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U.S. Department of Health and Human Services

Class 2 Device Recall OASIS Medical Vidaurri LASIK Flap Irrigator

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  Class 2 Device Recall OASIS Medical Vidaurri LASIK Flap Irrigator see related information
Date Initiated by Firm August 24, 2005
Date Posting Updated October 01, 2005
Recall Status1 Terminated 3 on March 24, 2014
Recall Number Z-1595-05
Recall Event ID 33431
Product Classification Device, Irrigation, Ocular Surgery - Product Code KYG
Product OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight .25mm ports (four per tip).
Code Information Product Specification 4036V Lot D1201AD, Lot D0702A Y, Lot D0802J, Lot D09028 Lot D0103V Lot D0303S Lot D1203AH Lot D0104AC Lot D0304AQ Lot D0504AG Lot D0105AV Lot D0205J, Lot D0305AH Lot D03058D Lot D0605AE Lot D0705Y, Lot D0805A8.
Recalling Firm/
Manufacturer
Oasis Medical Inc
512 S Vermont Ave
Glendora CA 91741-6205
For Additional Information Contact Brett Nelson
626-852-5156
Manufacturer Reason
for Recall
"Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators
FDA Determined
Cause 2
Other
Action OASIS Medical shall inform all customers that have received the product via FAX and Certified Mail to cease use immediately and return all unused product to OASIS.
Quantity in Commerce 9,859 cannulas for all codes
Distribution Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
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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