FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: 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.
- Recall number
- Z-2823-2018
- 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.
- Status
- Terminated
- Initiated
- 2017-12-20
- Posted
- not on file
- Terminated
- 2020-10-29
- Reason
- Mix-up between adult and pediatrics PD catheter.
- 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.
- Quantity
- not on file
- 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
- Lot, serial or model codes
- Catalog Number: CF-5242 Lot Numbers: H1027245, H1038032, H1040946, H1063581, H1082840, H1117442, H845164, H879797, H936407, H980897, and H995076.
- 510(k) numbers
- ["K970159"]
- PMA numbers
- not on file
- Product code
- FJS
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28