Xvivo Organ Chamber
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or Serial Number |
Model or catalog number |
|---|---|---|
Xvivo Organ Chamber |
13801 To 13806 |
19020 |
Issue
It has come to Xvivo knowledge that the sterile barrier (welded polybag) show defects in the weld for a number of batches of the Xvivo Organ Chamber. Defect was categorized as unsealed sections of the weld (compromised sterile barrier). To reinforce the instructions for use and emphasize the user to check the package in detail as described in the instructions for use, it was decided to issue a recall common to customers who have received devices for the batches affected.
Recall start date: Apr 11, 2022
Additional information
Details
Xvivo Perfusion Ab
Massans Gata 10, Goteborg
Sweden, 41251
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