FDA recall Z-0565-2021

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.

Reason for recall

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

Distribution

US Nationwide Foreign: Belgium, India

Key facts

Status

Terminated

Initiation date

2020-11-11

Report date

2020-12-23

Termination date

2021-11-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2021