FDA recall Z-0401-2019
Safe N Simple, LLC · Class II · device
Product
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Reason for recall
The sterilization process used was unqualified.
Distribution
CA
Key facts
- Status
- Terminated
- Initiation date
- 2018-08-22
- Report date
- 2018-11-14
- Termination date
- 2020-03-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Clarkston, MI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2019