Home / Recalls / GA HEALTH COMPANY LIMITED / Z-0639-2021

Z-0639-2021 Class II Terminated

Recalled by GA HEALTH COMPANY LIMITED — Shatin N.T., N/A

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
12,800 units

Product Description

STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

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: 19121831, 20032007 Unit UDI: 04897106951093 Box UDI: 14897106951090 Carton Box UDI: 24897106951097

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  • Z-0647-2021 Class II — Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Va (November 3, 2020)
  • Z-0642-2021 Class II — STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGIC (November 3, 2020)
  • Z-0645-2021 Class II — Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning A (November 3, 2020)
  • Z-0643-2021 Class II — Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve (November 3, 2020)
  • Z-0646-2021 Class II — Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy V (November 3, 2020)
  • Z-0640-2021 Class II — STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-va (November 3, 2020)
  • Z-0641-2021 Class II — STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water (November 3, 2020)
  • Z-0644-2021 Class II — Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Val (November 3, 2020)