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 adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
FDA Recall Z-0306-2012 · Posted 2011-11-29
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Recalling FirmAcrymed Incorporated
Recall StatusTerminated
Product CodeFRO
Date Initiated2008-06-30
Date Terminated2011-12-20
Product Quantity14,125 units from lot # H0706J and 25,525 units from lot # H0705J
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide distribution -- DE, FL, KY, OR, IN, TX, NV, MT, CA and NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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