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Recall Observatory FDA recall evidence

Device product

Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

Z-0644-2021

November 03, 2020

Class II

Product summary

Firm
GA HEALTH COMPANY LIMITED
Event
Event 86763
Status
Terminated
Classification
Class II
Quantity
93,700 units
Official record key
device-enforcement:Z-0644-2021

Official wording

Reason: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Code information: Lot Numbers: 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806 Unit UDI: 04897106950263 Box UDI: 14897106950260 Cartoon Box UDI: 24897106950267

Distribution pattern: US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure