FDA Recall
Terminated
Extra corporeal circuit with bio-active surface.
Recall: Z-2495-2020
·
Initiated August 8, 2018
Recall
- Recall Number
- Z-2495-2020
- Event Number
- 85821
- Firm
- Medtronic Perfusion Systems
- FEI Number
- 1000116158
- Product Code
- DTZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 8, 2018
- Terminated
- October 6, 2020
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088
Description
Extra corporeal circuit with bio-active surface.
Reason
Affected products failed a sterilization test.
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 [email protected]."
Distribution
Domestic Distribution only to CA and MI.
Quantity
10 units