FDA (Devices) recall action 84113
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.
Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.
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 BD Posiflush syringes because a limited number of experimental units were mixed with standard products.
Becton Dickinson is recalling BD Posiflush Pre-Filled Normal Saline Syringes because a limited number of experimental units were mixed with standard stock.