Class 2 Device Recall Tracheal Intubation Fiberscope

• Date Initiated by Firm: July 27, 2023
• Date Posted: August 31, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2504-2023
• Recall Event ID: 92779
• 510(K)Number: K981543
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
• Code Information: UDI-DI: 04953170136856, 04953170340192, 04953170061998, 04953170340215, 04953170317576, & 04953170136825; All Serial Numbers.
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: Cynthia Ow; 647-999-3203
• Manufacturer Reason for Recall: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
• FDA Determined Cause: Labeling Change Control
• Action: Consignees were mailed an Urgent Medical Device Correction notification dated 7/27/2023 via UPS. The notification asks that consignees inspect their inventory for recalled devices and check clinical areas to see if any remain in use. Consignees are to ensure that all personnel, including clinical staff, are completely knowledgeable of this recall notification and addendum, which instructs users to slide the endotracheal tube along the entire length of the tracheal intubation scope insertion section to confirm compatibility before using on a patient. Consignees are asked to complete and return the provided response form to Sedgwick via email at Olympus7498@sedgwick.com or by fax at 866-552-4917. Any questions about the acknowledgement form may be directed by phone to 866-737-4762. If product has been further distributed, please forward the notification to those secondary consignees and maintain records of your documentation process. Consignees are to report any complaints to Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) and FDA Medwatch. Any further questions are to be directed to Tara Safi by email at Tara.Safi@Olympus.com.
• Quantity in Commerce: 10801 units
• Distribution: US Nationwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = EOQ