Recall Z-1993-2014 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Kova Laboratories, Inc.
Amerigel Wound Dressing 55 gallons/drum
| Date | Jul 4, 2014 (initiated Mar 21, 2014) |
| Status | Terminated |
| Reason | Product may not have been manufactured pursuant to a validated process protocol and CGMP. |
| Root cause | Process control |
| Action | Kova Laboratories contacted customers with an URGENT: Medical Device Recall message by phone and e-mail 3/21/2014 and 4/21/2014, of the affected products to be returned. |
| Quantity | 3 drums |
| Distribution | Distributed in the states of FL and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971918 | AMERIGEL OINTMENT SATURATED WOUND DRESSING Amerx Health Care Corp., Aug 12, 1997 |