FDA-Device2019-02-13Class I
Portex Unit Dose 15 ml Normal Saline ¿
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
357,552
Manufactured in
330 Corporate Woods Pkwy, Vernon Hills, IL, United States
Products
Portex Unit Dose 15 ml Normal Saline ¿
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0720-2019Don't want to check this manually?
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