FDA recall Z-1158-2023

Product

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

US Nationwide distribution in the states of GA, PA.

Key facts

Status

Ongoing

Initiation date

2022-11-18

Report date

2023-03-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1158-2023