Karl Storz Flexible Hystero-Fiberscope Kits recalled for expired sterile seals
Karl Storz Flexible Hystero-Fiberscope Kits with certain serial numbers contain expired single-use endoscopic seals that may not maintain sterility during gynecological procedures. The affected seals expired in January 2023 and were distributed across 15 U.S. states.
From the FDA notice · Read the official notice ↗
What to do
- Check if your kit's serial number matches the affected list (45 kits total).
- Do not use affected kits in clinical procedures.
- Contact Karl Storz or your distributor for instructions on replacement or return.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 45
- Illnesses reported
- None reported
- Manufactured in
- 2151 E Grand Ave, N/A, El Segundo, CA, United States
- Classification
- Class II
- Recall number
- Z-2794-2026
In the FDA's words
- Description
- Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1. 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. 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. Distribution: US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT. Affected quantity: 45
- 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.
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