medical Class II Updated 2020-04-01

Karl Storz Endoscopy recalls Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pedi

Recalled Product

Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

Hazard / Issue

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.

Issued by

FDA

Affected States: 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
Lot/Code Info: All Lots
View official government recall

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