XVIVO PERFUSION AB Recall 90143
Description: XVIVO Organ Chamber REF 19020
XVIVO PERFUSION AB Recall 90143 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1212-2022 |
| Event ID | 90143 |
| Event Description | XVIVO Organ Chamber REF 19020 |
| Product Type | Devices |
| Distribution | U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland |
| Quantity | 80 devices |
| Recall Reason | The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. |
| Device Classification | 20220608 |
| Device Code Info | 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 |
| Center Classification Date | 20220601 |
| Recall Initiation Date | 20220408 |
| Recalling Firm | XVIVO PERFUSION AB |
| Initial Notification | Letter |
| Similar To |