XVIVO Organ Chamber REF 19020
Reported: June 8, 2022 Initiated: April 8, 2022 #Z-1212-2022
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.
Details
- Recalling Firm
- XVIVO PERFUSION AB
- Units Affected
- 80 devices
- Distribution
- U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
- Location
- Goteborg, N/A
Frequently Asked Questions
What product was recalled? ▼
XVIVO Organ Chamber REF 19020. Recalled by XVIVO PERFUSION AB. Units affected: 80 devices.
Why was this product recalled? ▼
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1212-2022.
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