Z-0644-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 3, 2020
- Termination Date
- September 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93,700 units
Product Description
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
Reason for Recall
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Distribution Pattern
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Code Information
Lot Numbers: 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806 Unit UDI: 04897106950263 Box UDI: 14897106950260 Cartoon Box UDI: 24897106950267