FDA (Devices) recall action 81021
The FDA (Devices) publishes a recall like this one as 13 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 13 pages.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
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.
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.
Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.
Smiths Medical is recalling Intermed 550 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Smiths Medical is recalling Portex Unit Dose 15 ml Normal Saline products because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Smiths Medical is recalling 106,000 units of Portex 5ml Normal Saline due to leaking containers that may compromise sterility and expose patients to infectious agents.
Smiths Medical is recalling Intermed 350 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.
Medex Cardio-Pulmonary Inc. is recalling 235,560 units of Medline Prefilled 350 ml Sterile Solution because leaking containers may compromise sterility and expose patients to infectious agents.
Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose patients to infectious agents.
Smiths Medical is recalling Portex 500 ml Sterile Water USP Pour Bottles because leaking containers may compromise sterility and expose users to infectious agents.
Smiths Medical is recalling Medline sterile water humidifiers because leaking containers may expose patients to infectious agents.
Smiths Medical is recalling Portex Unit Dose 5 ml Normal Saline because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.