Z-1145-2018Class II

Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2...

Name: Z-1145-2018 Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2...
Creator: Merit Medical Systems, Inc.
Published: 2017-09-20
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2017-09-20 / Terminated / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078 on 2017-09-20. FDA classified it as Class II and gives the reason as "1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1145-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-20
Posted: 2018-03-20
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
Product code: OJV Single Use Instrument Tray
Reason for recall: 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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 in commerce: 8
Distribution: United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Product codes and lots: Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1145-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1143-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-20
Z-1144-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-20
Z-1145-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-20

Product code OJV

K031351Class IIFlex-Neck Pd Catheter, InfantMedigroup, Inc. / cleared 2003-09-17

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)