# FDA recall Z-1509-2021

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2021-03-15.

## Product

Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.

## Reason for recall

BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.

## Distribution

US Nationwide distribution in the states of NC, CA.

## Key facts

- **Recall number:** Z-1509-2021
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-15
- **Report date:** 2021-05-05
- **Termination date:** 2022-06-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1509-2021

## Citation

> AI Analytics. FDA recall Z-1509-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1509-2021. Source: US FDA. Licensed CC0.

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