# FDA recall Z-1397-2025

> **B Braun Medical Inc** · Class II · device recall initiated 2025-02-17.

## Product

Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

## Reason for recall

Increased risk for valve housing detachment causing leakage.

## Distribution

Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.

## Key facts

- **Recall number:** Z-1397-2025
- **Recalling firm:** B Braun Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-17
- **Report date:** 2025-03-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1397-2025

## Citation

> AI Analytics. FDA recall Z-1397-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1397-2025. Source: US FDA. Licensed CC0.

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