medical Class II Updated 2018-08-22

Merit Medical Systems, Inc. recalls Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric)

Recalled 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.


Hazard / Issue

Mix-up between adult and pediatrics PD catheter.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: CF-5242 Lot Numbers: H1027245, H1038032, H1040946, H1063581, H1082840, H1117442, H845164, H879797, H936407, H980897, and H995076.
View official government recall

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