FDA Device recall Z-1212-2022
XVIVO Organ Chamber REF 19020
- FDA Device
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of XVIVO Organ Chamber REF 19020 by Xvivo Perfusion Ab, citing the weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1212-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-08 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Xvivo Perfusion Ab |
| Distribution | CA, FL, MA, NC, NY, OH, PA, TX |
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.
Identifiers
| code_info | Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1212-2022%22
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