🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 28, 2017 Southwest Technologies Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Southwest Technologies Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1601-2018

Related Recalls

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

Southwest Technologies

Class I - Dangerous

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.

Dec 28, 2017 Infusion Pumps View Details →