FDA (Devices) recall action 85751
The FDA (Devices) publishes a recall like this one as 14 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 14 pages.
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
The agency’s own wording, quoted from the enforcement report.
Carefusion 2200 Inc is recalling Thora-Para 8 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T-Centesis 6 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T 8 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion is recalling Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T 5 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T-Centesis PLUS 6 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T-Centesis PLUS 8 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Thora-Para 5 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T-Centesis 6 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Thora-Para 8 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T-Centesis 8 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Carefusion 2200 Inc is recalling Thora-Para 5 Fr Non-Valved Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.