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Terumo Cardiovascular Systems Corporation recalls (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog
Recalled December 23, 2020 · FDA recall Z-0565-2021 · Terumo Cardiovascular Systems
Hazard
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) · FDA Class II
Units
5,079 Total: 523 US and 4,556 OUS
Sold at
US Nationwide Foreign: Belgium, India
Description
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
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.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →