Karl Storz recalls endoscopy fiber scopes model 11005BC1 due to incorrect sterilization instructions in manual, risking unsterile reprocessing. Affected units may need to check manual for proper sterilization steps.
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.
Karl Storz is recalling endoscopy fiber scopes model 11005BC1 because the instruction manual has incorrect sterilization steps for the STERIS System 1E. This could mean the scopes aren't properly sterilized when reprocessed, potentially causing infections.
The instruction manual contains incorrect information about the Quick Connector Kits (QCK) for the STERIS System 1E sterilization method. If users follow these incorrect steps, the scope may not be properly sterilized when reprocessed, increasing infection risk.
Healthcare professionals using the Karl Storz endoscopy fiber scope model 11005BC1 are most at risk if they follow the incorrect sterilization instructions in the manual.
Check for the model number 11005BC1 on the scope. This recall applies to all lots of this model.
Check the manual for correct sterilization steps for the STERIS System 1E to ensure proper scope reprocessing.
The instruction manual has incorrect information about the Quick Connector Kits for the STERIS System 1E sterilization method, which could lead to unsterile reprocessing.
This recall applies to all Karl Storz endoscopy fiber scopes with model number 11005BC1.
Review the sterilization instructions in the manual to ensure proper reprocessing using the correct method for the STERIS System 1E.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1532-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1532-2020 from Karl Storz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
