Device product
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71
Z-0646-2021
Product summary
- Event
- Event 86763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,000 units
- Official record key
device-enforcement:Z-0646-2021
Official wording
Reason: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information: Lot Numbers: 20B10A Unit UDI: 0816734021330 Box UDI: 10816734021337 Cartoon Box UDI: 20816734021334
Distribution pattern: US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Derived failure modes
-
Unknown
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure