FDA recall Z-0049-2020

Becton Dickinson & Company · Class II · device

Product

CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C

Reason for recall

After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.

Distribution

Nationwide Foreign: Canada

Key facts

Status: Terminated
Initiation date: 2019-05-02
Report date: 2019-10-16
Termination date: 2021-11-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0049-2020