FDA (Devices) recall action 77406
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.
Lack of sterility assurance.
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.
Creganna Medical Devices is recalling 85 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.
Creganna Medical Devices is recalling 100 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.
Creganna Medical Devices is recalling 50 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.
Creganna Medical Devices is recalling 150 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance. The devices were distributed in Massachusetts.