FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
- Recall number
- Z-1145-2018
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
- Status
- Terminated
- Initiated
- 2017-09-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
- Root cause
- Mixed-up of materials/components
- Action
- On 09/20/17, an URGENT PRODUCT RECALL NOTICE was sent to all direct consignees via mail, informing them of a voluntary recall of specific lots of peritoneal dialysis catheters and catheter containing kits. Consignees were advised to immediately do the following: identify and quarantine effected devices; inform personnel to whom the devices were distributed of the field action; fill out and email the customer response form to response@merit.com within 5 days, and return effected devices within ten days using Federal Express account 112952756. Consignee questions were directed to phone: 801-208-4381 or fax: 801-316-4880. Sales representatives were sent an email communication informing them of the recall and instructing them to contact effected customers to help them return Customer Response Forms and product.
- Quantity
- 8
- Distribution
- United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
- Lot, serial or model codes
- Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932
- 510(k) numbers
- ["K031351"]
- PMA numbers
- not on file
- Product code
- OJV
- 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