Recall Z-1319-2014 ยท OBI Catheter, Pressure Monitoring, Cardiac
Merit Medical Systems, Inc.
Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
| 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 | 80 |
| 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
| K883718 | MERIT HI-FLEX(TM) Merit Medical Systems, Inc., Jan 30, 1989 |