FDA Device recall Z-1352-2023
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
- FDA Device
- Class II
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class II recall of Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A by Merit Medical Systems, citing product that was built for design verification testing was inadvertently distributed to customers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1352-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-15 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Reason
Product that was built for design verification testing was inadvertently distributed to customers.
Identifiers
| code_info | Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1352-2023%22
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