Recall Z-1212-2022— XVIVO PERFUSION AB

Name: FDA recall Z-1212-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-08

Class II · Terminated

Class II FDA medical device recall by XVIVO PERFUSION AB, initiated 2022-04-08, terminated 2025-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: XVIVO Organ Chamber REF 19020. Reason: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed..

Recalling firm: XVIVO PERFUSION AB
Classification: Class II
Status: Terminated
Initiated: 2022-04-08
Terminated: 2025-01-30
Firm location: Goteborg, N/A, Sweden

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.