| 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-1599-05 |
Recall Event ID |
33431 |
Product Classification |
Device, Irrigation, Ocular Surgery - Product Code KYG
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Product | OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is
placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped. |
Code Information |
Product Specification 8065403604 Lot D0304S Lot D0405A Y Lot D05058H |
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. 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 |
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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