B. Braun Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0133-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 26, 2023

Date Posted: November 15, 2023

Recall Number: Z-0133-2024

Event ID: 93074

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.

Status: Ongoing

Product Quantity: 760 units

Code Information:

UDI-DI: 5060116920635 Lot 0061790166

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated