medical Class II Updated 2018-05-09

Southwest Technologies Inc recalls HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under th

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: worldwide
Lot/Code Info: US Distribution: (a) SL3000, Lot Numbers: 110713C 122612D 091412C 070909D 052213E 080813D 020314D 031714D 071014B 101514B 120214B 011415B 030515C 041315C 071315C 091115C 100915C 020516D 030316D 041116D 060116B 062916C 081716B 101216D OUS Distribution: (a) SL3000, Lot Numbers: 102909D 070909D 011110C 030210C 042110D 050610C 080910C 100610D 011911C 031111D 060211C 080911C 100611B 012512B 031912C 061212D 091412C 110712B 122612D 052213E 080813D 110713C 020314D 031714D 071014B 101514B 120214B 011415B 030515C 041315C 071315C 091115C 100915C 020516D 030316D 040816B 041116D 060116B 081716B 101216D 013117B 022017D 041917C (b) SL3000LV, Lot Numbers: 022117C 032817C 050417B 061917C 071217B (c) SL3001, Lot Numbers: 032410C, 110210B (d) SL3007, Lot Numbers: 080510E, 102616D (e) SL3008, Lot Numbers: 030110C
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