FDA recall Z-1212-2022

XVIVO PERFUSION AB · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2022-04-08
Report date
2022-06-08
Termination date
2025-01-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Goteborg, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1212-2022