Z-0133-2024 Class II Ongoing
FDA device recall Z-0133-2024 was initiated by B. Braun Medical, Inc. on September 26, 2023 and is designated Class II. 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 ha… The recall status is ongoing. Affected quantity: 760 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- September 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 760 units
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.
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 Pattern
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Code Information
UDI-DI: 5060116920635 Lot 0061790166