Z-2823-2018Class II

Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric)

Name: Z-2823-2018 Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric)
Creator: Merit Medical Systems, Inc.
Published: 2017-12-20
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2017-12-20 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The... on 2017-12-20. FDA classified it as Class II and gives the reason as "Mix-up between adult and pediatrics PD catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2823-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Posted: 2018-08-15
Terminated: 2020-10-29
Recalling firm: Merit Medical Systems, Inc.
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.
Product code: FJS Catheter, Peritoneal, Long-Term Indwelling
Reason for recall: Mix-up between adult and pediatrics PD catheter.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Communication to consignees began on December 20, 2017. Written notification to Merit Accounts included product identification information, instructions to immediately quarantine any devices and discontinue use and return unopened product to Merit. Written notification to Merit Sales Representatives included product identification information and instructions to immediately return remaining Peritoneal Dialysis Catheter devices. An email notification was also sent to the Merit sales representatives of the affected accounts. The sales representatives were provided a copy of the Customer Response Form(s) applicable to their account(s). The sales representatives were instructed to assist their account(s) with the completion of the Customer Response Form(s) and the return of the affected units back to the Merit Field Assurance Department.
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
Product codes and lots: Catalog Number: CF-5242 Lot Numbers: H1027245, H1038032, H1040946, H1063581, H1082840, H1117442, H845164, H879797, H936407, H980897, and H995076.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2823-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2823-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-14

Product code FJS

K970159Class IIFlex-Neck Pd CatheterJanin Group, Inc. / cleared 1997-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)