medical Class II Updated 2020-12-23

Terumo Cardiovascular Systems Corporation recalls (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4

Recalled 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.

Hazard / Issue

Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: (1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837
View official government recall

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