FDA-Device2019-02-13Class I
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
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
106,000
Manufactured in
330 Corporate Woods Pkwy, Vernon Hills, IL, United States
Products
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0721-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief