Premier Edge MVR 19g Microsurgical Knife, Item PE-3519
- Company
- Oasis Medical, Inc.
- Recall Initiated
- June 8, 2007
- Posted
- July 4, 2007
- Terminated
- September 25, 2009
- Recall Number
- Z-0995-2007
- Firm Location
- Glendora, CA
Reason for Recall
This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.
Distribution
Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.
Lot / Code Info
Lot #'s DK0107W, DK1106G, DK1106R
Root Cause
Device Design
Action Taken
Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once ofthis product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."