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 suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC System of peritoneoscopic implantation enable inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

Mix-up between adult and pediatrics PD catheter.

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 Response Form(s) applicable to their account(s). The sales representatives were instructed to assist their account(s) with the completion of the Customer Response Form(s) and the return of the affected units back to the Merit Field Assurance Department.