Device product
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Z-2589-2023
Product summary
- Event
- Event 92796
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 218 units
- Official record key
device-enforcement:Z-2589-2023
Official wording
Reason: Flexible intubation endoscopes sterility assurance can not be confirmed.
Code information: UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
Distribution pattern: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.
Derived failure modes
-
Sterility assurance
sterility assurance can not be confirmed