Olympus Corporation of the Americas: Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be

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: 12641 units (8789 US, 3852 OUS) Lot/code info: Model/Catalog Number: KD-VC431Q-0720; Material REF: (1) N5391530, (2) N5391510, (3) N5777830; UDI-DI: (1) 04953170466427, (2) 04953170466427, (3) 04953170466427; All Lots with a valid expiration date

UPC codes

04953170466427

Source

Official record: FDA (Device enforcement) ↗

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