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Recall Observatory FDA recall evidence

Device product

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72

Z-0647-2021

November 03, 2020

Class II

Product summary

Firm
GA HEALTH COMPANY LIMITED
Event
Event 86763
Status
Terminated
Classification
Class II
Quantity
20,000 units
Official record key
device-enforcement:Z-0647-2021

Official wording

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

Code information: Lot Numbers: 20B10B, 20G10A Unit UDI: 0816734021347 Box UDI: 10816734021344 Cartoon Box UDI: 20816734021341

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