Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a...
FDA Recall #Z-2823-2018 — Class II — December 20, 2017
Product Description
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.
Reason for Recall
Mix-up between adult and pediatrics PD catheter.
Recalling Firm
Merit Medical Systems, Inc. — South Jordan, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
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
Code Information
Catalog Number: CF-5242 Lot Numbers: H1027245, H1038032, H1040946, H1063581, H1082840, H1117442, H845164, H879797, H936407, H980897, and H995076.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated