BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)
FDA device recall Z-0066-2008 · posted 2007-10-23 · Terminated
Recall details
- Recalling firm
- Becton Dickinson and Company
- Reason for recall
- Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea
- Action taken
- BD Medical notified customers by Advisory Letter dated 8/09/07, advising users to return heads and bearing cartridges for replacement of the o-ring.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HMY
- Quantity affected
- 256 units
- Distribution
- Worldwide
- Date initiated
- 2007-08-09
- Date posted
- 2007-10-23
- Date terminated
- 2012-02-29
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD K-4000 MICROKERATOME SYSTEM (K023092) | Becton, Dickinson & CO | 2002-10-18 |