Recall Z-0134-2024 ยท LCJ Tissue Expander And Accessories
B. Braun Medical, Inc.
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
| 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 | 27.432 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
| K853014 | MCGHAN TISSUE EXPANDER FILL KIT Mcghan Medical Corp., Sep 18, 1985 |