Merit Medical Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2823-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 20, 2017

Date Posted: August 22, 2018

Recall Number: Z-2823-2018

Event ID: 80651

Reason for Recall:

Mix-up between adult and pediatrics PD catheter.

Status: Terminated

Product Quantity:

Code Information:

Catalog Number: CF-5242 Lot Numbers: H1027245, H1038032, H1040946, H1063581, H1082840, H1117442, H845164, H879797, H936407, H980897, and H995076.

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

Voluntary or Mandated:

Voluntary: Firm initiated