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U.S. Department of Health and Human Services

Class 2 Device Recall Laser Surgical Fiber

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 Class 2 Recall
Laser Surgical Fiber
see related information
Date Posted April 09, 2008
Recall Status1 Terminated on April 09, 2008
Recall Number Z-0585-2008
Recall Event ID 46251
Premarket Notification
510(K) Number
K011703 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
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, Utah 84104-4951
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = LUMENIS
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