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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 Posted October 01, 2005
Recall Status1 Terminated 3 on March 24, 2014
Recall Number Z-1600-05
Recall Event ID 33431
Product Classification unknown device name - Product Code KYG
Product OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification MK-036V, LASIK Flap Irrigator (Vidaurri)
The MK-03V cannula is placed into a vacuum formed plastic tray and a blank Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and placed into a polybag. The polybag is sealed and labeled. Typically there are 100 pouches per polybag.
Code Information Product Specification MK-036V Lot D0305Y
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. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is 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
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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