Home / Recalls / GA HEALTH COMPANY LIMITED / Z-0648-2021

Z-0648-2021 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
100,000 units

Product Description

ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

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: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384

Other recalls by GA HEALTH COMPANY LIMITED

  • Z-0649-2021 Class II — ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy (November 3, 2020)
  • Z-0647-2021 Class II — Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Va (November 3, 2020)
  • Z-0639-2021 Class II — STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Wat (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)