FDA-Device2022-06-08Class II
XVIVO Organ Chamber REF 19020
XVIVO PERFUSION AB
Hazard
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Sold states
U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
Affected count
80 devices
Manufactured in
Massans Gata 10, N/A, Goteborg, N/A, Sweden
Products
XVIVO Organ Chamber REF 19020
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1212-2022Don't want to check this manually?
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