Class 2 Device Recall Intubation Fiberscope

• Date Initiated by Firm: April 24, 2019
• Create Date: August 31, 2019
• Recall Status: Terminated on December 04, 2020
• Recall Number: Z-2447-2019
• Recall Event ID: 83419
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: Flexible Intubation Fiberscope, Model # 11301AB1
• Code Information: Lot numbers: 2183827, 2195794, 2215741, 2229258, 2235373, 2248169, 2193769
• Recalling Firm/ Manufacturer: Karl Storz Endoscopy; 2151 E Grand Ave; El Segundo CA 90245-5017
• For Additional Information Contact: Emily Cuadros; 424-218-8289
• Manufacturer Reason for Recall: The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
• FDA Determined Cause: Process control
• Action: The firm mailed a "safety alert" on April 24, 2019 via FedEx. 2nd day delivery. The safety alert advised customers to do the following: 1. If you use the following automated processes, the high level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed: Reprocessing Method Impact, Medivators AER * Patient Safety may be Compromised, STERIS System 1E (SS1E)** Patient Safety may be Compromised The above connectors can only connect onto one port, therefore leaving the other port open. Depending on the reprocessing system, the cycle could result in an error or in successful completion of the cycle. " If an error code is displayed, the user would know the cycle is not complete and the scope has not been successfully reprocessed. " If the cycle is completed without an error code, the high-level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed. Improper reprocessing may result in incomplete decontamination, which may result in a cross-contamination patient infection. If you use Medivators AER or STERIS SS1E to reprocess this scope, please be aware of the possible risks and take the necessary actions to address any patient safety concerns. 2. Please complete the attached Action Requested form and follow the instructions outlined on the form. 3. you have any questions please contact the following person: This Recall Action, Emily Cuadros, Complaint Handling , 424-218-8289 Reprocessing, Shaun McGinley, Director of Reprocessing, 424-218-8247 Patient Safety, Dr. Dennis Fowler, Chief Medical Officer, 424-218-8603
• Quantity in Commerce: 14 scopes
• Distribution: US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.