Recall Z-0129-2024— B. Braun Medical, Inc.

Name: FDA recall Z-0129-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-26

Class II · Ongoing

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2023-09-26. It names one FDA 510(k) clearance: K780551. Product: SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.. 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-26
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K780551 — I.V. ADMINISTRATION SET WITH MINI-SPIKENational Patent Development Corp.·cleared 1978-04-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.