FDA (Devices) recall action 83852
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
Baxter Healthcare is recalling Prismaflex Control Units with software versions below 7.21 because communication error alarms may interrupt therapy or cause blood loss.
Baxter Healthcare is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
Baxter Healthcare is recalling 336 Prismaflex Control Units with software versions below 7.21 due to communication error alarms that may interrupt therapy or cause blood loss.