medical Class II Updated 2023-11-15

B. Braun Medical, Inc. recalls THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Ste

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 5060116920635 Lot 0061790166
View official government recall

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