Device product
Flamingo Funnel Large, Model Number SQ20012-03
Z-1926-2026
Product summary
- Event
- Event 98574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2505 units total
- Official record key
device-enforcement:Z-1926-2026
Official wording
Reason: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Code information: UDI-DI: 408882777851966; Lot 8264501
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.
Derived failure modes
-
Manufacturing or process control
manufacturing nonconformance