FDA-Device2019-02-13Class I
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Hazard
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Sold states
Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
Affected count
16,380
Manufactured in
330 Corporate Woods Pkwy, Vernon Hills, IL, United States
Products
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0717-2019Don't want to check this manually?
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