Class 2 Device Recall PremierEdge MICROSURGICAL KNIFE

• Date Initiated by Firm: July 18, 2007
• Date Posted: January 12, 2008
• Recall Status: Terminated on September 25, 2009
• Recall Number: Z-0486-2008
• Recall Event ID: 45870
• Product Classification: Ophthalmic Knife - Product Code HNN
• Product: PremierEdge MICROSURGICAL KNIFE,1.2mm, Sideport Knife, REF/Item Code: PE 3012, Oasis, Glendora, CA 91741
• Code Information: Lot No.: DK0407A, and DK0407B
• Recalling Firm/ Manufacturer: Oasis Medical Inc; 514 S Vermont Ave Bldg 510-528; Glendora CA 91741-6205
• For Additional Information Contact: Robyn Scopis; 800-528-9786
• Manufacturer Reason for Recall: 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
• FDA Determined 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 product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS Medical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.