VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Recall
- Recall Number
- Z-0503-2011
- Event Number
- 57102
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 1721504
- Product Code
- FMF
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- October 22, 2010
- Posted
- December 2, 2010
- Terminated
- January 18, 2011
- Address
- 1600 West Merit Parkway, South Jordan, UT, 84095
Description
VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Packaging for syringes may have holes which would compromise the sterility of the package contents.
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.
Worldwide Distribution: USA including the states of AL, CA, GA, OH, PA, TX, UT, and WA, and to the countires of Japan and UK.
49 units