Z-1158-2023 Class II Ongoing
FDA device recall Z-1158-2023 was initiated by Cardinal Health 200, LLC on Nov 18, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 36 EA.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 1, 2023
- Initiation Date
- Nov 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 EA
Product Description
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the states of GA, PA.
Code Information
UDI-DI: 50195594381965(cs) 10195594381967(ea) Lot Number: 706265 Exp. Date: 5/1/2024
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1158-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026