FDA (Devices) recall action 96961
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.
Cather packaging may contain the incorrect French size.
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.
C.R. Bard Inc is recalling BD Heyman Follower Straight Tip catheters because packaging may contain an incorrect French size designation, which could lead to use of the wrong catheter size.
C.R. Bard Inc is recalling certain BD Heyman Follower Coude Tip catheters because the packaging may display the incorrect French size, which could lead to use of the wrong size device.
C.R. Bard Inc is recalling 63 units of the Bard Urologist's Tray due to cather packaging that may contain the incorrect French size, which could affect device use.