Amerigel Wound Dressing 1 oz. tube
FDA device recall Z-1992-2014 · posted 2014-07-04 · Terminated
Recall details
- Recalling firm
- Kova Laboratories, Inc.
- Reason for recall
- Product may not have been manufactured pursuant to a validated process protocol and CGMP.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MGQ
- Quantity affected
- 122,396 / 1oz. tubes
- Distribution
- Distributed in the states of FL and NJ.
- Date initiated
- 2014-03-21
- Date posted
- 2014-07-04
- Date terminated
- 2016-09-12
- Location
- Margate, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMERIGEL OINTMENT SATURATED WOUND DRESSING (K971918) | Amerx Health Care Corp. | 1997-08-12 |