole Foods Market stores only in Northern California, Oregon, Washington, Reno, Nevada and Boise, Idaho.

Whole Foods Market Melrose Recalls Vegan Gingersnap Cookies Due to Mislabeling and Undeclared Allergens

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ucm420686Cambridge, MA – Whole Foods Market is recalling “Vegan Gingersnap Cookies” produced and sold only in the Melrose, Massachusetts location due to a labeling error that resulted in undeclared tree nut, milk, soy and egg allergens. The product has a “Sell By” date of October 28, 2014.

The six-packs of cookies labeled as “Vegan Gingersnap Cookies” contained tree nuts (walnut and almond), milk, soy and egg, known allergens, which are not declared on the label. People who have an allergy or severe sensitivity to those ingredients run the risk of serious or life-threatening allergic reaction if they consume these products.

The cookies were sold in the store between October 23 and October 26, 2014.

Signage is posted to notify customers of this recall, and all affected product has been removed from shelves.

No allergic reactions or illnesses have been reported.

Consumers who have purchased this product from Whole Foods Market Melrose may bring their receipt to the store for a full refund. Consumers with questions should contact their local store or call 617-492-5500 between the hours of 9am and 5pm EST.

Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes

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300-Baby-Wipes1

FDA Photo. Sample Only. See Table.

MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred’s, Kidgets, Member’s Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam’s Club, Family Dollar, Fred’s, and Diapers.com.

After receiving a small number of complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of a bacteria, called Burkholderia cepacia (B. cepacia), in some of these products. Soon after, on October 3, 2014 the company initiated a voluntary withdrawal of lots that had tested positive for the bacteria, as well as other baby wipes in the surrounding time frame. After some additional lots were tested, as a precautionary measure, Nutek believed it was a prudent decision to withdraw all its baby wipe products.

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. If you believe you have a weakened immune system or chronic lung disease and you have used one of the affected wipe products, you should call your doctor promptly for medical advice.

As of October 3, 2014, the date of the original withdrawal, the company had received only one report of irritation. Numerous reports of complaints have since been received by the company that include rash, irritation, infections, fever, gastro-intestinal issues, and respiratory issues, though these reports have not been confirmed to be related to the use of these products.

The company has not identified the cause of the problem, but is continuing to investigate. In the interim, Nutek has stopped shipping baby wipes manufactured at the facility.

Nutek takes the safety of consumers and the quality of its products very seriously and is taking all appropriate steps to address the issue and ensure this does not happen again.

The company is working with the U.S. Food & Drug Administration and the affected retailers and distributors throughout this process to address the issue.
640-Baby-Wipes2

Brand Name Retailer Lot Numbers of Product Manufactured by Nutek
Cuties Internet and various retailers All Lots
Diapers.com Diapers.com All Lots
Femtex Family Dollar All Lots
Fred’s Fred’s All Lots
Kidgets Family Dollar All Lots
Member’s Mark Sam’s Club All Lots
Simply Right Sam’s Club All Lots
Sunny Smiles Walgreens All Lots
Tender Touch Various retailers All Lots
Well Beginnings* Walgreens Certain Lots±
*These lot numbers represent all lots manufactured by Nutek. There may be other lots that are made by manufacturers other than Nutek and that are not subject to this recall.

Lundberg Family Farms Recalls Sea Salt Rice Chips Due to Undeclared Allergen

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200pxfda-rice-chipsRICHVALE, Calif. — Lundberg Family Farms announced that it is voluntarily recalling from distribution in the United States and Canada, specific bags of Sea Salt Rice Chips due to possible presence of an undeclared dairy allergen. The issue was discovered through a consumer complaint.

The recall applies to only 6 ounce bags (170g) of Sea Salt Rice Chips packed on August 11th, 2014, bearing the code “140811” and a best before date of “2015 JUN 08” on the upper right-hand corner of the bag. The Sea Salt Rice Chips display the following UPC numbers 0-73416-03530-0 for U.S., or 0-73416-03540-9 for Canada.

Lundberg Family Farms has identified the problem and has taken immediate corrective action. Distributors and retailers have been notified and requested to discard the affected products in stock. The company notified the U.S. Food and Drug Administration, and is cooperating fully with the agency.

No serious injuries or illness have been reported from the consumption of the product. People who have a severe allergy to dairy run the risk of serious or life-threatening allergic reaction if they consume this product.

Customers who have bags of Sea Salt Rice Chips with the aforementioned labeling should discard them or return them unopened to the place of purchase for a refund. Customers can call our customer service representatives at 530-538-3555, which is staffed seven days a week, 8:30 a.m. to 5 p.m. Pacific Time, or leave a message at other times, with any questions or concerns about the product, or email recall@lundberg.com.

Maryland Firm Recalls Lamb Products Produced Without Import Inspection

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WASHINGTON – – E.&B.’s Natural Way, a Frederick, Md. establishment, is recalling approximately 27,948 pounds of raw lamb products because they were not presented at the border for USDA-FSIS Import Inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The lamb products were packaged on October 21, 2013, September 2, 20, 21 and 22, 2014. The following products are subject to recall:

  • Lamb Packs
  • Lamb Bone-In Legs
  • Lamb Boneless Legs
  • Lamb Saddles
  • Lamb Racks
  • Lamb Loins
  • Lamb Shoulders
  • Lamb Shanks
  • Lamb Trim
  • Lamb for Stew

The products subject to recall bear the establishment number “IS A022 EFTA” and include a label indicating “Product of Iceland.” These products were shipped to retail establishments in Washington and Oregon where the products would have been repackaged.

The problem was discovered during a routine review using the Automated Commercial Environment (ACE) database. ACE is a web-based portal for the collection and use of international trade data maintained by U.S. Customs and Border Protection. The failure-to-present was the result of the importing establishment not following appropriate procedures.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

FSIS issues a Public Health Alert for an imported product when the country of origin recalls the product. FSIS issues a recall for imported product when the product is not presented for inspection at the U.S. border.

A failure-to-present (FTP) occurs when importers fail to present a shipment to FSIS for import inspection prior to the product entering U.S. commerce. Failure-to-present will result in the recall of the product.

Consumers and media with questions about the recall can contact Blair Gordon, Owner, at (301) 471-5615.

AMS Health Sciences, LLC Issues Voluntary Recall of Saba Shark Cartilage Complex

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101031Oklahoma City, Oklahoma — AMS Health Sciences, LLC is notifying the public that it is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of Salmonella, an organism which can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. To date, no illness or complaints have been reported to AMS Health Sciences, LLC.

A single lot of Saba Shark Cartilage Complex is the subject of this public announcement and recall as a result of a sample from one bottle that tested positive for Salmonella. This product is packaged in black screw-top bottles with the brand name “saba” in red letters, the product name “shark cartilage complex” in white letters, and a net quantity statement of “500 mg 60 capsules” in small white letters. Product from the affected lot can be identified by the Lot Number 416349 and an expiration date of 08/16, both of which are printed in black letters inside a white rectangle that is adjacent to the products “Suggested Use” instructions.

Product from this lot was sold to consumers through the internet site www.sabaforlife.com during the period of February through August 2014. AMS is initiating this recall out of caution for consumer health, even though numerous samples from the same Lot No. have tested negative for Salmonella.

Any consumer who purchased product with the lot number and expiration date above should dispose of it immediately and may request a refund by calling (866) 758-7222, Monday through Friday, 9:00 am – 5:00 pm (Central). If you have consumed the product and are experiencing any unusual or severe symptoms such as those described above, go to an emergency room immediately or contact your physician for immediate advice.

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.