Reported May 9, 2018 · Ongoing
HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b)…
Southwest Technologies Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Southwest Technologies Inc · 1746 E Levee St · Kansas City, MO · 64116-4404
Is this the product you have?
- 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
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Lot numbers: 060805B, 050415D (b) TM7008 2 Lot numbers: 031111B, 100511D, 012512C, 031912B, 071212D, 122612C, 021813C, 030513B, 031309D, 052213D, 090313E, 120613C, 022714D, 040114B OUS distribution: (a) TM7006 3 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 4 Lot Numbers: 022117B 032817B 050317D 061917D 071217C (c) TM7007 5 Lot Numbers: 032410D, 110210D (d) TM7008 6 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 7 Lot Numbers: 080510C 120211E 092012C 101013C 042215B 102616C (f) TM7010 8 Lot Numbers: 030110D (g) TM7011 9 Lot Numbers: 030110E (h) TM7012 10 Lot Numbers: 042110D - Amount recalled
- 15434 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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