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STEEN Solution™
Xvivo Perfusion AB · Model 19004 · UDI-DI 07350069520036
0
510(k) clearances
8
Adverse events
1
Recalls
13
Facilities
Description
STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-08 | XVIVO PERFUSION AB | The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.