Events

Recall of Device Recall ElastoGel(TM)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Southwest Technologies Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78877
  • Event Risk Class
    Class 2
  • Event Number
    Z-1601-2018
  • Event Initiated Date
    2017-12-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162228
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    unknown device name - Product Code N/A
  • Reason
    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.
  • 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).

Device

Device Recall ElastoGel(TM)
  • Model / Serial
    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
  • Distribution
    worldwide
  • Product Description
    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
  • Manufacturer
    Southwest Technologies Inc

Manufacturer

Southwest Technologies Inc
  • Manufacturer Address
    Southwest Technologies Inc, 1746 E Levee St, Kansas City MO 64116-4404
  • Manufacturer Parent Company (2017)
    Southwest Technologies Inc.
  • Source
    USFDA