PremierEdge MICROSURGICAL KNIFE, 3.2mm Slit Knife; Item Code/REF: PE 3832; OASIS Glendora, CA 91741
- Company
- Oasis Medical, Inc.
- Recall Initiated
- July 18, 2007
- Posted
- January 12, 2008
- Terminated
- September 25, 2009
- Recall Number
- Z-0512-2008
- Quantity
- 28,319 individual knives (Z-0485-0516-2008)
- Firm Location
- Glendora, CA
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
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
Lot / Code Info
Lot No: DK1106Q
Root Cause
Device Design
Action Taken
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.