SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
FDA Recall Z-0129-2024 · Posted 2023-11-03
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Recalling FirmB. Braun Medical, Inc.
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2023-09-26
Product Quantity17,100 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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