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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-1602-2018
Recall Event ID 78877
Product Classification unknown device name - Product Code N/A
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
Code Information 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 
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 12352 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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