Recall archive / FDA device enforcement
XVIVO Organ Chamber REF 19020 — FDA record Z-1212-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- XVIVO Organ Chamber REF 19020
- Reason
- The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
- Classification
- Class II
- Recalling firm
- XVIVO PERFUSION AB
- Quantity
- 80 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-1212-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 8, 2022
- Recall initiation date
- Apr 8, 2022
- Center classification date
- Jun 1, 2022
- Termination date
- Jan 30, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.