The Recall Desk
SevereFDA (Devices)·Z-1601-2018·Announced 2018-05-09

Southwest Technologies Recalls Hypothermia Mitts, Slippers, and Caps for Misbranding

Southwest Technologies Inc. is recalling hypothermia mitts, slippers, and caps because they are misbranded for chemotherapy use and linked to two frostbite events.

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 to digits), which meets the criteria for a Severe rating (Score 4) involving significant injury reports.

Plain-English summary

Southwest Technologies Inc. is recalling Hypothermia Mitts, Hypothermia Slippers, and Hypothermia Caps. The products are packaged under the Elasto-Gel brand, including specific model numbers such as TM7006, TM7006LV, TM7007, TM7008, TM7008b, TM7009, TM7010, TM7011, and TM7012. A total of 15,434 units were distributed worldwide.

The recall was initiated because the products are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies Inc. was informed of two events of frostbite to digits in the last year while using the hypothermia mitts.

Consumers should stop using the affected products immediately. The recall covers specific lot numbers for US and outside-US distribution, which are detailed in the official FDA recall notice Z-1601-2018.

The recalled product

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)
Manufacturer
Southwest Technologies Inc
Category
Medical Device — Cold Therapy Devices
Hazard
Affected units
15,434

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 (20)

  • US distribution: (a) TM7006
  • Lot numbers: 060805B
  • 050415D (b) TM7008
  • Lot numbers: 031111B
  • 100511D
  • 012512C
  • 031912B
  • 071212D
  • 122612C
  • 021813C
  • 030513B
  • 031309D
  • 052213D
  • 090313E
  • 120613C
  • 022714D
  • 040114B OUS distribution: (a) TM7006
  • Lot Numbers: 022117B 032817B 050317D 061917D 071217C (c) TM7007
  • Lot Numbers: 032410D
  • 110210D (d) TM7008

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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