Recall Z-2495-2020 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Extra corporeal circuit with bio-active surface.
| Date | Aug 8, 2018 |
| Status | Terminated |
| Reason | Affected products failed a sterilization test. |
| Root cause | Nonconforming Material/Component |
| Action | On August 8th Medtronic vervally communicated to the consignees to informed them about the situation and affected product. On August 20th they send a letter to the consignees stating that "as a result of the immediate verbal communication, your Medtronic representative has already retrieved the affected product from your facility. This notification is for your awareness and Medtronic requests that you complete and return the attached Customer Confirmation Certificate to RS.CFQFCA@Medtronic.com." |
| Quantity | 10 units |
| Distribution | Domestic Distribution only to CA and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE Medtronic Blood Systems, Inc., May 31, 1989 |