Home / Recalls / Southwest Technologies Inc / Z-1601-2018

Z-1601-2018 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
15434 units

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

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) 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

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-1602-2018 Class II — HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (December 28, 2017)