Olympus Corporation of the Americas: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been desig

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: 65117 units (9707 US, 55410 OUS) Lot/code info: Model/Catalog Number: KD-V411M-0720; Material REF: (1) N1089610, (2) N5411330; UDI-DI: (1) 04953170184017, (2) 04953170380570; All Lots with a valid expiration date

UPC codes

04953170184017, 04953170380570

Source

Official record: FDA (Device enforcement) ↗

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