The Recall Desk

FDA (Devices) recall action 78877

Southwest Technologies Inc recalled 3 products on 2018-05-09

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2018-05-09
Critical
0
Units
43,452

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2018-05-09

    Southwest Technologies Recalls Misbranded Hypothermia Caps for Cancer Patients

    Southwest Technologies is recalling hypothermia caps and other products misbranded for chemotherapy use, following reports of frostbite.

    Product
    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
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-09

    Southwest Technologies Recalls Hypothermia Mitts, Slippers, and Caps for Misbranding

    Southwest Technologies Inc. is recalling hypothermia mitts, slippers, and caps because they are misbranded for chemotherapy use and linked to two frostbite events.

    Product
    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…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-05-09

    Southwest Technologies Recalls Hypothermia Slippers Due to Misbranding and Frostbite Reports

    Southwest Technologies is recalling hypothermia slippers because they are misbranded for chemotherapy use and two frostbite events were reported.

    Product
    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
    Category
    Distribution
    0 states