Ongoing Class II Medical devices
- Recall started
- 28 May 2021
- Reason
- Dose audit failure after sterilization process
- Distribution
- Malaysia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2109-2021
- Stimulen Collagen Moisturizing Lotion, ST9555B
Kansas City, MO, United States
Southwest Technologies Inc recalls
3 recalls recorded since 2018, most recently on 28 May 2021. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 November 2019
- Terminated
- 23 August 2024
- Reason
- Elasto-Gel Wound Dressing may be contaminated with mold.
- Distribution
- CA, GA, IL, KS, NY, OH, TN, TX, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0687-2020
- Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Ongoing Class II Medical devices
- Recall started
- 28 December 2017
- 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.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1600-2018, Z-1602-2018, Z-1601-2018
- 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
- 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), SL300
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.