Home / Recalls / Medical Devices
XVIVO PERFUSION AB recalls XVIVO Organ Chamber REF 19020
Recalled June 8, 2022 · FDA recall Z-1212-2022 · XVIVO PERFUSION AB
Hazard
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. · FDA Class II
Units
80 devices
Sold at
U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
Description
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Product
XVIVO Organ Chamber REF 19020
Manufacturer(s)
XVIVO PERFUSION AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →