Z-0351-2023 Class I Terminated

Recalled by ARROW INTERNATIONAL Inc. — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
December 21, 2022
Initiation Date
October 27, 2022
Termination Date
October 7, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
80 units

Product Description

Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

Reason for Recall

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

Distribution Pattern

US Distributor in states of: FL, GA, KY, OH, PA and WV.

Code Information

UDI/DI 10801902159448, Lot Number 13F22C0349