Reported Dec 23, 2020 · Terminated
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance
- Sterile Catalog Number3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir
- XC modified to Advance Catalog Number3CX*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
- Lot codes and dates
- (1)
- Lot NumberYD16 (2)
- Lot NumberYD23
- Unit GTIN Code(01)00699753450837
- Amount recalled
- 5,079 Total: 523 US and 4,556 OUS
Where it was sold
- Nationwide
Why it was recalled
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
This product could cause temporary or reversible health problems — stop using it.
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