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.
- Company
- Oasis Medical, Inc.
- Recall Initiated
- August 24, 2005
- Posted
- October 1, 2005
- Terminated
- March 24, 2014
- Recall Number
- Z-1599-05
- Quantity
- 9,859 cannulas for all codes
- Firm Location
- Glendora, CA
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
Distribution
Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
Lot / Code Info
Product Specification 8065403604 Lot D0304S Lot D0405A Y Lot D05058H
Root Cause
Other
Action Taken
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.
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