The Recall Desk
HighFDA (Devices)·Z-1600-2018·Announced 2018-05-09

Southwest Technologies Recalls Misbranded Hypothermia Caps for Cancer Patients

Southwest Technologies is recalling hypothermia caps and other products misbranded for chemotherapy use, following reports of frostbite.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (frostbite) where injury has been reported, but the agency classification is Class II and no fatalities or hospitalizations are explicitly stated, fitting the 'High' criteria for injury reports without severe outcomes.

Plain-English summary

Southwest Technologies, Inc. is recalling Hypothermia Caps, Mitts, and Slippers, including specific Elasto-Gel models, because the products are misbranded for use during chemotherapy treatments. The recall involves 15,666 units distributed worldwide.

The FDA identified the misbranding issue and Southwest Technologies was informed of two events of frostbite to digits in the last year while using the hypothermia mitts. The affected products include various Elasto-Gel models such as CAP610, CAP610LV, CAP613, CAP617, CAP619, CAP619LV, and CAP622.

Consumers should stop using these products immediately and contact Southwest Technologies, Inc. for instructions on return or replacement. The recall covers units distributed in the United States and outside the US.

The recalled product

Product
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622
Manufacturer
Southwest Technologies Inc
Category
Medical Device — Cryotherapy / Temperature Regulation
Hazard
Affected units
15,666

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 (5)

  • US distribution: (a) CAP610
  • Lot Numbers: 093015B (d) CAP617
  • Lot Numbers: 080510D 120211D 092012D 101013B 042215C 102616B (e) CAP619
  • Lot Numbers: 062309B 051210C 091010C 101910C 112811E (f) CAP619LV
  • Lot Numbers: 110210C

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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