FDA recall Z-2935-2018

Medical Components, Inc dba MedComp · Class II · device

Product

Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ

Reason for recall

The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

Distribution

Nationwide distribution; worldwide distribution.

Key facts

Status: Terminated
Initiation date: 2018-07-12
Report date: 2018-09-05
Termination date: 2020-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Harleysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2935-2018