CLASS II ONGOING Device recall · Reported 9 May 2018 · FDA Enforcement Report

Hypothermia Slippers Supportive in Cancer recalled

Southwest Technologies is recalling Hypothermia Slippers Supportive in Cancer, packaged under the following brands: (a). The recall was initiated on 28 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUS 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

Quantity recalled12352 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1602-2018
FDA event ID: 78877
Recalling firm: Southwest Technologies, Kansas City, MO
Classification: Class II
Status: Ongoing
Recall initiated: 28 Dec 2017
FDA classified: 3 May 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Masks, Gloves & PPE

Timeline

28 Dec 2017	Recall initiated by company
3 May 2018	Classified by FDA	+126 days
9 May 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 78877

This product is part of a recall event; the main page for the event is Hypothermia CAP Supportive in Cancer recalled by Southwest Technologies.

Reported	Class	Recall	Company	Reason	Where
9 May 2018	CLASS II	Hypothermia CAP Supportive in Cancer recalled by Southwest Technologies	Southwest Technologies	Labeling Errors	MO
9 May 2018	CLASS II	Hypothermia Mitts Supportive in Cancer recalled	Southwest Technologies	Labeling Errors	MO

More recalls from Southwest Technologies

All 5

Reported	Class	Recall	Company	Reason	Where
28 Jul 2021Device	CLASS II	Stimulen Collagen Moisturizing Lotion, ST9555B recalled	Southwest Technologies	Sterility	MO
25 Dec 2019Device	CLASS II	Elasto-Gel Absorbent Wound Dressing recalled by Southwest Technologies	Southwest Technologies	Mold	9 states
9 May 2018Device	CLASS II	Hypothermia Mitts Supportive in Cancer recalled	Southwest Technologies	Labeling Errors	MO
9 May 2018Device	CLASS II	Hypothermia CAP Supportive in Cancer recalled by Southwest Technologies	Southwest Technologies	Labeling Errors	MO

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