Z-1993-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2014
- Initiation Date
- March 21, 2014
- Termination Date
- September 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 drums
Product Description
Amerigel Wound Dressing 55 gallons/drum
Reason for Recall
Product may not have been manufactured pursuant to a validated process protocol and CGMP.
Distribution Pattern
Distributed in the states of FL and NJ.
Code Information
Lot #3WD05.