ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Ea
FDA device recall Z-0306-2012 · posted 2011-11-29 · Terminated
Recall details
- Recalling firm
- Acrymed Incorporated
- Reason for recall
- The Silver Dressing, lot H0705J and H0706J may contain dressings that are not properly sealed in the foil pouch, which could affect sterility of the dressing.
- Action taken
- On June 30 2008, the firm e-mailed all affected customers with an Important Product Recall Notification letter. The customers were notified that two lots of SilverDressing may contain dressings that are not properly seated in the foil pouch. The customers were instructed to inspect the inventory, ceased distribution of the affected lots and quaratine the remaining inventory and notify AcryMed. Customers can call AcryMed at 503-624-9830 for any questions about this recall.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 14,125 units from lot # H0706J and 25,525 units from lot # H0705J
- Distribution
- Nationwide distribution -- DE, FL, KY, OR, IN, TX, NV, MT, CA and NY.
- Date initiated
- 2008-06-30
- Date posted
- 2011-11-29
- Date terminated
- 2011-12-20
- Location
- Beaverton, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 (K061232) | Acrymed, Inc. | 2006-10-06 |