Device product
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Z-1157-2023
Product summary
- Event
- Event 91560
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4560 EA
- Official record key
device-enforcement:Z-1157-2023
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: 50195594577153(cs) 10195594577155(ea) Lot Number: 816643 Exp. Date: 2/1/2025
Distribution pattern: US Nationwide distribution in the states of GA, PA.
Derived failure modes
-
Manufacturing or process control
manufacturing defect