# FDA recall Z-0227-2023

> **TELEFLEX LLC** · Class II · device recall initiated 2022-09-20.

## Product

Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116).  Urinary catheter.

## Reason for recall

Product may not be sterile

## Distribution

TN, CA, NC, TX, FL, OH, MO, IL, OR

## Key facts

- **Recall number:** Z-0227-2023
- **Recalling firm:** TELEFLEX LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-20
- **Report date:** 2022-11-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0227-2023

## Citation

> AI Analytics. FDA recall Z-0227-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0227-2023. Source: US FDA. Licensed CC0.

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