Therasphere Admin SET recall
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for…
Why was Therasphere Admin SET recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 5060116920635 Lot 0061790166
- Product
- THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for…
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 760 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)