Home / Recalls / Southwest Technologies Inc / Z-1602-2018

Z-1602-2018 Class II Ongoing

Recalled by Southwest Technologies Inc — Kansas City, MO

Recall Details

Product Type
Devices
Report Date
May 9, 2018
Initiation Date
December 28, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12352 units

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

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.

Distribution Pattern

worldwide

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

Other recalls by Southwest Technologies Inc

  • Z-2109-2021 Class II — Stimulen Collagen Moisturizing Lotion, ST9555B (May 28, 2021)
  • Z-0687-2020 Class II — Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile (November 18, 2019)
  • Z-1600-2018 Class II — HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) (December 28, 2017)
  • Z-1601-2018 Class II — HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a (December 28, 2017)