Southwest Technologies recalls hypothermia caps (Elasto-Gel brands) misbranded for chemotherapy use. Two frostbite incidents reported in the last year. Consumers should check lot numbers for affected models.
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 has recalled hypothermia caps (Elasto-Gel brands) that are misbranded for use during chemotherapy. These products have been linked to frostbite injuries in users. The recall is due to improper labeling that could lead to unsafe use during cancer treatment.
The hypothermia caps are misbranded for chemotherapy use, meaning they are intended for cancer treatment but are not properly labeled. This mislabeling has led to two reported cases of frostbite in the last year when users were wearing the caps during chemotherapy.
People using hypothermia caps for chemotherapy treatments are affected. Those with cancer undergoing chemotherapy are most at risk due to potential frostbite injuries.
Check for Elasto-Gel branded hypothermia caps with model numbers CAP610, CAP610LV, CAP613, CAP617, CAP619, CAP619LV, or CAP622. Look for specific lot numbers listed in the recall notice.
Look for the lot number on the product packaging or label to determine if it is affected.
The caps are misbranded for use during chemotherapy treatments, which has led to two reported cases of frostbite in the last year.
No, the misbranded caps can cause frostbite injuries during chemotherapy treatments, so they should not be used.
Check the product model number and lot number against the list provided in the recall notice.
We’ve drafted a message you can send Southwest Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-1600-2018 — Southwest Technologies Southwest Technologies Hello, I own a Southwest Technologies that is covered by recall Z-1600-2018 from Southwest Technologies. 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.
