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Class 2 Device Recall Laser Surgical Fiber |
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Date Initiated by Firm |
December 18, 2007 |
Date Posted |
April 09, 2008 |
Recall Status1 |
Terminated 3 on April 09, 2008 |
Recall Number |
Z-0585-2008 |
Recall Event ID |
46251 |
510(K)Number |
K011703
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Product Classification |
Surgical Powered Laser Instrument - Product Code GEX
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Product |
Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL. |
Code Information |
Lot number 61280807. |
Recalling Firm/ Manufacturer |
Lumenis, Inc. 3959 W 1820 S Salt Lake City UT 84104-4951
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For Additional Information Contact |
801-656-2300
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Manufacturer Reason for Recall |
Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
The firm notified Consignee by certified letter on 12/18/2007, and asked that all affected products be return. Any questions concerning this recall can be addressed by contacting the Manager, Regulatory Compliance, at 1-877-586-3646 ext. 3355. |
Quantity in Commerce |
59 units. |
Distribution |
MA |
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 = GEX and Original Applicant = LUMENIS
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