FDAClass IIDecember 30, 2020

ScopeValet Guardian Disposable Endoscope Valves Set recall

ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

Why was ScopeValet Guardian Disposable Endoscope Valves Set 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: 19122419 Unit UDI: 0810929043732 Box UDI: 10810929043739 Carton Box UDI: 20810929041640

Product
ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
Recalling firm
GA HEALTH COMPANY LIMITED
Quantity
10,000 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