The Recall Desk
SevereFDA (Devices)·Z-1602-2018·Announced 2018-05-09

Southwest Technologies Recalls Hypothermia Slippers Due to Misbranding and Frostbite Reports

Southwest Technologies is recalling hypothermia slippers because they are misbranded for chemotherapy use and two frostbite events were reported.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reported injuries (frostbite), which aligns with the rubric criteria for a Severe rating (FDA Class II with injury reports).

Plain-English summary

Southwest Technologies, Inc. is recalling Hypothermia Slippers, packaged under the Elasto-Gel brand, due to misbranding and reported adverse events. The product is misbranded for use during chemotherapy treatments. Additionally, the manufacturer was informed of two events of frostbite to digits in the last year while using the hypothermia mitts.

The recall involves 12,352 units distributed worldwide. Affected products include the Elasto-Gel SL3000, SL3000LV, SL3001, SL3007, and SL3008 models. Specific lot numbers for US and outside-US distribution are listed in the official recall notice.

Consumers should stop using the recalled products immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

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
Manufacturer
Southwest Technologies Inc
Category
Medical Device — Thermal Therapy
Hazard
Affected units
12,352

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • US Distribution: (a) SL3000
  • Lot Numbers: 022117C 032817C 050417B 061917C 071217B (c) SL3001
  • Lot Numbers: 032410C
  • 110210B (d) SL3007
  • Lot Numbers: 080510E
  • 102616D (e) SL3008
  • Lot Numbers: 030110C

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Southwest Technologies Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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