Device product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Z-1911-2023
Product summary
- Event
- Event 92301
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 670 units
- Official record key
device-enforcement:Z-1911-2023
Official wording
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Code information: Lot # I2533611, I2546597, I2559292, I2548163 & I2578001; UDI-DI: 00884450394908
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.