FDAFDA · Food and drugs·Recall number Z-0565-2021
(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.
Published December 23, 2020 · Recall initiated: November 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- US Nationwide Foreign: Belgium, India
- Lot
- (1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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