Goteborg, N/A, Sweden
XVIVO PERFUSION AB recalls
1 recall recorded since 2018, most recently on 8 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 April 2022
- Terminated
- 30 January 2025
- Reason
- The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
- Distribution
- U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1212-2022
- XVIVO Organ Chamber REF 19020
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.