Device product
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
Z-0716-2019
Product summary
- Event
- Event 81021
- Status
- Terminated
- Classification
- Class I
- Quantity
- 16,104 Japan only
- Official record key
device-enforcement:Z-0716-2019
Official wording
Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Code information: Model # 0552IMJ Lot Numbers: ¿Z588 and Z597
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