Merit Kit recallZ-1144-2018 · Merit Medical Systems, Inc. · initiated Sep 20, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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.
Recall details
- Recall number
- Z-1144-2018
- Status
- Terminated
- Initiated by the company
- Sep 20, 2017
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 44
- Product code
- OJV
- FDA submissions
- K031351
- Distribution
- United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Product description
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
Code information (models, lots, serial numbers)
Lot #: a) H1190448, Exp 7/31/2020, UDI (01)00884450328620(17)200731(10)H1190448; b) H1193585, Exp 5/30/2019, UDI (01)00884450328620(17)190530(10)H1193585
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Merit® Kit 00884450328620Merit Medical Systems, Inc. · Dialysis administration kit1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 79426).
- Z-1143-2018 · TerminatedFlex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
- Z-1145-2018 · TerminatedCustom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page