Home / Recalls / Medical Devices
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Portex Unit Dose 15 ml Normal Saline ¿
Recalled February 13, 2019 · FDA recall Z-0720-2019 · Medex Cardio-Pulmonary Inc.,
Hazard
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. · FDA Class I
Units
357,552
Sold at
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.
Description
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Product
Portex Unit Dose 15 ml Normal Saline ¿
Manufacturer(s)
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →