FDAFDA · Food and drugs·Recall number Z-0721-2019
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Published February 13, 2019 · Recall initiated: September 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Distributor
- 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.
- Lot
- Model # UD9005 Lot Number: ¿B515
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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