FDA (Devices) recall action 84896
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Karl Storz is recalling 42 flexible neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
Karl Storz is recalling 21 RHINO-LARYNGO-BRONCHO FIBERSCOPE units because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.