B. Braun Medical, Inc. ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Brand
B. Braun Medical, Inc.
Lot Codes / Batch Numbers
UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770
Products Sold
UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770
B. Braun Medical, Inc. is recalling ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026