FDA (Devices) recall action 81952
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.
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
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 Phoenix AP AST Indicator Bags because certain lots cause increased test aborts. The products were distributed to 40 US states and 33 foreign countries.
Becton Dickinson is recalling Phoenix AST Indicator lots because panels show increased test aborts. The recall covers 62,880 units distributed in the US and 33 foreign countries.
Becton Dickinson is recalling Phoenix AST-s Indicator lots because they cause increased test aborts. The products were distributed to 41 US states and 33 foreign countries.