Device product
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Z-0401-2019
Product summary
- Event
- Event 81150
- Status
- Terminated
- Classification
- Class II
- Quantity
- 125 cases
- Official record key
device-enforcement:Z-0401-2019
Official wording
Reason: The sterilization process used was unqualified.
Code information: lot number 18060564
Distribution pattern: CA
Derived failure modes
-
Unknown
The sterilization process used was unqualified.