FDANovember 11, 2020device
(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 Oxy...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
What to do
FDA enforcement status: Terminated
Brands named
terumo cardiovascular systemsterumoterumo cardiovascular
UPCs
00699753450837
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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