Recall Z-2823-2018 ยท FJS Catheter, Peritoneal, Long-Term Indwelling
Merit Medical Systems, Inc.
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or sus
| Date | Dec 20, 2017 |
| Status | Terminated |
| Reason | Mix-up between adult and pediatrics PD catheter. |
| Root cause | Packaging process control |
| Action | Communication to consignees began on December 20, 2017. Written notification to Merit Accounts included product identification information, instructions to immediately quarantine any devices and discontinue use and return unopened product to Merit. Written notification to Merit Sales Representatives included product identification information and instructions to immediately return remaining Peritoneal Dialysis Catheter devices. An email notification was also sent to the Merit sales representatives of the affected accounts. The sales representatives were provided a copy of the Customer Respon |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, CA, DE, FL, KY, MA, MO, NC, NY, OH, PA, and UT and the countries of Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970159 | FLEX-NECK PD CATHETER Janin Group, Inc., Sep 5, 1997 |