FDA (Devices) recall action 84722
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.
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
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.
Teleflex Medical Inc. is recalling 1,764 Pilling Aortic Punch devices because packaging defects may compromise sterility.
Teleflex Medical is recalling 587,066 units of Disposable Aortic Punches because packaging may be compromised, potentially affecting device sterility.