Device product
Amerigel Wound Dressing 1 oz. tube
Z-1992-2014
Product summary
- Event
- Event 68488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 122,396 / 1oz. tubes
- Official record key
device-enforcement:Z-1992-2014
Official wording
Reason: Product may not have been manufactured pursuant to a validated process protocol and CGMP.
Code information: Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.
Distribution pattern: Distributed in the states of FL and NJ.
Derived failure modes
-
Unknown
Product may not have been manufactured pursuant to a validated process protocol and CGMP.