Device product

XVIVO Organ Chamber REF 19020

Z-1212-2022

April 08, 2022

Class II

Product summary

Firm: XVIVO PERFUSION AB
Event: Event 90143
Status: Terminated
Classification: Class II
Quantity: 80 devices
Official record key: device-enforcement:Z-1212-2022

Official wording

Reason: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

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

Distribution pattern: U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

seal of the primary pouch was incomplete, and the sterility