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-1602-2018
  • 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=162233
  • 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) 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
  • Distribution
    worldwide
  • Product Description
    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
  • 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