# FDA recall Z-0009-2023

> **B Braun Medical Inc** · Class II · device recall initiated 2022-09-01.

## Product

Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02.  A passive anti-needle device to provide venous or arterial access.

## Reason for recall

Potential for leakage at the catheter hub.

## Distribution

Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA.  Foreign distribution to Canada

## Key facts

- **Recall number:** Z-0009-2023
- **Recalling firm:** B Braun Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-01
- **Report date:** 2022-10-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Breinigsville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0009-2023

## Citation

> AI Analytics. FDA recall Z-0009-2023. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0009-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*