Device product
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.
Z-0565-2021
Product summary
- Event
- Event 86779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,079 Total: 523 US and 4,556 OUS
- Official record key
device-enforcement:Z-0565-2021
Official wording
Reason: Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
Code information: (1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837
Distribution pattern: US Nationwide Foreign: Belgium, India
Derived failure modes
-
Unknown
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)