FDA (Devices) recall action 98552
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
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.
B. Braun is recalling hemodialysis bloodlines with a 4.8 mm pump segment because small air bubbles can accumulate in the arterial line under negative pressure. 4,884 units are affected.
B. Braun is recalling StreamLine Bloodline Long Version sets because small air bubbles can accumulate in the arterial line under negative pressure. 328,640 units are affected.
B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG (Model Number: SL-2010M2096) because air bubbles may accumulate in the arterial line.
B. Braun is recalling StreamLine Bloodline Sets for Dialog DR because small air bubbles can accumulate in the arterial line under negative pressure. 3,158,104 units are affected.
B. Braun is recalling StreamLine Fresenius bloodlines supplied for DaVita because small air bubbles can accumulate in the arterial line under negative pressure. 1,174,271 units are affected.
B. Braun is recalling one model of hemodialysis bloodline because small air bubbles can accumulate in the arterial line when blood gases adhere to the tubing under negative pressure.