Z-0713-2019 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2019
- Initiation Date
- September 5, 2017
- Termination Date
- April 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,828
Product Description
Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
Reason for Recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Distribution Pattern
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.
Code Information
Model # 1565 Lot Number: ¿Y371