FDAClass IIDecember 30, 2020

Andorate Disposable Endoscope Valves Set-5-piece Valve recall

Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

Why was Andorate Disposable Endoscope Valves Set-5-piece Valve recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 20031002 Unit UDI: 04897106952571 Box UDI: 14897106952578 Cartoon Box UDI: 24897106952575

Product
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
Recalling firm
GA HEALTH COMPANY LIMITED
Quantity
50 units
Distribution
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Recall date
December 30, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls