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
RecallTracker