PlainRecordsFDA · Medical device recall
Premier Edge MVR 19g Microsurgical Knife… and 3 more products
- Date posted by the FDA
- July 4, 2007
- Status
- Terminated
- Filed by
- Oasis Medical Inc
- Reason
- 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 pattern
- Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.
4 products in this recall
Premier Edge MVR 19g Microsurgical Knife…
- Product
- Premier Edge MVR 19g Microsurgical Knife, Item PE-3519
- Codes and lots
- Lot #'s DK0107W, DK1106G, DK1106R
- Recall started
- June 8, 2007
- Device type
- Knife, Ophthalmic
- Root cause (FDA)
- Device Design
- What the company told customers
- 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."
- Recall number
- Z-0995-2007
Premier Edge MVR 20g Microsurgical Knife…
- Product
- Premier Edge MVR 20g Microsurgical Knife, Item PE-3520
- Codes and lots
- Lot #'s DK0107AJ, DK0107X, DK0307P
- Recall started
- June 8, 2007
- Device type
- Knife, Ophthalmic
- Root cause (FDA)
- Device Design
- What the company told customers
- 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."
- Recall number
- Z-0996-2007
Premier Edge MVR 20g Microsurgical Knife…
- Product
- Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A
- Codes and lots
- Lot #'s DK0107Y, DK0307D, DK0307Q, DK1206M
- Recall started
- June 8, 2007
- Device type
- Knife, Ophthalmic
- Root cause (FDA)
- Device Design
- What the company told customers
- 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."
- Recall number
- Z-0997-2007
Eyemaxx MVR 20g Microsurgical Knife…
- Product
- Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020
- Codes and lots
- Lot #DK1106O
- Recall started
- June 8, 2007
- Device type
- Knife, Ophthalmic
- Root cause (FDA)
- Device Design
- What the company told customers
- 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."
- Recall number
- Z-0998-2007
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0995-2007, Z-0996-2007, Z-0997-2007, Z-0998-2007. The agency record governs; check it and the company before acting.