Recall Z-2495-2020
Medtronic Perfusion Systems · initiated August 8, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Extra corporeal circuit with bio-active surface.
Codes / lots: Lot# 215729283
Reason for recall
Affected products failed a sterilization test.
FDA-determined cause: Nonconforming Material/Component
Action taken
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."
Details
- Recall number
- Z-2495-2020
- Initiated
- August 8, 2018
- Terminated
- October 6, 2020
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Quantity
- 10 units
- Distribution
- Domestic Distribution only to CA and MI.
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN