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.

SCA Pharmaceuticals Issues Voluntary Nationwide Recall

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.
Continue reading “SCA Pharmaceuticals Issues Voluntary Nationwide Recall” »

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.

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

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

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.