Date Initiated by Firm |
September 20, 2007 |
Date Posted |
October 31, 2007 |
Recall Status1 |
Terminated 3 on February 15, 2008 |
Recall Number |
Z-0107-2008 |
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-V242QR-30, Olympus America, Inc. |
Code Information |
Model number BML-V242QR-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 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 |
153 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.
|