Recall Z-1320-2014 ยท FMF Syringe, Piston
Merit Medical Systems, Inc.
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
| Date | Apr 3, 2014 (initiated Mar 13, 2014) |
| Status | Terminated |
| Reason | The products are labeled as sterile but were not sterilized. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative to arrange product return and replacement. For questions call 1-801-316-4822. |
| Quantity | 15 |
| Distribution | Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K875196 | DISPOSABLE CORONARY CONTROL SYRINGE 12CC Merit Medical Systems, Inc., Feb 11, 1988 |