Class II — Merit Medical Systems, Inc.
| Recalling firm | Merit Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits. |
| Product | Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck® Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078 |
| Quantity | 8 |
| Distribution | United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom |
| Initiated | 2017-09-20 |
| Classified | 2018-03-20 |
| Recall number | Z-1145-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merit Medical Systems, Inc. (Z-1145-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79426/
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