Device product
Amerigel Wound Dressing 55 gallons/drum
Z-1993-2014
Product summary
- Event
- Event 68488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 drums
- Official record key
device-enforcement:Z-1993-2014
Official wording
Reason: Product may not have been manufactured pursuant to a validated process protocol and CGMP.
Code information: 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.