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U.S. Department of Health and Human Services

Class 2 Device Recall ONQ Silver Dressing

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  Class 2 Device Recall ONQ Silver Dressing see related information
Date Initiated by Firm June 30, 2008
Date Posted November 29, 2011
Recall Status1 Terminated 3 on December 20, 2011
Recall Number Z-0306-2012
Recall Event ID 60192
510(K)Number K061232  
Product Classification Dressing, wound, drug - Product Code FRO
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.
Code Information Lot Numbers: H0705J (I-Flow Lots 17055 and 17054) and H0706J (I-Flow Lot 17054). Expiration date: 11/1/2008.    
Recalling Firm/
Manufacturer		 Acrymed Incorporated
9650 SW Nimbus Ave
Beaverton OR 97008-7171
For Additional Information Contact
503-624-9830
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRO and Original Applicant = ACRYMED, INC.
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