Z-1602-2018Class II

HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000...

Name: Z-1602-2018 HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000...
Creator: Southwest Technologies Inc
Published: 2017-12-28
License: https://open.fda.gov/license/

Southwest Technologies Inc / initiated 2017-12-28 / Open, Classified / root cause: labeling and UDI

FDA source

Southwest Technologies Inc began a recall of HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM)... on 2017-12-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1602-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-12-28
Posted: 2018-05-03
Recalling firm: Southwest Technologies Inc
Product: 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
Product code: N/A
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Southwest Technologies initiated their recall on December 28, 2017 by Certified Mail and expanded their recall to include international consignees on January 31, 2018 by Fed Ex. The consignees were requested to return or discard (US) and discard only (International).
Quantity in commerce: 12352 units
Distribution: worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1602-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1600-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1601-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1602-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-05-09	2018-05-03

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)