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U.S. Department of Health and Human Services

Class 2 Device Recall MicroVisionMedical MicroScan Lense Disposable Plastic Cap

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  Class 2 Device Recall MicroVisionMedical MicroScan Lense Disposable Plastic Cap see related information
Date Initiated by Firm July 21, 2006
Date Posted August 23, 2006
Recall Status1 Terminated 3 on November 15, 2006
Recall Number Z-1435-06
Recall Event ID 35964
Product Classification Lens - Product Code FSO
Product MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
Code Information Lot number 583546
Recalling Firm/
Manufacturer		 Microvision Medical Holding B.V.
Meibergdreef 45
Amsterdam Netherlands
For Additional Information Contact Richard A. Johnson
215-498-2111
Manufacturer Reason
for Recall		 Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier
FDA Determined
Cause 2		 Other
Action The recalling firm issued a recall letter dated 7/21/06 to their customers informing them of the problem and the need to return the product.
Quantity in Commerce 540 caps
Distribution World wide-The product was shipped to physicians in UT, IA, OR, MA, LA, CA. The product was also shipped to Germany, United Kingdom, and The Netherlands.
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.
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