Device product
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Z-1158-2023
Product summary
- Event
- Event 91560
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36 EA
- Official record key
device-enforcement:Z-1158-2023
Official wording
Reason: Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
Code information: UDI-DI: 50195594381965(cs) 10195594381967(ea) Lot Number: 706265 Exp. Date: 5/1/2024
Distribution pattern: US Nationwide distribution in the states of GA, PA.
Derived failure modes
-
Manufacturing or process control
manufacturing defect