B. Braun Medical recalls THERASPHERE ADMIN SET (Article No. 7M2:650) in Canada due to potential leakage causing therapy delays, bloodstream infections, and hazardous medication exposure.
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.
B. Braun Medical is recalling a specific type of sterile administration set used for radiation therapy in Canada. The set may leak, which could delay treatment, increase infection risk, and expose patients and healthcare workers to hazardous medication.
The administration set may leak due to a manufacturing issue. This leakage can delay therapy, increase the risk of bloodstream infections, and expose patients and healthcare workers to hazardous medication. In severe cases, it may require additional medical intervention.
Healthcare providers and patients using the THERASPHERE ADMIN SET for Yttrium-90 radiation therapy in Canada are affected. Those with the specific model number 7M2650 are most at risk.
Check for the model number 7M2650 on the THERASPHERE ADMIN SET. The product was sold in Canada and is sterile, single-use for Yttrium-90 radiation therapy.
Inspect the administration set for signs of leakage, which could indicate a manufacturing defect.
Reach out to your healthcare provider for guidance on whether to continue using the device or if a replacement is needed.
The recall indicates a potential leakage risk, so it is not safe to use without checking for leaks or following the manufacturer's guidance.
Look for the model number 7M2650 on the THERASPHERE ADMIN SET, which was sold in Canada for Yttrium-90 radiation therapy.
Check for leakage and contact your healthcare provider for instructions on whether to stop using it or get a replacement.
We’ve drafted a message you can send B. Braun Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0133-2024 — B. Braun Medical B. Braun Medical Hello, I own a B. Braun Medical that is covered by recall Z-0133-2024 from B. Braun Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
