Z-1532-2020 Class II Ongoing
FDA device recall Z-1532-2020 was initiated by Karl Storz Endoscopy on August 27, 2019 and is designated Class II. Reason for recall: 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 informatio… The recall status is ongoing. Affected quantity: 21 scopes.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- August 27, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 scopes
Product Description
Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
Reason for Recall
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.
Distribution Pattern
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
Code Information
All Lots