Class 3 Device Recall Olympus Single Use Mechanical Lithotriptor

• Date Initiated by Firm: September 20, 2007
• Date Posted: October 31, 2007
• Recall Status: Terminated on February 15, 2008
• Recall Number: Z-0106-2008
• Recall Event ID: 44929
• 510(K)Number: K903529
• Product Classification: Single Use Mechanical Lithotriptor - Product Code LQC
• Product: Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Olympus America, Inc.
• Code Information: Model number BML-V232QR-30: Lot numbers 75K, 76K, and 77K.
• Recalling Firm/ Manufacturer: Olympus America Inc.; 3500 Corporate Pkwy.; P.O. Box 610; Center Valley PA 18034-0610
• For Additional Information Contact: Laura Storms-Tyler; 484-896-5688
• Manufacturer Reason for Recall: Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
• FDA Determined Cause: Process control
• Action: The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.
• Quantity in Commerce: 201 units
• Distribution: Nationwide
• 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.

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