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

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

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

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

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

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization. To date, there have been no reports of adverse events associated with this issue.

NEXTERONE is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which NEXTERONE is packaged.
Continue reading “Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter” »

Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter – Anaphylaxis and Other Serious Hypersensitivity Reactions

Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting—some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration.

Symptoms of anaphylaxis can include wheezing or difficulty breathing, swelling of the face or throat, hives or flushing, itching; abdominal cramping, abdominal pain or vomiting, back pain or chest pain, hypotension or shock.

BACKGROUND: Varubi (rolapitant) injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

RECOMMENDATION: Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.
It is advised that Healthcare professionals consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered Varubi (rolapitant) injectable emulsion.

Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with Varubi (rolapitant) injectable emulsion.

If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs,

  1. administration of Varubi (rolapitant) injectable emulsion should be stopped immediately.
  2. appropriate medical management (including epinephrine and or antihistamines) should be initiated, and
  3. Varubi (rolapitant) injectable emulsion should be permanently discontinued.

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:

  1. Complete and submit the report Online: www.fda.gov/MedWatch/report
  2. 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

See the Health Care Provider Letter for important prescribing information to reflect the new safety information.

ADM Animal Nutrition Recalls Rough-N-Ready Cattle Feed

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

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.

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

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.