# FDA recall Z-1733-2025

> **Galt Medical Corporation** · Class II · device recall initiated 2025-03-27.

## Product

B Braun Interventional ELITE HV Hemostasis Valve Introducer System  REF 612802  Model Number: BCL-100-04    The Elite HV¿ Introducer System is indicated for use in percutaneous  procedures to introduce catheters and other intravascular devices into the  vasculature.

## Reason for recall

Due to a potential open seal in the sterile barrier packaging .

## Distribution

Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

## Key facts

- **Recall number:** Z-1733-2025
- **Recalling firm:** Galt Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-27
- **Report date:** 2025-05-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1733-2025

## Citation

> AI Analytics. FDA recall Z-1733-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1733-2025. Source: US FDA. Licensed CC0.

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