Recall Z-0133-2024 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
B. Braun Medical, Inc.
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
| Date | Nov 3, 2023 (initiated Sep 26, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 | 760 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.