FDAClass IIJune 21, 2017

Vue Optic Visualization Source recall

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in…

Why was Vue Optic Visualization Source recalled?

Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

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?

Vue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343 Flexor Vue Deflecting Endoscopic System Catalog Number: FV-090075-150, GPN: G50972 Catalog Number: FV-090045-150, GPN: G34306

Product
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in…
Recalling firm
Cook Inc.
Quantity
1328 units
Distribution
Domestic: FL IN LA MS NC TX Foreign:Argentina, Australia, Brazil, Canada, Czech Republic, Egypt, Estonia, France, Germany, Israel, Italy, Netherlands, Norway, Paraguay, Poland, Portugal, Russian Federation, Spain, Switzerland, Tunisia, Turkey, United Kingdom, VA/DOD:None
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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