XVIVO PERFUSION AB recalls XVIVO Organ Chamber REF 19020
- Recall date
- April 8, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1212-2022
- FDA classification
- Class II
- Brand / firm
- XVIVO PERFUSION AB
- Sold / distributed
- U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
Why it was recalled
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
XVIVO Organ Chamber REF 19020
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