| Class 2 Device Recall OASIS Medical Vidaurri LASIK Flap Irrigator | |
Date Initiated by Firm | August 24, 2005 |
Date Posted | 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
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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
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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 |
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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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