# FDA recall Z-2313-2021

> **Epimed International** · Class II · device recall initiated 2017-12-28.

## Product

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

## Reason for recall

Potential for stylet to protrude from the distal end of the catheter

## Distribution

Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV.  International distribution to Canada and Iran.

## Key facts

- **Recall number:** Z-2313-2021
- **Recalling firm:** Epimed International
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2017-12-28
- **Report date:** 2021-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Farmers Branch, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2313-2021

## Citation

> AI Analytics. FDA recall Z-2313-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-2313-2021. Source: US FDA. Licensed CC0.

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