Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters

Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter.

This recall does not affect patients who have successfully undergone cardiac procedures using these devices. Abbott has already implemented corrective actions to ensure the products perform as intended.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications leading to death. The FDA has classified this as a Class I recall, where exposure to a device presents a reasonable likelihood of serious adverse health consequences or death. The cumulative frequency of reported events in difficulty of removing the sheath, and inflation and deflation of the balloon, is 0.12 percent worldwide.

Abbott began contacting customers in March who received coronary catheters from the affected lots, and is arranging the return and replacement of all remaining products. The total number of distributed units from identified lots potentially affected is 449,661. Global Health Authorities have been notified of the voluntary recall.

Specific lots of affected product were manufactured between January 1, 2015 to January 2, 2017, and were distributed between January 13, 2015 to March 14, 2017. For more information, please see Abbott’s field safety notice.

For Important Safety Information on NC Trek Catheters see PDF.

Valley Innovative Services Recalls Meat and Poultry Frozen Entrée Products Due to Possible Listeria Contamination

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WASHINGTON – Valley Innovative Services, a Pearl, Miss. establishment, is recalling approximately 130,071 pounds of meat and poultry frozen entrée products which included a non-meat ingredient (waffles) that was recalled due to Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The heat-treated, not fully cooked, not shelf stable chicken and waffle, turkey ham & waffle, and oatmeal with waffle and sausage patty frozen entrée items were produced and packaged from May 2016 through May 2017. The following products are subject to recall: [View Labels (PDF Only)]

  • 11.40-oz three compartment tray packages containing “Traditions Creamy Chicken Patty & Waffle with Four Seasons Vegetables and Cabbage” with the following production dates: 6/6/2016, 7/13/2016, 8/15/2016, 10/12/2016, 12/21/2016 and 4/11/2017; and the following sell-by dates: 6/6/2017, 7/13/2017, 8/15/2017, 10/12/2017, 12/21/2017 and 4/11/2018.
  • 11.35-oz three compartment tray packages containing “Traditions Creamy Chicken Patty & Waffle with Rib Meat with Cinnamon Flavored Sweet Potatoes and Seasoned Green Beans” with the following production dates: 10/12/2016, 11/18/2016, 12/21/2016, 1/26/2017, 1/30/2017 and 3/1/2017; and the following sell-by dates: 10/12/2017, 11/18/2017, 12/21/2017, 1/26/2018, 1/30/2018 and 3/1/2018.
  • 12-oz three compartment tray packages containing “Traditions Creamy Chicken Patty & Waffle with Cinnamon Flavored Sweet Potatoes and Four Seasons Vegetables” with the following production dates: 12/9/2016, 12/21/2016, 1/26/2017 and 1/30/2017; and the following sell-by dates: 12/9/2017, 12/21/2017, 1/26/2018 and 1/30/2018.
  • 9.20-oz three compartment tray packages containing “Traditions Turkey Ham & Waffle Cured Turkey Thigh meat Chunked and Formed with Fruit Cocktail and Hash Brown” with the following production dates: 12/12/2016, 1/21/2017, 1/30/2017, 3/16/2017, 3/21/2017, 4/3/2017, 4/5/2017, 4/18/2017, 4/26/2017; and the following sell-by dates: 12/12/2017, 1/21/2018, 1/30/2018, 3/16/2018, 3/21/2018, 4/3/2018, 4/5/2018, 4/18/2018, 4/26/2018.
  • 7.40-oz three compartment tray packages containing “Traditions Oatmeal with Waffle and Sausage Patty” with a production date of 10/14/2016 and a sell-by date of 10/14/2017.

The products subject to recall bear establishment number “EST. 18350” on the packaging label. These items were shipped to institutions nationwide.

The problem was discovered when Valley Innovative Services was notified by their waffle supplier that the waffle product used in the frozen entrée products was recalled due to potential Lm contamination. There have been no confirmed reports of adverse reactions due to consumption of these products.

Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

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. Consumers with questions regarding the recall can contact Jonathan Palmer, Customer Service Representative, at (601) 420-8847. Members of the media with questions regarding the recall can contact Brittany Mayer-Schuler, Vice President for Legal Affairs/General Counsel, at (866) 721-7859.

Green Chile Food Company Recalls Meat and Poultry Burrito Products Due to Possible Listeria Contamination

WASHINGTON – Green Chile Food Company, a Las Cruces, N.M. establishment, is recalling approximately 252,854 pounds of ready-to-eat (RTE) meat and poultry frozen burrito products because they may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.The ready-to-eat meat and poultry frozen burrito items were produced and packaged on various dates between March 8, 2017 and May 10, 2017. The following products are subject to recall:

  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, EGG & BACON BURRITO with Cheddar Cheese, Potato, Green Chile, Salsa & Jalapeños” with case code of 833425000900.
  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, POBLANO CHICKEN BURRITO with Monterrey Jack Cheese, Salsa, Rice, Onion, Green Chile and Green & Red Bell Peppers” with case code of 833425000931.
  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, BEEF & POTATO BURRITO with Cheddar Cheese, Green Chile & Salsa” with case code of 833425000887.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, Chipotle Chicken Burrito with Salsa & Monterey Jack” with case code of 833425001426.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, CARNITAS Burrito with Salsa, Monterey Jack & Cilantro Lime Rice” with case code of 833425001488.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, EGG & SAUSAGE Breakfast Burrito with HASHBROWNS, Salsa, & Cheddar” with case code of 833425000382.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, EGG & BACON Breakfast Burrito with HASHBROWNS, Salsa, Green Chile & Cheddar” with case code of 833425000368.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, BEEF Burrito with POTATO, GREEN CHILE, Salsa & Cheddar” with case code of 833425000320.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, CHICKEN FAJITA Burrito with Salsa & Cheddar” with case code of 833425000429.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, SHREDDED STEAK Burrito with Salsa, Monterey Jack, Green Chile, Onion, Rice & Jalapeño Peppers” with case code of 10833425008941.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, BEEF & BEAN Burrito with Green Chile, Salsa & Cheddar” with case code of 833425000344.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, FIESTA Breakfast Burrito with Beef, Egg, HASHBROWNS, GREEN CHILE, Cheddar & Sausage” with case code of 833425000405.

The products subject to recall bear establishment number “M-21740 or P-21740” inside the USDA mark of inspection. These items were shipped to institutions, retail stores and distribution centers in California, Illinois, Oregon, and South Dakota.

The problem was initially discovered by FSIS Inspection Program Personnel (IPP) during a routine Listeria monocytogenes product sample of beef and potato burrito. There have been no confirmed reports of illness due to consumption of these products.

Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.

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. Consumers with questions regarding the recall can contact Green Chile Concepts, Premiere Response Contact Center, at (800) 695-0843. Members of the media with questions regarding the recall can contact Greg Flack, CEO, at (952) 666-2995.

Lamb Weston Issues Allergy Alert on Undeclared Milk in Red Robin Burgers and Brews Crispy Onion Rings Sold in Grocery Stores

Lamb Weston is recalling 14 ounce packages of Red Robin Burgers and Brews Crispy Onion Rings manufactured by Fry Foods and sold in grocery stores, because the product may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

These products are NOT served in Red Robin restaurants. The Red Robin Burgers and Brews Crispy Onion Rings were distributed in the U.S. through retail grocery stores. No other products are impacted by this recall.

The product comes in a 14 ounce bag and is frozen. Details on the impacted packages are listed below. The Sell By Date and Package Code can be found on the back of the package. The HH:MM portion of the Package Code indicates the time product was made and will vary by package. Please refer to the images of the packaging included for additional information.

UPC Product Name Net Weight Sell By Dates Package Code
0 43301 61119 3 Red Robin Crispy Onion Rings 14 Oz Sell By OCT 28 2018
Sell By OCT 29 2018
6906711841 HH:MM
6906711941 HH:MM

No illnesses have been reported to date in connection with this product.

The recall was initiated after it was discovered that contract manufacturer Fry Foods mistakenly packed product containing milk in packaging that did not reveal the presence of milk. Subsequent investigation indicates the product did not meet Lamb Weston specifications.

Consumers who have purchased Red Robin Burgers and Brews Crispy Onion Rings from a grocery retailer are urged to return the product to the place of purchase for a full refund.

Fry Foods and Lamb Weston are cooperating with the FDA on this recall and working with customers to ensure packages are removed from store shelves and are no longer distributed.

Consumers with questions about this recall may contact 1-866-518-0137, Monday-Friday, from 9 a.m. – 6p.m. EDT.

Trident Seafoods Corporation Recalls Frozen Multi-Grain Alaskan Cod

Trident Seafoods Corporation is issuing a voluntary recall of select lots of frozen Multi-Grain Alaskan Cod, Net Wt. 12, oz., because they may contain small pieces of plastic. Consumption of these products may pose a choking hazard or other physical injury to the mouth.

The following retail product is subject to the voluntary recall:

Trident Seafoods Multi-Grain Alaskan Cod (Frozen), Net Wt. 12oz., UPC 0 28029 21048 4

Recalled Lot Numbers with associated Best By dates are printed on one end of the individual retail cartons and on the case label.

• Lot Number A633511, Best By: 11/30/2018
• Lot Number A636225, Best By: 12/27/2018

Lot Number A633511 – Distributed between 12/1/2016 and 2/9/2017 to Arizona, California, Colorado, Illinois, Kansas, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington, and Wisconsin

Lot Number A636225 – Distributed between 1/23/2017 and 2/17/2017 to Arizona, California, Colorado, Illinois, Kansas, Massachusetts, Texas, Washington, and Wisconsin

These products are sold at Albertsons, Amazon, Cub Foods, Jewel, Morey’s, Plaza Extra, Shaw’s, Shoprite, Sprouts, SUPERVALU, and Woodman’s retailers.

This issue was discovered through consumer feedback. The source of the white plastic has been identified as inspection tags used by an ingredient supplier. Trident Seafoods takes food safety very seriously and is investigating this situation thoroughly.

There have been no reports of injury or illness related to the recalled products to date, however 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. For additional information consumers can call Ms. Trev Foley, Consumer Affairs Manager, at 206-297-5825, Monday – Friday, 8 a.m. – 5 p.m. PST, or send email to trevf@tridentseafoods.com .

U.S. Deer Antler EX. & IM., INC. Announces The Recall Of Herbal Tea Varieties In Pouches

U.S. Deer Antler Ex. & Imp., of Los Angeles, CA is recalling a variety of Herbal Teas prepared on premises between 4/1/17 and 4/30/17 in cooperation with an inspection made by the California Department of Public Health. The aforementioned Herbal Teas, especially those with low-acidity held at room temperature, were not produced according to approved guideline, making them susceptible to contamination by Clostridium botulinum.

Below are the product descriptions and photographs:

Products Packaging Cases
Herbal Tea Variety Batches prepared on premise between 4/1/17 – 4/30/17 120 ml/ Pouch 40 Pouches / Case

The Herbal Teas were distributed to individual customers and acupuncturists in California, Florida, Illinois, Maryland, North Carolina, Texas, and Virginia.

Symptoms of Clostridium botulinum typically begin with blurred or double vision followed by trouble speaking, swallowing; and progression to muscle weakness starting in the upper body, moving downward.  Botulism can lead to life-threatening paralysis of breathing muscles requiring support with a breathing machine (ventilator) and intensive care. http://www.cdph.ca.gov/HealthInfo/discond/Pages/Botulism.aspx

People experiencing these symptoms who have recently consumed these Herbal Teas should seek immediate medical attention.

In its ongoing cooperation with the California Department of Public Health, U.S. Deer Antler Ex. & Imp., Inc. has immediately segregated its entire inventory of Herbal Tea varieties, and is notifying consumers and customers not to consume potentially-contaminated product. Furthermore, U.S. Deer Antler Ex. & Imp. Inc. is voluntarily recalling all varieties of general Herbal Teas prepared on-site in the period of 4/1/17 to 4/30/17 to ensure consumer safety.

Consumers in possession of these products are to stop consumption and return unconsumed product to their original place of purchase.

U.S. Deer Antler Ex. & Imp., Inc. will be sending recall notices to all of its direct customers.  Please contact Joong W. Park (323) 735-9665 for further information.

ReFlow Medical Issues Recall of Specific Lots of Wingman35 Crossing Catheters

WASHINGTON, D.C. – On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.

The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury. The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. ReFlow has received 2 complaints of catheter-tip splitting and/or separation. A total of 2327 Wingman catheters are in distribution.

Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

The Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.

ReFlow Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.

FDA and other regulatory agencies around the world have been notified of this action.

Consumers with questions may contact ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Pacific time or by email at info@reflowmedical.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 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, and then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD(TM) System Controllers and DC Adapters as Class I Recall

Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company’s recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.

Medtronic began notifying clinicians outside of the United States in March 2017 about updated HVAD System Controllers and DC Adapters that were developed following two previously communicated Field Safety Notices that occurred in April 2015 and April 2016. The FDA approved the updated controller on April 7, 2017, and Medtronic began notifying U.S. clinicians about the updated HVAD Controllers and DC Adapters on April 14, 2017.

The updated controller includes enhancements designed to address the potential safety issues identified in the previously communicated notices, including:

  • strengthened power and serial port alignment guides intended to reduce the incidence of wear that could lead to damaged connector pins;
  • functionality designed to monitor internal battery performance and sound an alert when the internal battery is nearing depletion; and
  • redesigned connectors and housing intended to prevent the risk of connectors loosening or becoming more vulnerable to damage from exposure to water and other fluids.

In addition, the updated controller introduces upgraded internal circuitry designed to improve overall device reliability.

In April 2015 and April 2016, Medtronic notified clinicians about potential safety issues with the current HVAD System Controller that could lead to possible injury and death due to worn alignment guides, internal “double disconnect (no power) alarm” battery failure, and loose power and data connectors.

With the introduction of the updated controller, Medtronic has begun to remove current HVAD Controllers (product codes 1400,1401US and 1407US) in select geographies, including the U.S. Medtronic also has begun to remove the related adapters (product code 1435), Instructions for Use, Patient Manuals and Emergency Responder Guides.

As part of these activities, Medtronic has provided the following recommendations to physicians:

  • Before the updated controller will be distributed to hospitals, clinicians must complete required training on the updated controller and updated product labeling, including the Instructions for Use and Patient Manual.
  • Following training and the receipt of the updated controllers in hospital inventory, clinicians are requested to quarantine and replace patients’ primary and backup HVAD Controllers and DC adapters under clinical supervision and at a hospital where patient support equipment is available.
  • While Medtronic recommends that HVAD Controllers be exchanged, clinicians should weigh the benefits of the updated controller against the risks of a controller exchange procedure.
  • When clinicians determine a controller exchange is appropriate, they will notify patients who should promptly schedule a controller exchange as soon as the updated controllers are available.
  • Trained hospital staff must educate patients on using the updated controller.

Patients with questions about this announcement should contact their physicians or ventricular assist device (VAD) coordinator at their hospital center.

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

For information or to report a problem, please contact the 24-hour Clinical Support line at +1-888-494-6365 or email FSCA@medtronic.com.

Frito-Lay Recalls Jalapeño Flavored Lay’s Kettle Cooked Potato Chips and Jalapeño Flavored Miss Vickie’s Kettle Cooked Potato Chips

Frito-Lay announced it is voluntarily recalling select Jalapeño Flavored Lay’s Kettle Cooked potato chips and Jalapeño Flavored Miss Vickie’s Kettle Cooked potato chips due to the potential presence of Salmonella in the seasoning. Salmonella is 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.

This action is the direct result of a supplier’s recent recall of a seasoning blend which includes jalapeño powder that could contain Salmonella. Although no Salmonella was found in the seasoning supplied to Frito-Lay, the company has decided to recall these products out of an abundance of caution.

No illness related to this matter has been confirmed to date.

The products covered by this recall were distributed in retail stores and via foodservice, vending and other channels throughout the U.S.

The specific recalled product information is listed below:

  • All sizes of the following two products that have a “guaranteed fresh” date of JUL 4 or prior printed on the front upper panel of the package:
    • Jalapeño Flavored Lay’s Kettle Cooked potato chips
    • Jalapeño Flavored Miss Vickie’s Kettle Cooked potato chips
  • All of the following multipack offerings that have a “use by” date of JUN 20 or prior printed on the multipack package. In addition, a “guaranteed fresh” date of JUL 4 or prior is printed on the front upper panel of the individual recalled product packages inside each multipack offering. Any other products or flavors contained in these multipacks are not being recalled.
    • 12 count Lay’s Kettle Cooked Multipack Sack
    • 20 count Frito-Lay Bold Mix Sack
    • 30 count Miss Vickie’s Multipack Tray
    • 30 count Lay’s Kettle Cooked Multipack Tray
    • 32 count Miss Vickie’s Multipack Box

No other flavors of Lay’s Kettle Cooked potato chips or Miss Vickie’s potato chips are impacted or being recalled. Jalapeño Cheddar Flavored Lay’s Kettle Cooked 40% Less Fat potato chips are not impacted or being recalled.

Consumers who have purchased these recalled products are advised not to consume them. Frito-Lay is working with the FDA on this recall to ensure the recalled products are removed from store shelves and are no longer distributed.

Consumers can contact Frito-Lay Consumer Relations at 866-272-9393 for additional information from 9 a.m. to 6 p.m. EST. Representative product images can be found at fritolay.com. For product reimbursement, consumers can visit www.jalapenochiprecall.com.

Campbell Soup Company Recalls Chicken Soup Products Due to Misbranding and Undeclared Allergens

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


Campbell Soup Company, a Maxton, N.C. establishment, is recalling approximately 4,185 pounds of chicken soup products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain milk, a known allergen, which is not declared on the product label. The chicken with whole grain pasta soup items were produced on Feb. 13, 2017.

18.6-oz. cans of “Campbell’s Homestyle Healthy Request Chicken with Whole Grain Pasta” with Best By date of Feb. 13, 2019 located on the bottom of the cans.

The products subject to recall bear establishment number “EST. 4R” on the bottom of the cans. These items were shipped to retail locations in Florida.

The problem was discovered on April 20, 2017 when the firm received notification from their corporate office of multiple consumer complaints of the wrong product noticed inside the cans. The products were labeled as “Campbell’s Homestyle Healthy Request Chicken with Whole Grain Pasta” but actually contain “Campbell’s Homestyle Healthy Request Italian-Style Wedding Spinach & Meatballs in Chicken Broth” soup.

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.