FDA (Devices) recall action 97854
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
The agency’s own wording, quoted from the enforcement report.
B. Braun Medical is recalling 23,160 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Foundation Medicine is recalling 59 FoundationOne CDx reports that were sent to customers without the companion diagnostic Claims Page.