The FDA has issued an early alert regarding updated instructions for several Prismaflex and Oxiris dialysis tubing sets following a Vantive correction affecting units manufactured after mid-2024.
The change involves the deaeration chamber in Prismaflex Control Units, which may dislodge from its holder and trigger “Air in Blood” alarms. According to the March 16 FDA alert, the issue could lead to delays or interruptions in therapy and potential blood loss if clotting occurs.
Vantive issued a correction letter to affected customers Jan. 6 with revised usage instructions. The update does not involve device removal or a recall but advises clinicians to monitor chamber positioning during use and follow revised troubleshooting steps. The issue does not affect PrisMax Control Units.
The FDA said it has not received reports of serious injury or death associated with the issue as of Dec. 17. The alert applies to eight Prismaflex and Oxiris tubing set types manufactured after specified 2024 lot numbers.
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