FDA recall Z-0351-2023

Product

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

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

Key facts

Status

Terminated

Initiation date

2022-10-27

Report date

2022-12-21

Termination date

2024-10-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0351-2023