CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Reported: April 12, 2023 Initiated: March 1, 2023 #Z-1347-2023
Product Description
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Reason for Recall
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 4940 units
- Distribution
- US Nationwide. Belgium, Canada, Costa Rica, Thailand.
- Location
- Elkton, MD
Frequently Asked Questions
What product was recalled? ▼
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 4940 units.
Why was this product recalled? ▼
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 12, 2023. Severity: Moderate. Recall number: Z-1347-2023.
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