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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, 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).
Recall Number Z-1595-05
Classification Class II
Code Info 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
Product Distributed Qty 9,859 cannulas for all codes
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

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