Olympus Corporation of the Americas: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-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: 7689 units (7501 US, 188 OUS) Lot/code info: Model/Catalog Number: KD-431Q-0720; Material REF: (1) 5859230, (2) N6221831, (3) N6221840; UDI-DI: (1) 04953170042362, (2) 04953170463778, (3) 04953170466564; All Lots with a valid expiration date

UPC codes

04953170042362, 04953170463778, 04953170466564

Source

Official record: FDA (Device enforcement) ↗

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