Recall Z-0565-2021 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
(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 g
| Date | Nov 11, 2020 |
| Status | Terminated |
| Reason | Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) |
| Root cause | Labeling mix-ups |
| Action | Terumo issued URGENT Medical Device Removal letter on 11/11/2020 to all end users who have received potentially affected product via 2-day FedEx mailing. The letter states reason for recall, health risk and action to take: Remove of the Capiox FX25 Advance Reservoir/Oxygenator assembly from the cardboard box(es) but keep the unit within the sterile Tyvek pouch bag. " Review the label on the back of the reservoir to determine if the configuration is East or West. " Rotate the unit until the blood outlet port of the oxygenator is facing the observer (blood outlet port is evident by the red cap |
| Quantity | 5,079 Total: 523 US and 4,556 OUS |
| Distribution | US Nationwide Foreign: Belgium, India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenat Terumo Cardiovascular Systems Corporation, Nov 19, 2015 |