Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84

FDA device recall Z-0505-2011 · posted 2010-12-02 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

Packaging for syringes may have holes which would compromise the sterility of the package contents.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

FMF

Quantity affected

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.

Date initiated

2010-10-22

Date posted

2010-12-02

Date terminated

2011-01-18

Location

South Jordan, UT

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