# FDA recall Z-1352-2023

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2023-02-15.

## 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.

## Distribution

U.S. Nationwide distribution in the states of MD, MI, OH, and TX.  O.U.S.: N/A

## Key facts

- **Recall number:** Z-1352-2023
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-15
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2023

## Citation

> AI Analytics. FDA recall Z-1352-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1352-2023. Source: US FDA. Licensed CC0.

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