Karl Storz Endoscopy: Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

Hazard

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

Details from the source

Reason for recall: Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility. Distribution: US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT. Quantity: 45 Lot/code info: Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785. 26153EAU/1 seals with expiration date: January 23, 2023.

UPC codes

04048551226087

Source

Official record: FDA (Device enforcement) ↗

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