HYPOTHERMIA CAP Supportive in Cancer — Class II medical device recall Z-1600-2018
Ongoing recall by Southwest Technologies Inc, reported 2018-05-09. Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chem
| Recall number | Z-1600-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southwest Technologies Inc, Kansas City, MO, United States |
| Recall initiated | 2017-12-28 |
| Classified | 2018-05-03 |
| Reported by FDA | 2018-05-09 |
| Quantity | 15,666 units |
| Reason classes | labeling |
| Lot numbers | 010616B, 010815D, 011210B, 012115C, 012116B, 012116C, 012116D, 013117C, 013117D, 020110B, 020314C, 020613D, 021516B, 021516C, 022017B, 022117D, 022316C, 030116B, 030210B, 030217C, 030513H, 030515D, 030711C, 030711D, 031016B, 031414D, 031912E, 032516B, 032715B, 032817D, 040211D, 040317C, 040514B, 040716B, 040716C, 040813B, 040915D, 041013E, 041516B, 041516C and 90 more |
Product
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1600-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.