Recall Z-0068-2019 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Surge Medical Sales, LLC (DBA Surge Cardiovascular)
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.
| Date | Jul 18, 2018 |
| Status | Terminated |
| Reason | The device was built with the rigid insertion stylet instead of the flexible stylet. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, MediSurge, contacted its customer via email on 7/18/18. The email described the product, problem and actions to be taken. If you have any questions, contact Director of Quality Assurance/Regulatory Affairs, at 616-202-6120 or email: kjonas@allianthealthcare.com. |
| Quantity | 35 units |
| Distribution | US Distribution to state of: SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964199 | CHASE CORONARY SINUS PERFUSION CANNULA Chase Medical, Inc., Mar 19, 1997 |