Recalls / —

—#95408

Product

VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K994253

Affected lot / code info

Lot Number: H168038

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm

Merit Medical Systems, Inc.

Address

1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

Distribution pattern

Worldwide Distribution: USA including the states of AL, CA, GA, OH, PA, TX, UT, and WA, and to the countires of Japan and UK.

Timeline

Recall initiated

2010-10-22

Posted by FDA

2010-12-02

Terminated

2011-01-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #95408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.