# FDA recall Z-0133-2024

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2023-09-26.

## Product

THERASPHERE ADMIN SET, Article No. 7M2650. Canada only.  Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.

## Reason for recall

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication.  There is also the potential for life-threatening situations to occur requiring additional medical intervention.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

## Key facts

- **Recall number:** Z-0133-2024
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-26
- **Report date:** 2023-11-15

- **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-0133-2024

## Citation

> AI Analytics. FDA recall Z-0133-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0133-2024. Source: US FDA. Licensed CC0.

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