Olympus Corporation of the Americas: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with a

Hazard

Devices which did not undergo thermoforming could deform and lose performance.

Details from the source

Reason for recall: Devices which did not undergo thermoforming could deform and lose performance. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD. Quantity: 125 units (7 US, 118 OUS) Lot/code info: Model/Catalog Number: KD-411Q-0720; Material REF: 5858030; UDI-DI: Under Review; All Lots with a valid expiration date

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.