Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/
Recalled Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Hazard / Issue
Devices which did not undergo thermoforming could deform and lose performance.
Issued by
FDA
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