Olympus Corporation of the Americas: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an

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: 1025 units (OUS only) Lot/code info: Model/Catalog Number: KD-V411M-3025; Material REF: N1090210; UDI-DI: N/A; 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.