Terumo Capiox FX25 Advance Oxygenator Recall for Configuration Error
Terumo is recalling Capiox FX25 Advance Oxygenators because they may have the incorrect East or West configuration. The recall affects 5,079 units distributed in the US and abroad.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used in surgery where a configuration error poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Capiox FX25 Advance Oxygenators, including specific East and West configurations with 4-liter reservoirs. The recall is issued because the devices may be the incorrect configuration (East vs. West) for the intended surgical setup. These oxygenators are intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.
The recall involves a total of 5,079 units, with 523 distributed in the United States and 4,556 distributed outside the US. Distribution in the US was nationwide, while foreign distribution included Belgium and India. The affected lots are identified by Lot Numbers YD16 and YD23, and the unit GTIN Code is (01)00699753450837.
Healthcare providers and facilities should check their inventory for these specific catalog numbers and lot numbers. If the devices are found, they should be removed from use and returned to Terumo Cardiovascular Systems Corporation according to the company's instructions. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- 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*FX25R
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- (1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837
Distribution
Distributed nationwide across the United States.
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