FDA Device recall Z-0133-2024
THERASPHERE ADMIN SET, Article No. 7M2650
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of THERASPHERE ADMIN SET, Article No. 7M2650 by B Braun Medical, citing 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 hea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0133-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-26 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 5060116920635 Lot 0061790166 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0133-2024%22
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