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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Merit Medical Systems, Inc.
- 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
Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Similar recalls
- HighMerit Medical Recalls Misconfigured Peritoneal Dialysis Catheters
FDA (Devices) · 2018-03-28
- ModerateMerit Medical Recalls Misconfigured Infant Peritoneal Dialysis Catheter Kits
FDA (Devices) · 2018-03-28
- HighMerit Medical Recalls Custom Dialysis Kits with Incorrect Catheter Configuration
FDA (Devices) · 2018-03-28
- HighMerit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure
FDA (Devices) · 2023-06-21
- HighFlex-Neck Catheter Repair Kit design test product inadvertently distributed to patients
FDA (Devices) · 2023-04-19
- HighFDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure
FDA (Devices) · 2023-06-21