—#166085

Product

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.

FDA product code: FJS — Catheter, Peritoneal, Long-Term Indwelling
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K970159
Affected lot / code info: Catalog Number: CF-5242 Lot Numbers: H1027245, H1038032, H1040946, H1063581, H1082840, H1117442, H845164, H879797, H936407, H980897, and H995076.

Why it was recalled

Mix-up between adult and pediatrics PD catheter.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2017-12-20
Terminated: 2020-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166085. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.