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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description 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.
Recall Number Z-1600-05
Classification Class II
Code Info Product Specification MK-036V Lot D0305Y
Product Distributed Qty 9,859 cannulas for all codes
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.

Event Detail

Event Id 33431
Product Type Devices
Status Terminated
Recalling Firm Oasis Medical Inc
City Glendora
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2005-08-24
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland