HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008
FDA Recall Z-1602-2018 · Posted None
Recalling FirmSouthwest Technologies Inc
Recall StatusOpen, Classified
Product CodeN/A
Date Initiated2017-12-28
Product Quantity12352 units
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.
Firm Action
Southwest Technologies initiated their recall on December 28, 2017 by Certified Mail and expanded their recall to include international consignees on January 31, 2018 by Fed Ex. The consignees were requested to return or discard (US) and discard only (International).
Root Cause
Other
Distribution Pattern
worldwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.