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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-1600-2018
Recall Event ID 78877
Product Classification unknown device name - Product Code N/A
Product HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands:
(a) Elasto-Gel(TM), CAP610
(b) Elasto-Gel(TM), CAP610LV
(c) Elasto-Gel(TM), CAP613
(d) Elasto-Gel(TM), CAP617
(e) Elasto-Gel(TM), CAP619
(f) Elasto-Gel(TM), CAP619LV
(g) Elasto-Gel(TM), CAP622
Code Information US distribution: (a) CAP610, Lot Numbers:  020613D 112912B 101312C 040813B 070213F 081513B 100113C 111413B 020314C 032516B 040514B 061014D 072214C 072214C 090914D 090914D 111814B 012115C 032715B 040915D 041615C 043015D 070915D 081815B 090115B 101215C 111315B 122115C 010616B 012116B 022316C 030116B 030515D 031016B 042516C 050616B 052016C 053116C 070816C 072516C 081216B 090216B 091416F 101316D    (b) CAP610LV, Lot Numbers:  121912D 041013E 070813B 102413B 121913C 031414D 082014C 091615D   OUS distribution: (a) CAP610, Lot Numbers: 011210B 012116B 020110B 020314C 022017B 022316C 030116B 030210B 030711D 032715B 040317C 040514B 040813B 042516C 043015D 050112C 052016C 053116C 060311B 070816C 070915D 072214C 072516C 072817d 081710B 082409B 090115B 091311B 101215C 101312C 101316D 111011B 111413B 111710C 111716L 111814B 112912B 172817d  (b) CAP610LV, Lot Numbers: 050610D 091710B 120110B 030711C 040211D 062711C 091311C 031912E 051712C 091112C 102912B 121912D 041013E 070813B 102413B 121913C 031414D 070914C 082014C 110714C 121114C 010815D 041615D 051315C 061615B 091615D 112315B 012116C 021516B 040716B 041516B 052416B 072816B 091616C 101816B 013117C 022117D 030217C 032817D 050317B 071117D  (c) CAP613, Lot Numbers: 093015B  (d) CAP617, Lot Numbers: 080510D 120211D 092012D 101013B 042215C 102616B  (e) CAP619, Lot Numbers: 062309B 051210C 091010C 101910C 112811E  (f) CAP619LV, Lot Numbers: 061212C 030513H 100113D 101713C 052114B 110714D 121114D 061515C 091715D 112315C 012116D 021516C 040716C 041516C 013117D 050317C 061217C  (g) CAP622, Lot Numbers: 110210C 
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 15666 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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