Recall Z-1884-2021— Medtronic Perfusion Systems
Class II · Terminated
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2021-04-29, terminated 2023-03-20. It names one FDA 510(k) clearance: K171979. Product: Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.. Reason: Specific lots may have been manufactured with insufficient or incomplete welds..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-29
- Terminated
- 2023-03-20
- Firm location
- Brooklyn Park, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Reason for recall
Specific lots may have been manufactured with insufficient or incomplete welds.
Data sourced from openFDA. This site is unofficial and independent of the FDA.