Skip to content
Recall Observatory FDA recall evidence

Device product

Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

Z-0643-2021

November 03, 2020

Class II

Product summary

Firm
GA HEALTH COMPANY LIMITED
Event
Event 86763
Status
Terminated
Classification
Class II
Quantity
6,470 units
Official record key
device-enforcement:Z-0643-2021

Official wording

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

Code information: Lot Numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503 Unit UDI: 04897106950225 Box UDI: 14897106950222 Cartoon Box UDI: 24897106950229

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