Use caution Medical device recall · FDA · Published December 28, 2017

Southwest Technologies Hypothermia Caps Recalled: Misbranded for Chemotherapy Use

Southwest Technologies recalls hypothermia caps (Elasto-Gel brands) misbranded for chemotherapy use. Two frostbite incidents reported in the last year. Consumers should check lot numbers for affected models.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1600-2018Medical device Southwest Technologies ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmSouthwest Technologies Inc1746 E Levee St · Kansas City, MO 64116-4404

✎ GovInfoNow plain-language explainer

Southwest Technologies has recalled hypothermia caps (Elasto-Gel brands) that are misbranded for use during chemotherapy. These products have been linked to frostbite injuries in users. The recall is due to improper labeling that could lead to unsafe use during cancer treatment. Read more at govinfonow.com/recall/72212-southwest-technologies-hypothermia-caps-recalled-misbranded-for-chemotherapy-use.

Source Summary by GovInfoNow · govinfonow.com/recall/72212-southwest-technologies-hypothermia-caps-recalled-misbranded-for-chemotherapy-use · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1600-2018

Cite this page

“Southwest Technologies Hypothermia Caps Recalled: Misbranded for Chemotherapy Use.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72212-southwest-technologies-hypothermia-caps-recalled-misbranded-for-chemotherapy-use. Based on FDA recall #Z-1600-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1600-2018%22&limit=1).

The FDA announced on Dec. 28, 2017, that Southwest Technologies Inc is recalling HYPOTHERMIA CAP Supportive in Cancer products due to misbranding for chemotherapy use. The agency classified the recall as Class II and ongoing.

How to tell if you have it

Brand: Elasto-Gel(TM)
Model: CAP610
Model: CAP610LV
Model: CAP613
Model: CAP617
Model: CAP619
Model: CAP619LV
Model: CAP622

The hazard

The hypothermia caps are misbranded for use during chemotherapy treatments. Southwest Technologies was informed of two events of frostbite to digits in the last year while using the hypothermia mitts.

Context

GovInfoNow's records show Southwest Technologies Inc has two other recalls on record since Nov. 18, 2019. On May 28, 2021, the company recalled Stimulen Lotion due to a dose audit failure risk after sterilization. On Nov. 18, 2019, Southwest Technologies Elasto-Gel Wound Dressings were recalled due to mold contamination risk. Other recent recalls of similar products include Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026), Windstone AMS Medical Kits Lidocaine Injection Recall (June 17, 2026), and Covidien Mon-a-Therm Stethoscope Recall (April 23, 2026).

How to tell if you have this one

Check for Elasto-Gel branded hypothermia caps with model numbers CAP610, CAP610LV, CAP613, CAP617, CAP619, CAP619LV, or CAP622. Look for specific lot numbers listed in the recall notice.

Brand
Southwest Technologies
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
worldwide

Recall number	Product, codes & lots	Quantity
Z-1600-2018	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; US distribution: (a) CAP610, Lot Numbers: 020613D 112912B 101312C 040813B 070213F 081513B 100113C 111413B 020314C 032516B 040514B 061014D 072214C 072214C 090914D 090914D 111814B 012115C 032715B 040915D 041615C 043015D 070915D 081815B 090115B 101215C 111315B 122115C 010616B 012116B 022316C 030116B 030515D 031016B 042516C 050616B 052016C 053116C 070816C 072516C 081216B 090216B 091416F 101316D (b) CAP610LV, Lot Numbers: 121912D 041013E 070813B 102413B 121913C 031414D 082014C 091615D OUS distribution: (a) CAP610, Lot Numbers: 011210B 012116B 020110B 020314C 022017B 022316C 030116B 030210B 030711D 032715B 040317C 040514B 040813B 042516C 043015D 050112C 052016C 053116C 060311B 070816C 070915D 072214C 072516C 072817d 081710B 082409B 090115B 091311B 101215C 101312C 101316D 111011B 111413B 111710C 111716L 111814B 112912B 172817d (b) CAP610LV, Lot Numbers: 050610D 091710B 120110B 030711C 040211D 062711C 091311C 031912E 051712C 091112C 102912B 121912D 041013E 070813B 102413B 121913C 031414D 070914C 082014C 110714C 121114C 010815D 041615D 051315C 061615B 091615D 112315B 012116C 021516B 040716B 041516B 052416B 072816B 091616C 101816B 013117C 022117D 030217C 032817D 050317B 071117D (c) CAP613, 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: 061212C 030513H 100113D 101713C 052114B 110714D 121114D 061515C 091715D 112315C 012116D 021516C 040716C 041516C 013117D 050317C 061217C (g) CAP622, Lot Numbers: 110210C	15666 units
Z-1601-2018	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) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012; 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: 090909C 102209C 031710D 050510D 080910B 010611B 031111C 090811D 100511C 060612D 101212B 110712D 020613C 070213E 101713B 031414C 063014D 092914C 101614B 012115D 050415D 111015D 020316B 042116D 101116D (b) TM7006LV, Lot Numbers: 022117B 032817B 050317D 061917D 071217C (c) TM7007, Lot Numbers: 032410D, 110210D (d) TM7008, Lot Numbers: 120709B 040210D 050610B 031111B 082311B 080911D 100511D 012512C 031912B 071212D 122612C 021813C 030513B 052213D 090313E 120613C 022714D 040114B 051414C 102714D 090814C 121614D 041015C 051815D 091115B 101715C 121015D 030316B 032116C 042016C 060116C 082316F 101116C 022017C 041817C (e) TM7009, Lot Numbers: 080510C 120211E 092012C 101013C 042215B 102616C (f) TM7010, Lot Numbers: 030110D (g) TM7011, Lot Numbers: 030110E (h) TM7012, Lot Numbers: 042110D	15434 units
Z-1602-2018	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; 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	12352 units

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number on the product packaging or label to determine if it is affected.

How this recall unfolded

Recall timeline

FDA published this recall 4 months after the firm started it.

Dec 28, 2017Firm started the recall
May 3, 2018FDA classified it Class II
May 9, 2018Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How do I know if I have an affected product?

Check the product model number and lot number against the list provided in the recall notice.

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Link to this recall

<a href="https://govinfonow.com/recall/72212-southwest-technologies-hypothermia-caps-recalled-misbranded-for-chemotherapy-use">Southwest Technologies Hypothermia Caps Recalled: Misbranded for Chemotherapy Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1600-2018 (December 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1600-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.