FDAClass IIDecember 30, 2020

Andorate Disposable Endoscope Valves Set-Contains recall

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

Why was Andorate Disposable Endoscope Valves Set-Contains 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: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503 Unit UDI: 04897106950225 Box UDI: 14897106950222 Cartoon Box UDI: 24897106950229

Product
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
Recalling firm
GA HEALTH COMPANY LIMITED
Quantity
6,470 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