Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Reported: February 14, 2018 Initiated: January 3, 2018 #Z-0535-2018
Product Description
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Reason for Recall
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 2914 units
- Distribution
- DE, IA, CA and Japan
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.. Recalled by Medtronic Perfusion Systems. Units affected: 2914 units.
Why was this product recalled? ▼
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0535-2018.
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