Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A — Class II medical device recall Z-1352-2023
Ongoing recall by Merit Medical Systems, Inc., reported 2023-04-19, distributed nationwide. Product that was built for design verification testing was inadvertently distributed to customers.
| Recall number | Z-1352-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2023-02-15 |
| Classified | 2023-04-07 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 17 devices |
| UPC / GTIN / UDI-DI | 00884450170069 |
| Lot numbers | CE-1400/A, H2586496 |
| Model numbers | CE-1400, CE-1400/A |
Product
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Reason for recall
Product that was built for design verification testing was inadvertently distributed to customers.
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-1352-2023. 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.