FDA Enforcement
Class II
Terminated
XVIVO Organ Chamber REF 19020
Recall: Z-1212-2022
·
Reported June 8, 2022
Enforcement
- Recall Number
- Z-1212-2022
- Event ID
- 90143
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- XVIVO PERFUSION AB
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 8, 2022
- Initiation Date
- April 8, 2022
- Classification Date
- June 1, 2022
- Termination Date
- January 30, 2025
- Address
- Massans Gata 10, N/A, Goteborg, N/A, N/A, Sweden
Description
XVIVO Organ Chamber REF 19020
Reason
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Code Info
Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806
Distribution
U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
Quantity
80 devices