Recall Z-0306-2012 ยท FRO Dressing, Wound, Drug
Acrymed Incorporated
ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adh
| Date | Nov 29, 2011 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061232 | ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 Acrymed, Inc., Oct 6, 2006 |