Recall Z-0162-2015 ยท KRA Catheter, Continuous Flush
Merit Medical Systems, Inc.
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
| Date | Oct 31, 2014 (initiated Sep 26, 2014) |
| Status | Terminated |
| Reason | These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. |
| Root cause | Mixed-up of materials/components |
| Action | Consignees were notified via letter on September 26, 2014. Written notification included 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. An email notification was sent to US Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account, a representative copy of communication |
| Quantity | 56 units |
| Distribution | Nationwide and to India. No govt/military/VA consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082613 | MERIT MICROCATHETER Merit Medical Systems, Inc., Dec 30, 2008 |