FDA Enforcement
Class II
Ongoing
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Recall: Z-1347-2023
·
Reported April 12, 2023
Enforcement
- Recall Number
- Z-1347-2023
- Event ID
- 91775
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 12, 2023
- Initiation Date
- March 1, 2023
- Classification Date
- April 5, 2023
- Address
- 125 Blue Ball Rd, Elkton, MD, 21921-5315, United States
Description
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Reason
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.
Code Info
UDI-DI: (01)00699753450868; Lot Number AM03
Distribution
US Nationwide. Belgium, Canada, Costa Rica, Thailand.
Quantity
4940 units