(1) Capiox FX25 recall
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox…
Why was (1) Capiox FX25 recalled?
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837
- Product
- (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 5,079 Total: 523 US and 4,556 OUS
- Distribution
- US Nationwide Foreign: Belgium, India
- Recall date
- December 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)