FDA Enforcement
Class II
Terminated
(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.
Recall: Z-0565-2021
·
Reported December 23, 2020
Enforcement
- Recall Number
- Z-0565-2021
- Event ID
- 86779
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 23, 2020
- Initiation Date
- November 11, 2020
- Classification Date
- December 14, 2020
- Termination Date
- November 22, 2021
- Address
- 6200 Jackson Rd, N/A, Ann Arbor, MI, 48103-9586, United States
Description
(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.
Reason
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
Code Info
(1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837
Distribution
US Nationwide Foreign: Belgium, India
Quantity
5,079 Total: 523 US and 4,556 OUS