HYPOTHERMIA CAP Supportive in Cancer
Medical device recall Z-1600-2018. Published in FDA’s Enforcement Report on May 9, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 9, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 15666 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
15666 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,553 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 28, 2017.
- FDA classified it on May 3, 2018.
- FDA’s Enforcement Report published it on May 9, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Southwest Technologies Inc, of Kansas City, MO.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.