FDA recall Z-0687-2020
Southwest Technologies Inc · Class II · device
Product
Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Reason for recall
Elasto-Gel Wound Dressing may be contaminated with mold.
Distribution
CA, GA, IL, KS, NY, OH, TN, TX, VA
Key facts
- Status
- Terminated
- Initiation date
- 2019-11-18
- Report date
- 2019-12-25
- Termination date
- 2024-08-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Kansas City, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0687-2020