Home / Recalls / XVIVO PERFUSION AB / Z-1212-2022

Z-1212-2022 Class II Terminated

Recalled by XVIVO PERFUSION AB — Goteborg, N/A

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