Z-1212-2022 Class II Terminated
FDA device recall Z-1212-2022 was initiated by XVIVO PERFUSION AB on April 8, 2022 and is designated Class II. Reason for recall: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. The recall status is terminated (terminated January 30, 2025). Affected quantity: 80 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2022
- Initiation Date
- April 8, 2022
- Termination Date
- January 30, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 devices
Product Description
XVIVO Organ Chamber REF 19020
Reason for Recall
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Distribution Pattern
U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
Code Information
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