FDA recall Z-0068-2019

Product

Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

Reason for recall

The device was built with the rigid insertion stylet instead of the flexible stylet.

Distribution

US Distribution to state of: SC.

Key facts

Status

Terminated

Initiation date

2018-07-18

Report date

2018-10-10

Termination date

2019-04-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2019