Device product
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Z-3144-2024
Product summary
- 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
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.