Class 2 Device Recall MEDALLION Syringe

• Date Initiated by Firm: October 22, 2010
• Date Posted: December 02, 2010
• Recall Status: Terminated on January 18, 2011
• Recall Number: Z-0505-2011
• Recall Event ID: 57102
• 510(K)Number: K994253
• Product Classification: Syringe, piston - Product Code FMF
• Product: Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
• Code Information: Lot Number: H166656
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 West Merit Parkway; South Jordan UT 84095
• For Additional Information Contact: 801-316-4932
• Manufacturer Reason for Recall: Packaging for syringes may have holes which would compromise the sterility of the package contents.
• FDA Determined Cause: Packaging process control
• Action: Merit Medical notified product managers of the product recall on October 22, 2010 following a voice mail script. Frequently Asked Questions, Sales Rep Letter, and Recall Notification Forms were then sent.. Sales reps were instructed to contact all of their customers and have them identify and quarantine any unused inventory and either return it to Merit or discard. A response form was to completed by the sales rep and the firm's representative, indicating amount of product quarantined, returned , or destroyed. Also, on 10/22/2010, authorized distributors were contacted by phone, mail, and / or fax. They were also provided a Distributor Letter, FAQs, and Recall Notification Forms instructing them to identify and quarantine any unused inventory and return it to Merit or discard. They were instructed to continue the recall to customers to whom they had shipped the affected Merit product. Additional information is available from Merit at 801-316-4822.
• Quantity in Commerce: 97 units
• Distribution: Worldwide Distribution: USA including the states of AL, CA, GA, OH, PA, TX, UT, and WA, and to the countires of Japan and UK.
• 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 = FMF