Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Reported: February 13, 2019 Initiated: September 5, 2017 #Z-0721-2019
Product Description
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Reason for Recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Details
- Recalling Firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Units Affected
- 106,000
- Distribution
- 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.
- Location
- Vernon Hills, IL
Frequently Asked Questions
What product was recalled? ▼
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿. Recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company. Units affected: 106,000.
Why was this product recalled? ▼
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2019. Severity: Critical. Recall number: Z-0721-2019.
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