TheraSphere Administration Set recallZ-0133-2024 · B. Braun Medical, Inc. · initiated Sep 26, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
On September 26, 2023, the firm notified customers via Urgent Product Recall Notification letters. Customers were informed of the potential for leakage at the male Luer lock site. Customers were instructed to report total amount of impacted product on hand to the firm, after which B Braun Customer Support will contact the customer with instructions on how to return the product for credit or replacement depending on the customer's need. Questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464.
Recall details
- Recall number
- Z-0133-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 26, 2023
- Posted by the FDA
- Nov 3, 2023
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 760 units
- Product code
- ONB
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
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.
Code information (models, lots, serial numbers)
UDI-DI: 5060116920635 Lot 0061790166
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TheraSphere Administration Set OTT-SPE-FP-001Biocompatibles Uk Ltd · Microspheres Radionuclide2 recalls2 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93074).
- Z-0128-2024 · Open, ClassifiedFT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
- Z-0129-2024 · Open, ClassifiedSA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
- Z-0130-2024 · Open, ClassifiedAMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
- Z-0134-2024 · Open, ClassifiedALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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