The Recall Desk
HighFDA (Devices)·Z-2823-2018·Announced 2018-08-22

Merit Medical Recalls Pediatric Peritoneal Dialysis Catheters Due to Mix-Up

Merit Medical Systems is recalling specific lots of Flex-Neck Classic Peritoneal Dialysis Catheters (Pediatric) due to a mix-up with adult catheters.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) in the absence of reported hospitalizations or injuries, as the hazard involves a product mix-up that may lead to incorrect device usage.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) because of a mix-up between adult and pediatric peritoneal dialysis catheters. The recall affects specific lots identified by catalog number CF-5242 and lot numbers H1027245, H1038032, H1040946, H1063581, H1082840, H1117442, H845164, H879797, H936407, H980897, and H995071.

The affected devices were distributed worldwide, including in the United States (specifically in AL, CA, DE, FL, KY, MA, MO, NC, NY, OH, PA, and UT) and Germany. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Patients and healthcare providers should check their inventory and patient records for the specific lot numbers listed above. If a patient has received one of these devices, they should contact their healthcare provider for further instructions regarding the recall.

The recalled product

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 implantati
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Dialysis Catheter
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

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

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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