Tag Archives: FDA

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,

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.

SCA Pharmaceuticals Issues Voluntary Nationwide Recall

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SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital level. The is a potential for the products to contain microbial contamination.

Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue, but out of an abundance of caution, is voluntarily initiating this recall.
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Infant Sleep Positioners: FDA Warning – Risk of Suffocation

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ISSUE: FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach. In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.

To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding.

BACKGROUND: The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.

RECOMMENDATION: Parents and other caregivers should not put babies in sleep positioning products.

  • NEVER use infant sleep positioners. Using this type of product to hold an infant on his or her side or back is dangerous.
  • NEVER put pillows, blankets, loose sheets, comforters, or quilts under a baby or in a crib. These products also can be dangerous. Babies don’t need pillows and adequate clothing—instead of blankets—can keep them warm.
  • ALWAYS keep cribs and sleeping areas bare. That means you should also never put soft objects or toys in sleeping areas.
  • ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “Alone on the Back in a bare Crib.”

ISSUE: FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach. In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.

To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding.

BACKGROUND: The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.

RECOMMENDATION: Parents and other caregivers should not put babies in sleep positioning products.

NEVER use infant sleep positioners. Using this type of product to hold an infant on his or her side or back is dangerous.
NEVER put pillows, blankets, loose sheets, comforters, or quilts under a baby or in a crib. These products also can be dangerous. Babies don’t need pillows and adequate clothing—instead of blankets—can keep them warm.
ALWAYS keep cribs and sleeping areas bare. That means you should also never put soft objects or toys in sleeping areas.
ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “Alone on the Back in a bare Crib.”

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

ADM Animal Nutrition Recalls Rough-N-Ready Cattle Feed

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ADM Animal Nutrition™, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 50-pound bags of Rough-N-Ready 14 BT cattle feed, product number 54787BHB24, because the product contains elevated levels of monensin beyond the recommended dosage, which could be harmful to cattle. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia, myoglobinuria, chronic cardiovascular issues, and possible death.

There is one lot number involved in this recall: Lot # 2WS01717. The product was distributed between Jan. 19, 2017, and Feb. 2, 2017, and could have been purchased directly from ADM Animal Nutrition or through one of three distributors including: Midwest Fertilizer, Inc. in Iola, Kansas; CW Feeds in Wichita, Kansas and Northtown Ace in Mountain Grove, Missouri.

ADM Animal Nutrition received reports from two customers claiming this feed may have resulted in death loss on their respective farms. The company immediately began investigating and initiated the recall upon receiving confirmation that the feed contained elevated levels of monensin due to a temporary breakdown in the packaging process, which has now been corrected. ADM has been in direct contact with the distributors involved in this recall, and all product has been removed from retail shelves. ADM is also working directly with the customers involved.

The lot number, 2WS01717, can be found at the bottom of the label. Customers who have purchased the recalled feed should immediately stop using it and return it to their distributor or directly to ADM Animal Nutrition for a full refund. Please direct any customer inquiries to 800-217-2007 between the hours of 8 a.m. and 4 p.m. Central Time Monday through Friday.

United Pet Group Expands Voluntary Recall of Multiple Brands of Rawhide Chew Products for Dogs

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United Pet Group, a division of Spectrum Brands, Inc. is voluntarily expanding its recall of multiple brands of packages of rawhide dog chew products to include our retail partners’ private label brands. The recall involves the brands and products described below.

United Pet Group previously initiated a voluntary recall of its branded products on 6/10/17 which included the following brands: American Beefhide, Digest-eeze, and Healthy Hide (including Healthy Hide – Good -n- Fun and Healthy Hide – Good -n- Fit).

The recall was initiated after  United Pet Group identified that certain of its rawhide chew manufacturing facilities located in Mexico and Colombia, as well as one of its suppliers in Brazil, were using a quaternary ammonium compound mixture as a processing aid in the manufacturing of rawhide chews. The compound is an anti-microbial chemical that is approved for cleaning food processing equipment, but it has not been approved in the U.S. as a processing aid in the production of rawhide chews for dogs.

United Pet Group received very limited reports of pet illness based on the volume of possibly affected rawhide chew products manufactured and distributed. The primary complaint received from consumers was that the affected product had an unpleasant odor. Diarrhea and vomiting were also reported.

Exposure to quaternary ammonium compounds through direct ingestion may cause the following symptoms in dogs: reduced appetite and gastric irritation, including diarrhea and vomiting. These symptoms may require treatment by a veterinarian depending on severity.

The affected product was distributed nationwide from United Pet Group’s Edwardsville, Illinois distribution facility and was delivered to consumers through various retail establishments, including online outlets. All of the dog chew products included in the voluntary recall identify an expiration date ranging from 06/01/2019 through 5/31/2020 located on the  back of the package with the exception of the Enzadent and Dentahex products which are listed by UPC codes below and specific expiration dates outlined below.

The private label products subject to the recall are described below.

Private Label Product Brands Private Label Product Names and Identifying Information
Companion United Pet Group is recalling certain packages of dog chews with the Companion brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by FOODHOLD U.S.A., LLC LANDOVER, MD 20785 1-877-846-9946
Dentley’s United Pet Group is recalling certain packages of dog chews with the Dentley’s brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Pacific Coast Distributing, Inc. 19601 N. 27th Ave. Phoenix, AZ USA 85027
Enzadent or Dentahex United Pet Group is recalling certain packages of dog chews with the Enzadent/Dentahex brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with the below listed UPC codes printed on the back of the package and which list expiration dates from 06/01/2021 through 05/31/2022 are affected by this recall. The following contact information appears on the back of the package of the affected products:

ENZADENT CHIPS MED 30 CT            17030030181
ENZADENT CHIPS PETITE 30 CT        17030030167
ENZADENT CHIPS SM 30 CT               17030030174
ENZADENT CHIPS LG 30 CT               17030030198
DENTAHEX CHIPS PETITE 30 CT       17030030228
DENTAHEX CHIPS SM 30 CT              17030030235
DENTAHEX CHIPS MED 30 CT            17030030242
DENTAHEX CHIPS LG 30 CT               17030030259

Manufactured for Vetoquinol USA Inc. Ft. Worth, TX USA 76137
Essential Everyday United Pet Group is recalling certain packages of dog chews with the Essential Everyday brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by SUPERVALU INC. EDEN PRAIRIE, MN 55344 USA
Exer-Hides United Pet Group is recalling certain packages of dog chews with the Exer-Hides brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716
Good Lovin’ or Petco United Pet Group is recalling certain packages of dog chews with the Good Lovin’ or Petco brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by: International Pet Supplies and Distribution, Inc. San Diego, CA 92121
Hill Country Fare United Pet Group is recalling certain packages of dog chews with the Hill Country Fare brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by H-E-B San Antonio, TX 78204
Priority Pet United Pet Group is recalling certain packages of dog chews with the Priority brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by Lucerne North America LLC
P.O. Box 99
Pleasanton, CA 94566-0009
1-866-578-4395

Consumers who have purchased the products described above are urged to dispose of the product or return it directly to United Pet Group or to the retail establishment where they initially purchased the product for full refund. Please see brand logos below which will assist in identifying affected products.

We take our responsibility to pets and their owners seriously and we are continuing to investigate the cause of this problem. We are implementing changes across  the  affected manufacturing facilities in order to prevent this problem from reoccurring in the future. United Pet Group is also working with retailers to ensure that the affected products are no longer sold and removed from inventory.

If you have these products, please contact the United Pet Group consumer affairs team at 1-855-215-4962 between the hours of 8:00 AM – 11:00 PM Eastern Standard Time for a refund.

Datascope recalls certain Intra-Aortic Balloon pumps.

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Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code.

AFFECTED PRODUCT PART NUMBER
CS100i IABP 0998-UC-0446HXX; 0998-UC-0479HXX
CS100 IABP 0998-00-3013-XX; 0998-UC-3013-XX
CS300 IABP 0998-00-3023-XX; 0998-UC-3023-XX

This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.

Overall Action for User
Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability. Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Please adhere to the following instructions when using affected devices:

  • Pursuant to the USER Instruction WARNINGS, clinicians are instructed not to leave the patient unattended during IABP therapy.
  • An additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. It is important to note the following WARNING in the CS100i, CS100 or CS300 IABP Operating Instructions Manual:

    WARNING: The patient balloon should not remain inactive in the patient (i.e., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.

  • Until the service is performed, we recommend powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.

Datascope has received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve.

There are approximately 12,000 affected units sold globally. The affected IABP units were distributed in the U.S. and worldwide (in over 100 countries). Affected units were distributed between March 23, 2003, and December 11, 2013. Units distributed after December 11, 2013, are not affected by the field correction.

A service representative from Datascope will be replacing the defective solenoid driver boards. Customers having affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service.

For additional information regarding this field correction, please contact the Customer Service Department at 1-888-627-8383 and Press 2 (Monday through Friday from 8:00 a.m. to 6:00 p.m. EDT).

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.

  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters

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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.