Reported Jun 8, 2022 · Terminated
XVIVO Organ Chamber REF 19020
Xvivo Perfusion Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: XVIVO PERFUSION AB · Massans Gata 10 · Goteborg, N/A · N/A
Is this the product you have?
- XVIVO Organ Chamber REF 19020
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Barcodes Product as published 19020— — Lot Numbers/UDI Codes — 07350069520074LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 — 07350069520074LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 — 07350069520074LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 — 07350069520074LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 — 07350069520074LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 — 07350069520074LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806 - Amount recalled
- 80 devices
Where it was sold
Why it was recalled
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
This product could cause temporary or reversible health problems — stop using it.
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