FDA (Devices) recall action 70081
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
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.
Centurion Medical Products is recalling 480 Nerve Block Trays due to a confirmed report of human hair embedded in a stopper.
Centurion Medical Products is recalling 8 pacemaker trays because a customer reported human hair embedded in the stopper of a single unit.
Centurion Medical Products is recalling 760 Diagnostic Imaging Trays due to a confirmed report of human hair embedded in a stopper.
Centurion Medical Products is recalling 42 Chest Tube Tray kits because a single unit was found to contain human hair embedded in the stopper.