Z-0133-2024Class II

THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to...

Name: Z-0133-2024 THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to...
Creator: B. Braun Medical, Inc.
Published: 2023-09-26
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2023-09-26 / Open, Classified / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal... on 2023-09-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0133-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-26
Posted: 2023-11-03
Recalling firm: B Braun Medical Inc
Product: 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 code: ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 760 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Product codes and lots: UDI-DI: 5060116920635 Lot 0061790166

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0133-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0128-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0129-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0130-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0131-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0132-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0133-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0134-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0135-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0136-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03

Product code ONB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)