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.
- Company
- Oasis Medical, Inc.
- Recall Initiated
- August 24, 2005
- Posted
- October 1, 2005
- Terminated
- March 24, 2014
- Recall Number
- Z-1600-05
- 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 MK-036V Lot D0305Y
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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