Recall Z-1601-05 ยท KYG Device, Irrigation, Ocular Surgery
Oasis Medical Inc
OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri) The -B4036V-NS cannula 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 polybag. The polybag is sealed and labeled. Typically there are 100 trays per polybag.
| Date | Oct 1, 2005 (initiated Aug 24, 2005) |
| Status | Terminated |
| Reason | "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 |
| Root cause | Other |
| 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.