FDA (Devices) recall action 85776
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Lack of assurance of sterility
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.
Prodimed is recalling Combicath Paediatric catheters due to a lack of assurance of sterility. The recall covers 2,580 units distributed nationwide.
Prodimed Plastimed Division is recalling 7,220 Combicath catheters for mini bronchoalveolar lavage due to a lack of assurance of sterility.
Prodimed Plastimed Division is recalling Combicath catheters for mini bronchoalveolar lavage because of a lack of assurance of sterility.
Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.
Prodimed is recalling 1,460 Combicath catheters nationwide because the company cannot assure the products are sterile.
Prodimed Plastimed Division is recalling 300 Combicath catheters nationwide due to a lack of assurance of sterility.