Recall Z-0711-2019— Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Class I · Terminated
Class I FDA medical device recall by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, initiated 2017-09-05, terminated 2024-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿. Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents..
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-09-05
- Terminated
- 2024-04-16
- Firm location
- Vernon Hills, IL, United States
Product description
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
Reason for recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Data sourced from openFDA. This site is unofficial and independent of the FDA.