Portex Unit Dose 15 ml Normal Saline
- Recall Initiated
- September 5, 2017
- Posted
- February 4, 2019
- Terminated
- April 16, 2024
- Recall Number
- Z-0720-2019
- Quantity
- 357,552
- Firm Location
- Vernon Hills, IL
Reason for Recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
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.
Lot / Code Info
Model # R0159 Lot Numbers: ¿A661, B067, A526, A536, A569, and B201
Root Cause
Process control
Action Taken
Firm sent recall notification letters to customers on 9/5/2017.
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