# FDA recall Z-1144-2018

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2017-09-20.

## Product

Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

## Reason for recall

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.

## Distribution

United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom

## Key facts

- **Recall number:** Z-1144-2018
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-20
- **Report date:** 2018-03-28

- **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-1144-2018

## Citation

> AI Analytics. FDA recall Z-1144-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1144-2018. Source: US FDA. Licensed CC0.

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