FDA (Devices) recall action 85514
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Potential disconnection of tubing set.
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 Healthcare is recalling 4,065 Gambro Cartridge Low Weight-Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.
Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential tubing disconnection hazard during hemodialysis treatment.
Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems due to a potential disconnection of the tubing set. The recall covers 53,895 units distributed worldwide.
Baxter Healthcare is recalling 19,800 Gambro Cartridge Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.