ThermaCare Back Pain Therapy HeatWrap Recall [US]


ThermaCare Back Pain Therapy HeatWrap Recall [US]

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US FlagUS/Silver Spring: Pfizer Consumer Healthcare, a division of Pfizer Inc., a New York, New York establishment, recalls certain batch/lots of ThermaCare Back Pain Therapy HeatWraps due to suspected failure to higher cell temperature than specified and consequential risk of skin injuries such as burns, blisters and/or skin irritation on the exposed skin.

FDA: http://ht.ly/e5KJ30oyKxG

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-inc-issues-voluntary-nationwide-consumer-level-recall-one-lot-thermacarer-back-pain-therapy

Additional information:
The US Food and Drug Administration (“FDA”) reports the following HeatWrap products are subject to this recall:

  • ThermaCare Back Pain Therapy HeatWraps, rated at up to 16-hour pain relief, master batch/lot: S97473 with a UPC 305733010037 sold as Lower Back and Hip Therapy, 2-count carton and was used in the manufacturing of 17 retail display case sub lots.

Please note, the complete listing of all the recalled HeatWraps, including the carton/pouch master lot number, the retail display lot number, the retail display SKU and the retail display UPC, is available at the Web site identified above.

Please consult the photograph above for details of the product’s packaging, design and retail presentation.

According to the FDA, the recalled master lot and display case sub lots were distributed US nationwide to retailers, wholesalers and distributors in the United States including Puerto Rico from June 2017 through March 2018.

If you believe you have purchased or have in your possession any of the recalled HeatWrap products, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the HeatWraps to the store where you purchased it for a full refund.

==> To see other recalls and notifications caused by unsafe, dangerous HeatWrap products, please search for “wrap” or more generically, “medical” using the Search Box at the top of this page.

If you have any questions about this recall, please contact Pfizer Consumer Healthcare Information Line toll-free at 1-800-323-3383 from 9:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday.

Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online at http://www.fda.gov/medwatch/report.htm, by regular mail or by fax. You can download the applicable forms from the FDA Web site at http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. You can also submit the completed forms by fax to 1-800-FDA-0178.

==> To see other recalls and notifications caused by suspected Burn hazard, please search for “burn” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Pfizer Consumer Healthcare, please search for “Pfizer” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the ThermaCare brand name, please search for “ThermaCare” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 11405-2019
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe Meat, Poultry or Processed Egg product you purchased in the US [external: new window opens]:
==> https://ccms.fsis.usda.gov/
==> You can also all the toll-free USDA Meat and Poultry Hotline at 1-888-674-6854
Search for a recalled product on the USDA Web archive [external: new window opens]:
==> https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive

We welcome your feedback:
Want to e-mail or share this recall?
==> Simply use the “Share this” options below.
Is this recall relevant to you? Please let us know!
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E. & O. E.

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