Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿

Recall date

September 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0713-2019

FDA classification

Class I

Brand / firm

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Sold / distributed

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, Ger…

Why it was recalled

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿