Device product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Z-1918-2023
Product summary
- Event
- Event 92301
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1918-2023
Official wording
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Code information: Lot # I2578012; UDI-DI: 00884450488539
Distribution pattern: Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.
Derived failure modes
-
Unknown
There is a potential that valve assemblies will not open. preventing fluid from draining.