Tag Archives: National

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

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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

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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

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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

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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.

Pentagon Exhibit Showcases Wounded Warriors’ Therapeutic Art

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By Paige LaPlant

MSgt (Ret) Justin Jordan discusses the art process with U.S. Navy VADM Raquel Bono, Director, Defense Health Agency, at the opening of the Wounded Warrior Healing Arts Exhibit at the Pentagon in Arlington, Virginia, on April 12, 2017. (DoD photo by Roger L. Wollenberg)

WASHINGTON, April 12, 2017 — Healing arts therapy for wounded warriors can have a profound impact on those who have post-traumatic stress disorder and traumatic brain injury, and it also educates the medical community on treating such signatures of war, the director of the Defense Health Agency said today at the opening of the 2017 Wounded Warrior Healing Arts exhibit at the Pentagon.

Navy Vice Adm. (Dr.) Raquel C. Bono spoke at the kickoff of the Pentagon Patriotic Arts Program’s newest display, which will grace the walls of Apex 1 and 2 on the Pentagon’s second floor for a year.

The exhibit reflects the therapeutic artwork of service members who have suffered such maladies and found an outlet in many forms of art to help in managing their symptoms.

The military has used therapeutic arts programs since the inception of the National Intrepid Center of Excellence healing arts program in 2010 at Walter Reed National Medical Center in Bethesda, Maryland. It’s an expanding program across the nation’s military facilities, with numerous such programs in place or under way.

Signature Wounds

“One of lessons we took away from 15 years of war … is we realized there’s much more than fixing a person’s physical ability and injury,” Bono pointed out. And often, coping with such disorders with art therapy involves the community around the affected service member, she said. “l see it has a profound impact not only on your own healing, but to rest of community in terms of understanding and appreciation,” the admiral said.

Caring for a Network

“We learned we must be able to take care of the entire family and the entire network of our wounded warriors, and that was a real signature lesson we carried forward,” Bono noted.

But another piece of that equation, she said, is that military medicine learned to take care of spiritual, intellectual, mental, physical and religious domains that are important as wounded warriors transition from the military.

The DHA director told the numerous artists from the program who were in the audience that their ability to display their art in the halls of the Pentagon is an incredibly powerful way to express their messages that often cannot be put into words.

Likewise, she added, the artists’ sharing of their work with a broad audience will help others understand that complexities exist in everyone, and the complexities can exceed simple treatment and therapy.

“I want people to know who you are and what you’ve done,” Bono told the artists. “I thank you all for sharing, because I know this is a deeply personal part of who you are and what you’ve experienced.”

For more information, visit Healing Arts and the Military Health System and Pentagon Patriotic Art Program: Wounded Warrior Healing Arts Exhibit. View more photos from the opening event on Flickr and follow @WarriorCare on Twitter and Facebook for the latest in adaptive reconditioning events and updates.

By Terri Moon Cronk, DoD News, Defense Media Activity
Originally published on Defense.gov

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

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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

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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

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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

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.

Medtronic Announces Voluntary Worldwide Recall of its Stratamr Adjustable Valves and Shunts

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DUBLIN – Medtronic plc today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR™ adjustable valves and shunts. These products are manufactured and marketed by Medtronic’s Neurosurgery business, which is part of the Brain Therapies division of the company’s Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata™ II or Strata™ NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.Medtronic StrataMR adjustable valves and shunts are used in the management of hydrocephalus. They control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure. Medtronic is conducting this voluntary recall due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid.

Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting and lethargy.

  • If any of the affected products have been implanted in patients, physicians should refer to the StrataMR customer recall letter sent February 22, 2017 as well as the valve adjustment instructions in the instructions for use (IFU) for continued patient care.
  • Patients and their caregivers should monitor the patient’s condition and if they find they are experiencing any of the above-mentioned symptoms, they should consult the physician who implanted the StrataMR valve.

If left untreated, under-drainage can potentially lead to coma and death. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.

Medtronic initiated customer communication of the recall by letter and is requesting that customers cease use of all affected product that remains in inventory and return all unused units to Medtronic. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.

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, by regular mail, or by fax.

Precautionary Recall of a Limited Quantity of Organic Marketside Spring Mix Salad is Announced by Fresh Express

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Orlando, Fla. – Fresh Express is announcing a precautionary recall of a limited number of cases of Organic Marketside Spring Mix.

The item subject to the recall is 5 oz. Organic Marketside Spring Mix marketed in a clear container with production code G089B19 and best-if-used-by date of APR 14, 2017 located on the front label, and UPC code 6 8113132897 5 located on the bottom of the container. The recalled salads were distributed only to Walmart stores located in the Southeastern region of the United States.

The recall was necessitated when Fresh Express was notified that extraneous animal matter was allegedly found in a single container of the salad. Out of an abundance of caution, all salads manufactured in the same production run are being recalled.

No other Marketside salads are included in the recall. Fresh Express salads are not subject to a recall.

Walmart acted quickly to remove the product from store shelves.

Consumers who may have already purchased the recalled product should discard and not consume it. A full refund is available where purchased or by calling the Fresh Express Consumer Response Center toll-free at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern Time.

Upon receiving notification, both Walmart and Fresh Express food safety and rapid response teams, in close coordination with regulatory authorities, acted immediately to review all relevant records, launch an intensive investigation and initiate product removal and recall procedures.

Fresh Express takes matters of food safety very seriously and rigorously complies with all food safety regulations including the proscribed Good Agricultural Practices. In addition, a range of stringent controls are in place during growing and harvesting to mitigate against field material from entering the raw product system. In manufacturing, additional controls including thorough washing and filtration systems as well as visual inspections that are designed to eliminate unwanted debris.

Recalled Product Details

  • Organic Marketside Spring Mix – 5 oz. clear container
  • Production Code of G089B19 and best-if-used-by date of APR 14 2017, located on the top label
  • UPC Code of 6 8113132897 5 located on the bottom of the container next to the bar code

Recalled Product Distribution

Fresh Express Precautionary Recall, 5 oz. Organic Marketside Spring Mix
(No other Marketside Salads and No Fresh Express Salads are included in this recall)

Brand PRODUCT NAME SIZE UPC PRODUCTION CODE BEST IF USED BY DATE POSSIBLE DISTRIBUTION STATES
Marketside Organic Spring Mix 5 oz. 6 8113132897 5 G089B19 APR 14 2017 AL, FL, GA, LA, MS, NC, SC, VA,