Custom Dialysis Kit CF-4230 Without Gel — Class II medical device recall Z-1145-2018
Terminated recall by Merit Medical Systems, Inc., reported 2018-03-28. 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits
| Recall number | Z-1145-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2017-09-20 |
| Classified | 2018-03-20 |
| Reported by FDA | 2018-03-28 |
| Countries outside the US | AT, CH, DE, FI, GB, IE |
| Quantity | 8 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884450328613 |
| Lot numbers | H1190932 |
| Model numbers | K14-00078 |
| Expiration dates | 2020-07-31 |
Product
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Reason for recall
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1145-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.