Recall Z-0503-2008 ยท HNN Knife, Ophthalmic
Oasis Medical Inc
PremierEdge MICROSURGICAL KNIFE ,4.0mm Implant Knife, Item Code/REF: PE 3440; OASIS Glendora, CA 91741
| Date | Jan 12, 2008 (initiated Jul 18, 2007) |
| Status | Terminated |
| Reason | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Root cause | Device Design |
| Action | A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine prod |
| Quantity | 28,319 individual knives (Z-0485-0516-2008) |
| Distribution | Worldwide: USA, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Norway, South Africa, Saudi Arabia, Slovakia, Spain, Sweden, Switzwerland, Turkey, United Kingdom, Ecuador, Finland, France, Germany, Greece, Italy, Denmark, Columbia, Chile, Brazil, Belgium, and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.