Medical DeviceJun 8, 2022
XVIVO Organ Chamber REF 19020 recall — FDA Z-1212-2022
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Class IIFDA: TerminatedXVIVO PERFUSION AB
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies XVIVO PERFUSION AB as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.