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Terminated

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).

FDA Recall Z-1595-05 · Posted 2005-10-01

Recalling FirmOasis Medical Inc
Recall StatusTerminated
Product CodeKYG
Date Initiated2005-08-24
Date Terminated2014-03-24
Product Quantity9,859 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

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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