Tag Archives: Class I Recall

Medex Cardio-Pulmonary Recalls Sterile Saline and Sterile Water

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

Recalled Product(s):

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

Device Use

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

Reason for Recall

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

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

Who May be Affected

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

What to Do

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

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

The notice asked customers to:

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

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

Contact Information

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

Date Recall Initiated

September 5, 2017

Full List of Affected Devices

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

How do I report a problem?

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

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

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

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

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

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

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

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

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

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

Consumers with questions about the recall can contact Tyson Consumer Relations at 1-888-747-7611. Members of the Media with questions about the recall can contact Worth Sparkman, Senior Communications Manager with Tyson Foods, Inc., at (479) 290-6358.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

Schreiber Processing Corp. Recalls Chicken Tender Products

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A Class I Recall is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

WASHINGTON – Schreiber Processing Corp., a Maspeth, N.Y. establishment, is recalling approximately 2,330 pounds of chicken tender products that may be contaminated with plastic and misbranded, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The breaded chicken breast tenders were produced on December 8, 2016 and packaged on December 9, 2016. The following products are subject to recall:

10-lb. boxes containing “Meal Mart BATTERED & BREADED CHICKEN BREAST TENDERS” bearing item code 03-CTB and production code 0246

The products subject to recall bear establishment number “P-787” inside the USDA mark of inspection. These items were shipped to institutional and retail locations in New Jersey, New York, and Washington.

The problem was discovered after the firm received a consumer complaint.

There have been no confirmed reports of injury or illness due to consumption of these products. 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.

Consumers and media with questions about the recall can contact Mordechai Milworn, Q&A/HAACP Manager, at (718) 894-2000 ext. 336.

Tyson Foods Inc. Recalls Chicken Nugget Products

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WASHINGTON — Tyson Foods Inc., a Sedalia, Mo. establishment, is recalling approximately 132,520 pounds of fully cooked chicken nugget products that may be contaminated with hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

This is a Class I Recall which represents a health hazard where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

The fully cooked Panko Chicken Nuggets items were produced on July 18, 2016. The following products are subject to recall:
tyson-1

  • 5-lb. bag containing “Tyson FULLY COOKED PANKO CHICKEN NUGGETS” with a “Best If Used By” date of July 18, 2017 and case code 2006SDL03 and 2006SDL33.
  • 20-lb. bulk packages containing “SPARE TIME Fully Cooked, Panko Chicken Nuggets, Nugget Shaped Chicken Breast Pattie Fritters With Rib Meat” with a production date of July 18, 2016 and case code 2006SDL03.

tyson-2
The products subject to recall bear establishment number “EST. 13556” printed adjacent to the “Best If Used By” date on the back of the package. The 20-pound cases were shipped for institutional use in Pennsylvania and the five-pound bags were shipped to retail locations nationally.

The problem was discovered after the firm received consumer complaints regarding foreign material contamination of chicken nugget products. According to Tyson Foods, the plastic material ranged in size from 21mm in length and 6.5mm in diameter and may have come from a round, hard plastic rod used to connect a plastic transfer belt. The firm said the products pass through a metal detector, but the plastic is not detectable to this technology.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

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.

ConAgra Foods Recalls Frozen Chicken and Beef Products Due to Possible Foreign Matter Contamination

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ConAgra-3 ConAgra Foods, a Russellville, Ark. establishment, is recalling approximately 3,806 pounds of frozen chicken and beef entrée products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The metal fragments range in size between 2 and 9 millimeters (mm) in diameter, and are curled, malleable and shiny. The metal fragments may be embedded in the sauce contained within the frozen entrée products.

The frozen chicken and beef entrée items were produced on June 13, 2016 and June 22, 2016. The following products are subject to recall: [View Labels (PDF only)]

* 22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Brand Signature Spicy Chicken.” with “Use By” date of 6/08/17 and case code 5006616500.
* 22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Brand Mongolian Style Beef.” with “Use By” date of 6/17/17 and case code 5006617400.

The products subject to recall bear establishment number “EST. 233” or “EST. P-115” inside the USDA mark of inspection. These items were shipped to distributors and retail locations in Arkansas, Illinois, Michigan, Minnesota, New York, Vermont, and Wisconsin.

The problem was discovered July 1, 2016, when an establishment employee observed metal fragments while dispensing sugar from a supplier for sauce formulation during processing. The resulting sauce is a component in the frozen entrée products.

There have been no confirmed reports of adverse reactions or injuries due to consumption of these products. 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.

Nebraska Firm Recalls Pork Belly Product Produced Without Import Inspection

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WASHINGTON – Quality Meats, Inc., an Omaha, Neb., establishment, is recalling approximately 44,372 pounds of frozen pork belly product because they were not presented at the border for USDA-FSIS Import Inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. This is a Class I recall since the benefit of full inspection, a possibility of adverse health consequences exists.

Product subject to recall includes:

  1. Various weight cases of “rosderra IRISH MEATS Swine Pork Belly”

The Frozen Pork Single Ribbed Bellies product was packaged March 18, 2014 through April 10, 2014. The product subject to recall bears the Ireland establishment number “IE 356 EC.” This product was shipped to retail establishments and distributors in Georgia, Illinois, and Washington where the products would have been repackaged.

The problem was discovered during a routine review using the Automated Commercial Environment (ACE) database. ACE is a web-based portal for the collection and use of international trade data maintained by U.S. Customs and Border Protection.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

FSIS issues a Public Health Alert for an imported product when the country of origin recalls the product. FSIS issues a recall for imported product when the product is not presented for inspection at the U.S. border.

A failure-to-present (FTP) occurs when importers fail to present a shipment to FSIS for import inspection prior to the product entering U.S. commerce. Failure-to-present will result in the recall of the product.

Illinois Firm Recalls Chicken Products Due to Possible Salmonella Enteritidis Contamination

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Chicken-Kiev-Salmonella

Photo: Food Poisoning Bulletin web site.

WASHINGTON – Aspen Foods Division of Koch Meats, a Chicago, Il., based establishment, is recalling 28,980 pounds of chicken products that may be contaminated with a particular strain of Salmonella Enteritidis, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. FSIS requested Aspen Foods conduct this recall because this product is known to be associated with a specific illness cluster.

This is a Class I recall where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

The recalled product includes partially prepared chicken products sold by retailers under the Antioch Farms brand name, with “sell by” dates of October 1, 2015 and October 7, 2015. The products subject to recall bear the establishment number “P-1358” inside the USDA mark of inspection. The chicken products were produced on July 2, 2014 and July 8, 2014. These products were shipped to retail stores and distribution centers in Minnesota.

The product is identified as Single 5 once plastic packets of Raw Stuffed Chicken Breast Breaded, Boneless Breast of Chicken with Rib Meat “A La Kiev”

FSIS was notified of an investigation of Salmonella Enteritidis illnesses on October 9, 2014. Working in conjunction with Minnesota Department of Health, the Minnesota Department of Agriculture, and the Centers for Disease Control and Prevention, FSIS determined that there is a link between the Chicken Kiev from Aspen Foods Division of Koch Foods and this illness cluster. Based on epidemiologic investigation, 6 case-patients have been identified in Minnesota with illness onset dates ranging from August, 17, 2014 to September, 27, 2014. Among the 6 case-patients with available information, 1 case-patient was hospitalized; 0 deaths have been reported. All 6 case-patients reported chicken Kiev consumption prior to illness onset. Samples of product collected during the course of this investigation by Minnesota Department of Agriculture tested positive for Salmonella Enteritidis with the outbreak strain. It is not known at this time if this outbreak strain has any drug resistance. On October 17, 2014 FSIS received evidence that linked the illnesses associated with this outbreak to a specific product or production lot. Evidence that is required for a recall includes obtaining case-patient product that tests positive for the same particular strain of Salmonella that caused the illness, and packaging on product that clearly links the product to a specific facility and a specific production date, which were all met. FSIS is continuing to work with our public health partners on this investigation and will provide updated information as it becomes available.

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

FSIS reminds consumers to properly handle raw poultry in a manner to prevent contamination from spreading to other foods and food contact surfaces.

FSIS further reminds consumers of the critical importance of following package cooking instructions for frozen or fresh chicken products and general food safety guidelines when handling and preparing any raw meat or poultry. In particular, while cooking instructions may give a specific number of minutes of cooking for each side of the product in order to attain an 165 °F internal temperature, consumers should be aware that actual time may vary depending on the cooking method (broiling, frying or grilling) and the temperature of the product (chilled versus frozen), so it is important that the final temperature of 165 °F must be reached for safety. Do not rely on the cooking time for each side of the product, but use a food thermometer.