Recall Z-0505-2011 ยท FMF Syringe, Piston
Merit Medical Systems, Inc.
Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
| Date | Dec 2, 2010 (initiated Oct 22, 2010) |
| Status | Terminated |
| Reason | Packaging for syringes may have holes which would compromise the sterility of the package contents. |
| Root 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994253 | VACLOK SYRINGE Merit Medical Systems, Inc., Jan 5, 2000 |