FDA (Devices) recall action 78391
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
The agency’s own wording, quoted from the enforcement report.
Halyard Health is recalling specific lots of 15ml saline vials used in the Turbo-Cleaning Closed Suction System because they may leak, potentially exposing contents to infectious agents.
Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.
Halyard Health is recalling specific lots of Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.
Halyard Health is recalling NOVAPLUS Endotracheal WET PAK Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.
Halyard Health is recalling specific lots of Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.
Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing the contents to infectious agents.
Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.
Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing contents to infectious agents.
Halyard Health is recalling specific lots of Closed Suction Systems because the saline vials may leak, potentially exposing contents to infectious agents.