Z-1601-2018Class II

HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b)...

Name: Z-1601-2018 HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b)...
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 MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007... 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-1601-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-12-28
Posted: 2018-05-03
Recalling firm: Southwest Technologies Inc
Product: 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
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: 15434 units
Distribution: worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1601-2018
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)