Southwest Technologies recalls Elasto-Gel hypothermia mitts (model TM7006-TM7012) due to frostbite risk during chemotherapy. Affected units include specific lot numbers from 2006-2017. Stop using immediately to avoid injury.
Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.
Southwest Technologies recalls Elasto-Gel hypothermia mitts and slippers for cancer patients that are misbranded for chemotherapy use. These products have been linked to frostbite injuries in users during treatment.
These products are mislabeled for chemotherapy use, meaning they're intended for cancer treatment but are actually designed for hypothermia management. This mismatch can cause frostbite injuries, as seen in two reported cases within the last year.
Cancer patients using chemotherapy who own Elasto-Gel hypothermia mitts, slippers, or caps with the listed model numbers and lot dates. Those with frostbite injuries from these products are at immediate risk.
Check for Elasto-Gel brand products with model numbers TM7006 through TM7012. Look for specific lot numbers listed in the recall notice, which range from 2006 to 2017.
Discontinue use of Elasto-Gel hypothermia mitts, slippers, or caps with the listed model numbers and lot dates to prevent frostbite injuries.
The products are misbranded for chemotherapy use, meaning they're intended for hypothermia management but are being used during cancer treatment, which can lead to frostbite injuries.
Affected models are TM7006 through TM7012 with specific lot numbers from 2006 to 2017 as listed in the recall notice.
Check the model number and lot number on your Elasto-Gel product against the list of affected models and lot numbers provided in the recall notice.
We’ve drafted a message you can send Elasto-Gel to request your refund or repair — edit it as you like.
Subject: Recall Z-1601-2018 — Elasto-Gel Elasto-Gel Hello, I own a Elasto-Gel that is covered by recall Z-1601-2018 from Elasto-Gel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
