OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1
FDA device recall Z-1595-05 · posted 2005-10-01 · Terminated
Recall details
- Recalling firm
- Oasis Medical Inc
- 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
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KYG
- Quantity affected
- 9,859 cannulas for all codes
- Distribution
- Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
- Date initiated
- 2005-08-24
- Date posted
- 2005-10-01
- Date terminated
- 2014-03-24
- Location
- Glendora, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.