B. Braun Medical, Inc.: Device Recall

Recall #Z-3144-2024 · 08/08/2024

Class II: Risk

Recall Details

Recall Number
Z-3144-2024
Classification
Class II
Product Type
Device
Recalling Firm
B. Braun Medical, Inc.
Status
Ongoing
Date Initiated
08/08/2024
Location
Allentown, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19050 units

Reason for Recall

Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.

Product Description

AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036

Distribution Pattern

US Nationwide distribution.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.