CLASS II ONGOING Device recall · Reported 9 May 2018 · FDA Enforcement Report
Hypothermia CAP Supportive in Cancer recalled by Southwest Technologies
Southwest Technologies is recalling Hypothermia CAP 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-1600-2018
- 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 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
Where it was distributed
worldwide
Questions about this recall
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) 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
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hypothermia Slippers Supportive in Cancer recalled | Southwest Technologies | Labeling Errors | MO | |
| 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 |
|---|---|---|---|---|---|
| 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 Mitts Supportive in Cancer recalled | Southwest Technologies | Labeling Errors | MO |
| Device | CLASS II | Hypothermia Slippers Supportive in Cancer recalled | Southwest Technologies | Labeling Errors | MO |
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