Z-0068-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- July 18, 2018
- Termination Date
- April 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
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 Pattern
US Distribution to state of: SC.
Code Information
Lot code: 00794-030718