Device product
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
Z-0648-2021
Product summary
- Event
- Event 86763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100,000 units
- Official record key
device-enforcement:Z-0648-2021
Official wording
Reason: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information: Lot Numbers: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384
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