OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The
FDA device recall Z-1599-05 · 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. 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
- 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
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