# FDA recall Z-0091-2023

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2022-09-15.

## Product

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.

## Reason for recall

The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications.  Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

## Distribution

Distribution US nationwide, Canada and Saudi Arabia.

## Key facts

- **Recall number:** Z-0091-2023
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-15
- **Report date:** 2022-10-26

- **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-0091-2023

## Citation

> AI Analytics. FDA recall Z-0091-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0091-2023. Source: US FDA. Licensed CC0.

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