FDA recall Z-3144-2024

B. Braun Medical, Inc. · Class II · device

Product

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

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-08-08
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3144-2024