Z-2104-2019 Class II Terminated
FDA device recall Z-2104-2019 was initiated by Terumo Cardiovascular Systems Corporation on June 14, 2019 and is designated Class II. Reason for recall: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component The recall status is terminated (terminated June 11, 2020). Affected quantity: 123 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- June 14, 2019
- Termination Date
- June 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 units
Product Description
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Reason for Recall
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Distribution Pattern
MI Foreign: Japan, Belgium
Code Information
Lot Numbers: XA21, XA29, XC04, XC18, XD05, XD27