Recall Z-0066-2008 ยท HMY Keratome, Battery-Powered
Becton Dickinson and Company
BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)
| Date | Oct 23, 2007 (initiated Aug 9, 2007) |
| Status | Terminated |
| Reason | Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 256 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023092 | BD K-4000 MICROKERATOME SYSTEM Becton, Dickinson & CO, Oct 18, 2002 |