Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Karl Storz Endoscopy
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269Model 2273282Model 2276217Model 2276216Model 2264656Model 2275787Model 2279756Model 2280154Model 2280379Model 2275789Model 2283453Model 2277877Model 2280204Model 2273324Model 2275986Model 2283483Model 2229591Model 2273599Model 2215800Model 2274197Model 2280156Model 2275483Model 2083136Model 2275790Model 2275482UPC 04048551226087Would you have heard about this one?
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