Z-0998-2007
Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020
Oasis Medical, Inc. / initiated 2007-06-08 / Terminated / root cause: design
Oasis Medical Inc began a recall of Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020 on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0998-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Oasis Medical, Inc.
- Product
- Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020
- Product code
- HNN Knife, Ophthalmic
- 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.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- 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."
- Distribution
- Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.
- Product codes and lots
- Lot #DK1106O
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