FDA (Devices) recall action 79687
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
The agency’s own wording, quoted from the enforcement report.
Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Becton Dickinson is recalling BD Vacutainer Ultra Touch Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.