Date Initiated by Firm | September 20, 2007 |
Date Posted | October 31, 2007 |
Recall Status1 |
Terminated 3 on February 15, 2008 |
Recall Number | Z-0108-2008 |
Recall Event ID |
44929 |
510(K)Number | K903529 |
Product Classification |
Single Use Mechanical Lithotriptor - Product Code LQC
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Product | Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc. |
Code Information |
Model number BML-201Q: Lot numbers 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 | 37 units |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LQC
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