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U.S. Department of Health and Human Services

Class 3 Device Recall Olympus Single Use Mechanical Lithotriptor

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  Class 3 Device Recall Olympus Single Use Mechanical Lithotriptor see related information
Date Initiated by Firm September 20, 2007
Date Posted October 31, 2007
Recall Status1 Terminated 3 on February 15, 2008
Recall Number Z-0105-2008
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-26, Olympus America, Inc.
Code Information Model number BML-V232QR-26: 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 2
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 91 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 and Original Applicant = OLYMPUS CORP.
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