Karl Storz Rhino-laryngo-broncho Fiberscope recall: Sterility Concern
Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
Why was Karl Storz Rhino-laryngo-broncho Fiberscope recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots
- Product
- Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 21 scopes
- Distribution
- US: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV, OUS: Canda
- Recall date
- April 1, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)