FDA (Devices) recall action 71674
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.
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
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.
Cadence Inc. is recalling 766 non-sterile Perfectum Tuberculin Glass Syringes because graduation marks are not centered with numeric position marks.
Cadence Inc. is recalling 1,665 non-sterile Micro-Mate Tuberculin Glass Syringes because graduation marks are not centered with numeric position marks.