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Recall Observatory FDA recall evidence

Device product

Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B

Z-1157-2023

November 18, 2022

Class II

Product summary

Firm
Cardinal Health 200, LLC
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

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect