FDA (Devices) recall action 68512
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.
Report of the product penetrating the sterile barrier; this could render the product unsterile.
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.
Vascular Technology, Inc. is recalling 25 VTI Bayonet Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.
Vascular Technology, Inc. is recalling 147 Mizuho Doppler Probes because the sterile barrier was penetrated, potentially rendering the devices unsterile.
Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.
Vascular Technology, Inc. is recalling 164 Mizuho disposable Doppler probes because the sterile barrier was penetrated, potentially rendering the product unsterile.