CLASS II ONGOING Device recall · Reported 9 May 2018 · FDA Enforcement Report
Hypothermia Mitts Supportive in Cancer recalled
Southwest Technologies is recalling Hypothermia Mitts 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
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-1601-2018
- 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
- Other Medical Devices
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 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
Where it was distributed
worldwide
Questions about this recall
Is Hypothermia Mitts Supportive in Cancer, packaged under the following brands: (a) recalled?
Yes. Southwest Technologies recalled Hypothermia Mitts Supportive in Cancer, packaged under the following brands: (a) on 28 Dec 2017. The recall is Class II and its status is Ongoing. Recall number Z-1601-2018.
Why was it recalled?
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.
Which lots are affected?
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
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Southwest Technologies
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stimulen Collagen Moisturizing Lotion, ST9555B recalled | Southwest Technologies | Sterility | MO |
| Device | CLASS II | Elasto-Gel Absorbent Wound Dressing recalled by Southwest Technologies | Southwest Technologies | Mold | 9 states |
| Device | CLASS II | Hypothermia Slippers Supportive in Cancer recalled | Southwest Technologies | Labeling Errors | MO |
| Device | CLASS II | Hypothermia CAP Supportive in Cancer recalled by Southwest Technologies | Southwest Technologies | Labeling Errors | MO |
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