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Recall Observatory FDA recall evidence

Device product

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

Z-3144-2024

August 08, 2024

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 95153
Status
Ongoing
Classification
Class II
Quantity
19050 units
Official record key
device-enforcement:Z-3144-2024

Official wording

Reason: 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.

Code information: Model No 472036; UDI-DI 04046964184659; Lots 0061898815, 0061905158, 00VL872690, 00VL882317 and 00VL882319

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.