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U.S. Department of Health and Human Services

Class 2 Device Recall ElastoGel(TM)

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  Class 2 Device Recall ElastoGel(TM) see related information
Date Initiated by Firm December 28, 2017
Create Date May 03, 2018
Recall Status1 Open3, Classified
Recall Number Z-1601-2018
Recall Event ID 78877
Product Classification unknown device name - Product Code N/A
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
Code Information 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 
Recalling Firm/
Manufacturer		 Southwest Technologies Inc
1746 E Levee St
Kansas City MO 64116-4404
For Additional Information Contact John Phillips
816-221-2442
Manufacturer 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.
FDA Determined
Cause 2		 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
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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