Z-1993-2014 Class II Terminated

Recalled by Kova Laboratories, Inc. — Margate, FL

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.