FDA (Devices) recall action 80460
The FDA (Devices) publishes a recall like this one as 20 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 20 pages.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
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.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the luer and manifold.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold.
ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
ICU Medical is expanding a recall of 150 pouches of smallbore I.V. administration sets with NanoClave manifolds due to potential leaks or component separation.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
ICU Medical is expanding a recall for I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold.
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.