Class II — Southwest Technologies Inc
| Recalling firm | SOUTHWEST TECHNOLOGIES, INC. |
|---|---|
| Registered facility | SOUTHWEST TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012 |
| Quantity | 15434 units |
| Distribution | worldwide |
| Initiated | 2017-12-28 |
| Classified | 2018-05-03 |
| Recall number | Z-1601-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Southwest Technologies Inc (Z-1601-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78877/
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