FDA (Devices) recall action 71883
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.
The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.
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.
Becton Dickinson is recalling 770 units of Enterococcus Screen Agar QUAD Plates due to potential breakthrough growth of Enterococcus faecalis near the end of shelf life.
Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because expired and in-date products may show breakthrough growth of vancomycin-susceptible Enterococcus faecalis near the end of shelf life.