Tag Archives: Recall

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.

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

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Click image for more labels

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

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

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

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

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

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

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. Consumers with questions regarding the recall can contact Jonathan Palmer, Customer Service Representative, at (601) 420-8847. Members of the media with questions regarding the recall can contact Brittany Mayer-Schuler, Vice President for Legal Affairs/General Counsel, at (866) 721-7859.

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

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

  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, EGG & BACON BURRITO with Cheddar Cheese, Potato, Green Chile, Salsa & Jalapeños” with case code of 833425000900.
  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, POBLANO CHICKEN BURRITO with Monterrey Jack Cheese, Salsa, Rice, Onion, Green Chile and Green & Red Bell Peppers” with case code of 833425000931.
  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, BEEF & POTATO BURRITO with Cheddar Cheese, Green Chile & Salsa” with case code of 833425000887.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, Chipotle Chicken Burrito with Salsa & Monterey Jack” with case code of 833425001426.

  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, CARNITAS Burrito with Salsa, Monterey Jack & Cilantro Lime Rice” with case code of 833425001488.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, EGG & SAUSAGE Breakfast Burrito with HASHBROWNS, Salsa, & Cheddar” with case code of 833425000382.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, EGG & BACON Breakfast Burrito with HASHBROWNS, Salsa, Green Chile & Cheddar” with case code of 833425000368.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, BEEF Burrito with POTATO, GREEN CHILE, Salsa & Cheddar” with case code of 833425000320.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, CHICKEN FAJITA Burrito with Salsa & Cheddar” with case code of 833425000429.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, SHREDDED STEAK Burrito with Salsa, Monterey Jack, Green Chile, Onion, Rice & Jalapeño Peppers” with case code of 10833425008941.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, BEEF & BEAN Burrito with Green Chile, Salsa & Cheddar” with case code of 833425000344.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, FIESTA Breakfast Burrito with Beef, Egg, HASHBROWNS, GREEN CHILE, Cheddar & Sausage” with case code of 833425000405.

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

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

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

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

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. Consumers with questions regarding the recall can contact Green Chile Concepts, Premiere Response Contact Center, at (800) 695-0843. Members of the media with questions regarding the recall can contact Greg Flack, CEO, at (952) 666-2995.

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

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

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

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

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

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

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

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

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

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

Trident Seafoods Corporation Recalls Frozen Multi-Grain Alaskan Cod

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

The following retail product is subject to the voluntary recall:

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

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

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

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

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

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

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

There have been no reports of injury or illness related to the recalled products to date, however anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. For additional information consumers can call Ms. Trev Foley, Consumer Affairs Manager, at 206-297-5825, Monday – Friday, 8 a.m. – 5 p.m. PST, or send email to trevf@tridentseafoods.com .

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

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

Below are the product descriptions and photographs:

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

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

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

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

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

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

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

ReFlow Medical Issues Recall of Specific Lots of Wingman35 Crossing Catheters

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

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

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

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

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

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

Consumers with questions may contact ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Pacific time or by email at info@reflowmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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

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

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

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

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

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

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

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

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

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

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

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

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