Category Archives: Recall

Russell Stover Chocolates Issues Allergy Alert on Undeclared Pecan in Sugar Free Peanut Butter Cups

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Russell Stover Chocolates of Kansas City, Missouri, is voluntarily recalling two (2) Best Before Dates of its Sugar Free Peanut Butter Cups in 2.4 oz packaging due to the potential for undeclared pecans. The recalled Sugar Free Peanut Butter Cups may contain Sugar Free Pecan Delights. Pecans are not declared on the label. People who have an allergy or severe sensitivity to pecans run the risk a serious or life-threatening allergic reaction if they consume these products.

The recalled Sugar Free Peanut Butter Cups were distributed nationwide to wholesale and retail stores.

The recalled Sugar Free Peanut Butter Cups are packaged in a 2.4 oz plastic bag, and they are labeled with Best Before dates of 01MAY23 and 01JUN23 and UPC of 077260096937 with Lot code(s): K0521, K0321, K0421, L2122, L2221, L2321. The lot code and best before date can be found on the back of the product packaging, below the UPC.

The recall was initiated following consumer contacts regarding the wrong product inside the outer packaging for Sugar Free Peanut Butter Cups product. Russell Stover has received no reports of any illness or allergic reactions related to this issue to date.

Medex Cardio-Pulmonary Recalls Sterile Saline and Sterile Water

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death

Recalled Product(s):

  • Select serial and lot numbers of Smiths Medical Sterile Saline and Water (listed below)
  • Manufacturing Dates: August 30, 2013, to February 10, 2017
  • Distribution Dates: August 30, 2013, to February 10, 2017
  • Full list of affected devices
  • Devices Recalled in the U.S.: 939,364

Device Use

The sterile saline and water are respiratory humidification products used in patients undergoing respiratory therapy, tracheal wash, or wound cleaning.

Reason for Recall

Smiths Medical is recalling the sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents (bacillus infantis and staphylococcus epidermidis) because of damage to the containers used to package the finished products. Use of these products in patients could result in infection and may require treatment with antibiotics. Serious or untreated infections could result in patient death.

The company initiated a voluntary recall on September 5, 2017. That recall covered several products, including some that are outside the scope of this notice. The FDA is auditing the recall to ensure the company has notified all affected customers and that affected product has been returned. Based on the available information, the FDA is now classifying the action regarding the affected products (listed below) as a Class I recall.

Who May be Affected

  • Hospitals and health care professionals using Smiths Medical Sterile Saline or Water distributed from August 30, 2013, to February 10, 2017.
  • Patients receiving respiratory therapy or tracheal lavage with Smiths Medical Sterile Saline or Water distributed from August 30, 2013, to February 10, 2017.

What to Do

On September 5, 2017, Smiths Medical sent affected customers an “Urgent Medical Device Recall Notice” informing them of affected sterile water and saline product models and directing them to locate, determine the affected sterile saline or water products in their possession, and to complete the “Urgent Medical Device Recall Response Form” attached to the recall notice. Customers were also instructed to return all affected product to Stericycle for processing.

On January 7, 2019, distributer Medline Industries Inc. initiated a sub-recall for privately labeled product models and lots, affected by the September 5, 2017, Smiths Medical recall notice, that were not expired and which may be potentially contaminated with the infectious agents.

The notice asked customers to:

  1. Locate the affected Sterile Water, Saline and Eye Wash in their possession by referring to the specific model and lot numbers listed in the Urgent Medical Device Field Recall Response Form.
  2. Determine the number of affected devices in their possession and complete the Urgent Medical Device Field Recall Response Form attached to this letter within 10 days of receipt and send it to smithsmedicalste00100@stericycle.com. The form must be returned even if customers do not have any of the affected Sterile Water, Saline and Eye Wash in their possession. Product credit will be processed once the Urgent Medical Device Field Recall Response Form and affected product is received. All affected devices must be returned to Stericycle for processing. Pre‐paid shipping labels were included with the Urgent Medical Device Recall Notice.
  3. Package the affected devices and include a copy of the completed Urgent Medical Device Field Recall Response Form inside EACH BOX of the returned devices to obtain credit for the returned devices. Make sure boxes are sealed and labeled with the facility name prior to shipping devices to Stericycle.

Distributors are asked to immediately notify customers who received the affected product of this Recall.

Contact Information

Customers with questions regarding this notification may contact Stericycle via email at smithsmedicalste00100@stericycle.com.

Date Recall Initiated

September 5, 2017

Full List of Affected Devices

  • Portex 350 ml Sterile Water Humidifier w/5psi Adapt (Model # 352 Lot Numbers: A214, A215, Z263, Z532, and Z555)
  • Portex 550 ml Sterile Water Humidifier w/5psi Adapt (Model # 552 Lot Numbers: A054, A089, A090, and Z262)
  • Portex 1000 ml Sterile Water USP Pour Bottle (Model # 1065 Lot Numbers: B209 and Z225)
  • Portex 500 ml Sterile Water USP Pour Bottle (Model # 1565 Lot Number: Y371)
  • Intermed 350 ml Sterile Water Humidifier w/5psi Adapt. (Model # 0352IMJ Lot Numbers: A457, A597, B157, B236, Z589, Z655, Z656, and Z661)
  • Portex 550 ml Sterile Water Humidifier w/5psi Adapt. (Model # 0552C Lot Number: Z370)
  • Intermed 550 ml Sterile Water Humidifier w/5psi Adapt. (Model # 0552IMJ Lot Numbers: Z588 and Z597)
  • Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt. (Model # HCS00300 Lot Number: Y576)
  • Medline Prefilled 350 ml Sterile Water (Model # HCS00350 Lot Numbers: A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554)
  • Portex Unit Dose 5 ml Normal Saline (0.9%) (Model # R0059 Lot Number: B360), K820227
  • Portex Unit Dose 15 ml Normal Saline (Model # R0159 Lot Numbers: A661, B067, A526, A536, A569, and B201)
  • Portex 5ml Normal Saline (0.9%) Unit Dose (Model # UD9005 Lot Number: B515), K820227
  • Medline Prefilled 550 ml Sterile Water (Model # HCS00550 Lot Numbers: A092, B205, B534, and Z205)

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops

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Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1 To date, no serious adverse events have been reported related to this recall.

The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles. This voluntarily recall includes the six (6) lots listed below:

Lot No. NDC EXPIRATION DESCRIPTION COMPANY
4718 59779-925-23 12/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle CVS Pharmacy
00717005A 49035-125-24 02/19 Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle Wal-Mart Stores Inc.
00717006A 59779-925-24 

(Labeled as: 50428-1252-4)

 02/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle CVS Pharmacy
00717009A
(Previously announced) 		49035-125-23 02/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
00717015A
(Previously announced) 		49035-125-23 04/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
00717024A
(Previously announced) 		49035-125-23 08/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
59779-925-23 CVS Health: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle		 CVS Pharmacy
55319-250-23 Family Wellness: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle		 Family Dollar Services Inc.

Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. The retailers should stop further distribution of the affected lots, which are being recalled. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors.

Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com. Consumers, who may be concerned, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). The FDA has approved a class II retail level recall for this recall,

Tyson Foods, Inc. Recalls Chicken Nugget Products due to Possible Foreign Matter Contamination

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WASHINGTON DC – Tyson Foods, Inc., a Sedalia, Mo. establishment, is recalling approximately 36,420 pounds of chicken nugget products that may be contaminated with extraneous materials, specifically rubber, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The panko chicken nugget items were produced on Nov. 26, 2018. The following products are subject to recall:

5-lb. plastic packages of “Tyson WHITE MEAT PANKO CHICKEN NUGGETS” with a “BEST IF USED BY” date of “NOV 26 2019,” case code “3308SDL03” and time stamps 23:00 through 01:59 (inclusive).

The products subject to recall bear establishment number “P-13556” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

The problem was discovered when the establishment received consumer complaints of extraneous material in purchased Panko Chicken Nugget products. FSIS was notified on Jan. 29, 2019.

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.

FSIS is concerned that some product may be frozen and in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. 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 Tyson Consumer Relations at 1-888-747-7611. Members of the Media with questions about the recall can contact Worth Sparkman, Senior Communications Manager with Tyson Foods, Inc., at (479) 290-6358.

Hill’s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D

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Hill’s Pet Nutrition is voluntarily recalling select canned dog food products due to potentially elevated levels of vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of exposure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction. Pet parents with dogs who have consumed any of the products listed and are exhibiting any of these signs should contact their veterinarian. In most cases, complete recovery is expected after discontinuation of feeding.

In the United States, the affected canned dog foods were distributed through retail pet stores and veterinary clinics nationwide. No dry foods, cat foods, or treats are affected.

Pet parents who purchased the product with the specific lot/date codes listed should discontinue feeding and dispose of those products immediately or return unopened product to your retailer for a refund. For more information, please contact Hill’s via our website or at 1-800-445-5777.

Hill’s Pet Nutrition learned of the potential for elevated vitamin D levels in some of our canned dog foods after receiving a complaint in the United States about a dog exhibiting signs of elevated vitamin D levels. Our investigation confirmed elevated levels of vitamin D due to a supplier error.

We care deeply about all pets and are committed to providing pet parents with safe and high quality products. Hill’s has identified and isolated the error and, to prevent this from happening again, we have required our supplier to implement additional quality testing prior to their release of ingredients. In addition to our existing safety processes, we are adding our own further testing of incoming ingredients.

For further information, please contact Hill’s Pet Nutrition, Inc. at 1-800-445-5777 Monday-Friday during the hours of 9am-5pm (CST) or at contactus@hillspet.com. Information can also be found at www.hillspet.com/productlist

This voluntary recall only impacts canned dog food and primarily in the United States. It is being conducted in cooperation with the U.S. Food and Drug Administration. Impacted products outside of the United States will be subject to separate notices on the country-specific website. If you are outside of the United States, please check your own country’s Hill’s website for more information.

Product Name SKU Number Lot Code/Date Code
Hill’s® Prescription Diet® c/d® Multicare Canine Chicken & Vegetable Stew 12.5oz 3384 102020T10
102020T25
Hill’s® Prescription Diet® i/d® Canine Chicken & Vegetable Stew 12.5oz 3389 102020T04
102020T10
102020T19
102020T20
Hill’s® Prescription Diet® i/d® Canine Chicken & Vegetable Stew 5.5oz 3390 102020T11
112020T23
122020T07
Hill’s® Prescription Diet® z/d® Canine 5.5oz 5403 102020T17
112020T22
Hill’s® Prescription Diet® g/d® Canine 13oz 7006 112020T19
112020T20
Hill’s® Prescription Diet® i/d® Canine 13oz 7008 092020T30
102020T07
102020T11
112020T22
112020T23
Hill’s® Prescription Diet® j/d® Canine 13oz 7009 112020T20
Hill’s® Prescription Diet® k/d® Canine 13oz 7010 102020T10
102020T11
Hill’s® Prescription Diet® w/d® Canine 13oz 7017 092020T30
102020T11
102020T12
Hill’s® Prescription Diet® z/d® Canine 13oz 7018 102020T04
112020T22
Hill’s® Prescription Diet® Metabolic + Mobility Canine Vegetable & Tuna Stew 12.5oz 10086 102020T05
102020T26
Hill’s® Prescription Diet® w/d® Canine Vegetable & Chicken Stew 12.5oz 10129 102020T04
102020T21
Hill’s® Prescription Diet® i/d® Low Fat Canine Rice, Vegetable & Chicken Stew 12.5oz 10423 102020T17
102020T19
112020T04
Hill’s® Prescription Diet® Derm Defense® Canine Chicken & Vegetable Stew 12.5oz 10509 102020T05
Hill’s® Science Diet® Adult 7+ Small & Toy Breed Chicken & Barley Entrée Dog Food 5.8oz 4969 102020T18
Hill’s® Science Diet® Puppy Chicken & Barley Entrée 13oz 7036 102020T12
Hill’s® Science Diet® Adult Chicken & Barley Entrée Dog Food 13oz 7037 102020T13
102020T14
112020T23
112020T24
Hill’s® Science Diet® Adult Turkey & Barley Dog Food 13oz 7038 102020T06
Hill’s® Science Diet® Adult Chicken & Beef Entrée Dog Food 13oz 7040 102020T13
Hill’s® Science Diet® Adult Light with Liver Dog Food 13oz 7048 112020T19
Hill’s® Science Diet® Adult 7+ Chicken & Barley Entrée Dog Food 13oz 7055 092020T31
102020T13
Hill’s® Science Diet® Adult 7+ Beef & Barley Entrée Dog Food 13oz 7056 092020T31
112020T20
112020T24
Hill’s® Science Diet® Adult 7+ Turkey & Barley Entrée 13oz 7057 112020T19
Hill’s® Science Diet® Adult 7+ Healthy Cuisine Braised Beef, Carrots & Peas Stew dog food 12.5oz 10452 102020T14
102020T21
Hill’s® Science Diet® Adult 7+ Youthful Vitality Chicken & Vegetable Stew dog food 12.5oz 10763 102020T04
102020T05
112020T11

Jennie-O Turkey Store Sales, LLC Recalls Raw Ground Turkey Products

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WASHINGTON D.C. — Jennie-O Turkey Store Sales, LLC, a Barron, Wis. establishment, is recalling approximately 91,388 pounds of raw ground turkey products that may be associated with an illness outbreak of Salmonella Reading, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The raw ground turkey products items were produced on September 11, 2018. The following products are subject to recall:

  • 1-lb. packages of “Jennie-O GROUND TURKEY 93% LEAN | 7% FAT” with “Use by” dates of 10/01/2018 and 10/02/2018.
  • 1-lb. packages of “Jennie-O TACO SEASONED GROUND TURKEY” with a “Use by” date of 10/02/2018.
  • 1-lb. packages of “Jennie-O GROUND TURKEY 85% LEAN | 15% FAT” with a “Use by” date of 10/02/2018.
  • 1-lb. packages of “Jennie-O ITALIAN SEASONED GROUND TURKEY” with a “Use by” date of 10/02/2018.

The products subject to recall bear establishment number “P-190” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

FSIS, and its public health partners, including the Centers for Disease Control and Prevention (CDC) and the Arizona Department of Health Services, have been conducting traceback activities for a sample of Jennie-O brand ground turkey in an intact, unopened package from a case-patient’s home. The patient tested positive for Salmonella Reading and the sample from the ground turkey matches the outbreak strain.

FSIS, the CDC, and state public health and agriculture partners, have been working together on an illness cluster involving 164 case-patients in 35 states. Patients have reported eating different types and brands of turkey products purchased from many different stores, handling raw turkey pet food and/or raw turkey, or working with live turkeys or living with someone who handled live turkeys. FSIS continues to work with the CDC and state health departments on this investigation and will provide updated information as it becomes available. Based on the continuing investigation, additional product from other companies may also be recalled.

Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating the contaminated product. The illness usually lasts 4 to 7 days. Most people recover without treatment. In some persons, however, the diarrhea may be so severe that the patient needs to be hospitalized. Older adults, infants, and persons with weakened immune systems are more likely to develop a severe illness. Individuals concerned about an illness should contact their health care provider.

FSIS is concerned that some product may be frozen and in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution lists will be posted on the FSIS website at www.fsis.usda.gov/recalls.

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume raw poultry product that has been cooked to a temperature of 165°F. Safe steps in food handling, cooking, and storage are essential in preventing foodborne illness. You can’t see, smell, or taste harmful bacteria that may cause illness. In every step of food preparation, follow the four guidelines to keep food safe:

  • Clean—Wash hands and surfaces often.
  • Separate—Separate raw meat from other foods.
  • Cook—Cook to the right temperature.
  • Chill—Refrigerate food promptly.

Consumers with questions regarding the recall can contact Jennie-O Consumer Engagement Team at 1-800-621-3505, 8 a.m. to 4 p.m. Central Time Monday – Friday and 9 a.m. to 5 p.m. Central Time Saturday and Sunday. Media with questions can contact media@hormel.com or 507-434-6352.

Consumers with food safety questions can “Ask Karen,” the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: https://www.fsis.usda.gov/reportproblem.

FDA investigates contamination in raw Darwin’s Natural Pet and ZooLogics pet foods

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The FDA is alerting pet owners to a history of four recalls of and multiple complaints associated with Darwin’s Natural and ZooLogics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to February 10, 2018. In each instance, the company recalled these products after being alerted to positive findings of Salmonella and/or Listeria monocytogenes in samples of their raw pet food products.

As part of an ongoing investigation into complaints associated with products manufactured by Arrow Reliance/Darwin’s Natural of Tukwila, WA, the FDA has confirmed that new samples of Darwin’s Natural Pet Products raw pet foods have tested positive for Salmonella. These raw pet foods include ZooLogics Duck with Vegetable Meals for Dogs Lot #41957 and ZooLogics Chicken with Vegetable Meals for Dogs Lot #41567.

The latest recall was triggered by a complaint of an adult dog that had recurring diarrhea over a nine-month period. The dog tested positive for Salmonella from initial testing by the veterinarian and by follow-up testing by the FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN). The Darwin’s Natural raw pet food that the dog had been fed was also positive for Salmonella.

Arrow Reliance/Darwin’s Natural is aware of the dog’s illness and the positive results and initiated a recall on February 10, 2018 by directly notifying its customers via email. The firm has not issued a public recall notice.

Since October 2016, Arrow Reliance/Darwin’s Natural has initiated four recalls and had six reported complaints (some referring to more than one animal) associated with their raw pet food products, including the death of one kitten from a severe systemic Salmonella infection. The Salmonella isolated from the kitten was analyzed using whole genome sequencing and found to be indistinguishable from the Salmonella isolated from a closed package from the same lot of Darwin’s Natural cat food that the kitten ate.

In addition to reports of illnesses associated with Salmonella contamination in the products, the FDA is aware of complaints of at least three animals who were reportedly injured by bone shards in the Darwin’s Natural raw pet food products.

Since 2016, Arrow Reliance/Darwin’s Natural has recalled the following raw pet food products:

  • Darwin’s Natural Selections Duck with Organic Vegetables Meals for dogs, due to Salmonella
    Lot #40487, manufacture date 9/29/17, in 2 lb. flexible film packages, recalled on 12/04/17
  • Darwin’s Natural Selections Chicken with Organic Vegetables Meals for Dogs, due to Salmonella and Listeria Monocytogenes
    Lot #40727, manufacture date 9/26/17, in 2 lb. flexible film packages, recalled on 12/04/17
  • Darwin’s Natural Selections Turkey with Organic Vegetables Meals for Dogs, due to Salmonella
    Lot #39937, manufacture date 8/24/17 and Lot #40507, manufacture date 9/20/17, in 2 lb. flexible film packages, recalled on 12/04/17
  • Darwin’s Natural Selections Frozen Duck Meals for Cats, due to potential contamination with Salmonella
    Lot #38277, manufacture date 6/1/17, in 2 lb. flexible film packages, recalled on 09/08/17
  • Darwin’s Natural Selections Frozen Raw Beef with Organic Vegetables Meals for Dogs, due Listeria Monocytogenes
    Lot #3146070, manufacture date 7/21/16, in 2 lb. flexible film packages, recalled on 10/17/16
  • Darwin’s Natural Selections Frozen Raw Turkey with Organic Vegetables Meals for Dogs, due to Listeria Monocytogenes
    Lot #3142070, manufacture date 7/20/16, in 2 lb. flexible film packages, recalled on 10/17/16
  • ZooLogics Frozen Raw Turkey with Vegetable Meals for Dogs, due to Listeria monocytogenes
    Lot #3155070, manufacture date 7/25/16, in 2 lb. flexible film packages, recalled on 10/17/16

The recalled lot codes and the manufacturing dates are printed directly on the flexible film packages.

Arrow Reliance/Darwin’s Natural initiated each recall of the product lots by notifying customers directly via email. The company states that the raw pet foods are only sold online through direct-to-consumer sales.

This contaminated raw pet food is of particular public health importance because of the potential hazard to both human and animal health. Pets can get sick from Salmonella, but may also be carriers of the bacteria and can infect humans. Pets do not have to be apparently ill to be able to pass Salmonella onto their human companions.

People infected with Salmonella can develop diarrhea, fever and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.

Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Pets can pass Salmonella to humans without showing any signs of the illness themselves.

Raws For Paws Recalls Turkey Pet Food Because of Possible Salmonella Health Risk

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Raws for Paws of Minneapolis, MN is recalling approximately 4,000 pounds of its 5 lb. and 1 lb. chubs of Ground Turkey Pet Food because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The recalled Ground Turkey Pet Food was distributed throughout Minnesota, Wisconsin, and Iowa directly to consumers and through online mail orders.

The recalled product is packaged into 1-pound and 5-pound sealed plastic tubes, also known as chubs. The chubs are packaged into regular Turkey Pet Food cases and Pet Food Combo Pack cases, which contain a variety of pet food products. The products in question have case codes of 9900008, 9900009, 9900014, and 9900015. The manufacture date of Turkey Pet Food cases is 10/12/2017, and the manufacture dates of Combo Pack cases are between 10/12/2017 and 2/2/2018.

Two illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after testing by the Minnesota Department of Agriculture (MDA) revealed the presence of Salmonella in some packages of Turkey Pet Food.

Production of the product has been suspended while MDA and the company continue their investigation as to the source of the problem.

Consumers who have purchased Turkey Pet Food should discontinue the use of the product and contact Raws for Paws to determine if their product is subject to this recall and more information about disposal or return instructions. Consumers with questions may contact the company at 612-465-0372.

Redbarn Pet Products Issues Voluntary Recall of Dog Chews

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With an extreme abundance of caution, and with the care and concern of pets top of mind, Redbarn Pet Products, LLC of Long Beach, CA is voluntarily recalling a single product, Redbarn’s 7-inch Bully Stick three pack, because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. No illnesses, injuries or complaints have been reported.

The recalled products were distributed in pet specialty retail stores. Affected product comes in a 2.4 ounce, green plastic bag marked with an expiration date of 112120ABC stamped on the side. The product UPC is #7 85184 25105 8. You can see examples of the packaging here.

Redbarn takes the safety of pets and pet parents seriously. As company President Jeff Sutherland explained, “On 2/5/2018, we were notified by the Colorado Department of Agriculture that a single sample collected from a retail location detected Salmonella. At Redbarn, we test every product lot before it leaves our manufacturing plant. This lot code, expiry date 112120ABC, was tested both at our Redbarn lab and by a third-party testing facility. Those tests were negative for salmonella or pathogens. Despite not being able to replicate these test results or receiving any negative reports from customers regarding these chews, we feel the best course of action is to recall this lot code of the product and keep our customers safe”.

Consumers are encouraged to check the lot code to see if their product was affected. Pet owners who have this product matching this lot code in their homes are urged to discontinue use of the product. Consumers who purchased 7-inch Bully Stick multipacks with the affected lot code are urged to return them to the place of purchase for a full refund.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian. Again, no illnesses, injuries or complaints have been reported.

Family-owned Redbarn takes the safety of our product, pets, and customers as a number one concern. Redbarn employs an extensive Quality Assurance team that run over 400 safety tests on their products every week. Products like the 7-inch bully sticks are tested multiple times, for bacteria like Salmonella, coliforms and enteros. A product is declared safe to ship only after it tests negatively for these bacteria and other pathogens. As Sutherland explained “In issuing this voluntary recall, in conjunction with the FDA, we are standing by our core values of quality and integrity. At Redbarn, we do the right thing for our customers. That means that we hold ourselves to the highest safety and quality assurance standards and take all precautions to prevent situations like a recall from happening.”

Consumers with questions may contact the company via email at info@redbarninc.com or by phone at at 1-800-775-3849, M-F, 8am-5pm PST.

Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure

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The Zoll LifeVest 4000 is a wearable defibrillator used to treat life-threatening abnormal heartbeats (arrhythmias) in adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator. The LifeVest continuously monitors the patient’s heart and, if a fast, life-threatening heart rhythm is detected, the device delivers a treatment (i.e. a shock) to restore the patient to a normal heart rhythm.

FDA is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.” Failure to contact Zoll and immediately replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death of the patient because the device may fail to deliver therapy appropriately when needed.

Ideally, the LifeVest monitors the patient’s heart, delivering a “treatment shock” as needed to restore the patient’s heartbeat to a normal rhythm. However, FDA is aware that in certain cases the LifeVest 4000 may not be able to deliver a life-saving treatment shock to a patient due to a fault that prevents the device from charging its high-energy capacitors. During normal operation, this fault prompts the LifeVest to display “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102” on the device screen. The “Message Code 102” alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.

To date, FDA is aware of one patient death due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed. According to Zoll, as of November 14, 2017, there were a total of 33,670 devices distributed, with 24,975 devices distributed in the U.S. About 0.1% of the total devices distributed have displayed Message Code 102, which should only be remedied by immediate replacement of the device.

The FDA will continue to work with Zoll to monitor LifeVest 4000 devices for any adverse events related to Message Code 102 or a failure to deliver treatment. The FDA will also continue to work with Zoll to identify a permanent solution to the Message Code 102 issue, and will keep the public informed as new information becomes available.

RECOMMENDATION:
For Health care providers –

  • Train patients prescribed use of the Zoll LifeVest 4000 on how to identify the “Call for service, Message Code 102” alert. Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The alert will read “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” and will allow the patient to tap “OK” to return to normal operation.
  • Inform patients to respond to the “Call for service, Message Code 102” alert on the LifeVest 4000 screen by contacting Zoll immediately. Message Code 102 may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed. Zoll will replace the patient’s device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
  • Reinforce initial LifeVest 4000 training, explaining that the device can display messages on the screen and play audio alerts that require the patient to take action. If Message Code 102 does not appear on the device screen, the patient should continue to use the LifeVest 4000 as prescribed, and read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).

For Patients and Caregivers:

  • Contact Zoll immediately if “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” appears on your LifeVest 4000 screen. Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The Message Code 102 alert will also allow you to tap “OK” to return to normal operation.
    > However, the “Call for service, Message Code 102” alert may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed.
    > Zoll will replace your device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
  • Continue to use your LifeVest 4000 as prescribed by your physician and as instructed during your initial training if the “Call for service, Message Code 102” alert is NOT displayed on your device screen. You should continue to read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form 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