Device product
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Z-0102-2019
Product summary
- Event
- Event 81098
- Status
- Terminated
- Classification
- Class II
- Quantity
- 106
- Official record key
device-enforcement:Z-0102-2019
Official wording
Reason: The catheter failed the endotoxin testing.
Code information: UDI: 00816203022059, lot N18687-1
Distribution pattern: US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand
Derived failure modes
-
Unknown
The catheter failed the endotoxin testing.