Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Opht
FDA device recall Z-1224-06 · posted 2006-08-02 · Terminated
Recall details
- Recalling firm
- Medisurg Research & Management Corp
- Reason for recall
- No documentation to support shelf life/sterility
- Action taken
- On 4/28/06, the recalling firm faxed a notification to the customers informing them not to use the product during surgery and to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- NCR
- Quantity affected
- 960 tips
- Distribution
- Nationwide, including CA, CT, FL, GA, MA, NC, NY, OH, OR, PA, TX, and WI.
- Date initiated
- 2006-04-28
- Date posted
- 2006-08-02
- Date terminated
- 2006-09-08
- Location
- Norristown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE FUGO BLADE (K001498) | Medisurg , Ltd. | 2000-08-10 |