Device product
Portex Unit Dose 15 ml Normal Saline ¿
Z-0720-2019
Product summary
- Event
- Event 81021
- Status
- Terminated
- Classification
- Class I
- Quantity
- 357,552
- Official record key
device-enforcement:Z-0720-2019
Official wording
Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Code information: Model # R0159 Lot Numbers: ¿A661, B067, A526, A536, A569, and B201
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.
Derived failure modes
-
Sterility assurance
Lack of sterility