Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
FDA Recall Z-1509-2021 · Posted None
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Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2021-03-15
Date Terminated2022-06-07
Product Quantity1,900 units
Reason for Recall
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
Firm Action
On 03/12/2021, B. Braun issued an Urgent Medical Device Recall notice via letter notifying customers of the potential for the extension set to become occluded or unable to prime.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of NC, CA.
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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