CAPIOX FX25 Hollow Fiber Oxygenator recall
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Why was CAPIOX FX25 Hollow Fiber Oxygenator 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)00699753450868; Lot Number AM03
- Product
- CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 4940 units
- Distribution
- US Nationwide. Belgium, Canada, Costa Rica, Thailand.
- Recall date
- April 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)