Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wi
Recalled Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A 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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