FDA (Devices) recall action 80086
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.
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
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.
Datascope is recalling 19 cardiopulmonary bypass tubing kits due to a potential cuvette failure that causes monitor error messages.
Datascope is recalling 194 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that triggers a monitor error.
Datascope Corporation is recalling 19 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that causes monitor errors.