Karl Storz Endoscopy: Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123

Hazard

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Details from the source

Reason for recall: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam. Quantity: 5 units Lot/code info: All Lots/UDI: (01)04048551234099

UPC codes

04048551234099

Source

Official record: FDA (Device enforcement) ↗

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