Olympus Corporation of the Americas: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instr

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: 1918 units (413 US, 1505 OUS) Lot/code info: Model/Catalog Number: KD-VC412Q-0215; Material REF: (1) N5391410, (2) N5391430, (3) N5777730; UDI-DI: (1) 04953170371158, (2) 04953170371158, (3) 04953170371158; All Lots with a valid expiration date

UPC codes

04953170371158

Source

Official record: FDA (Device enforcement) ↗

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