Z-0306-2012

ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a...

Name: Z-0306-2012 ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a...
Creator: Acrymed Incorporated
Published: 2008-06-30
License: https://open.fda.gov/license/

Acrymed Incorporated / initiated 2008-06-30 / Terminated / root cause: manufacturing process

FDA source

Acrymed Incorporated began a recall of 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... on 2008-06-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0306-2012
Status: Terminated
Initiated: 2008-06-30
Posted: 2011-11-29
Terminated: 2011-12-20
Recalling firm: Acrymed Incorporated
Product: 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.
Product code: FRO Dressing, Wound, Drug
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: H0705J (I-Flow Lots 17055 and 17054) and H0706J (I-Flow Lot 17054). Expiration date: 11/1/2008.

Product code FRO

K061232UnclassifiedAcryderm Silver Antimicrobial Thin Film, Model 2006Acrymed, Inc. / cleared 2006-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)