BD K-3000 Microkeratome Blade REF 378607
FDA device recall Z-0634-03 · posted 2003-03-12 · Terminated
Recall details
- Recalling firm
- BD Opthalmic Systems
- Reason for recall
- Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.
- Action taken
- BD Ophthalmic notified customers by telephone and email on 1/ 24/03. Users are requested to destroy blades and Certify destruction by returning reply form.
- Root cause
- Other
- Status
- Terminated
- Product code
- HMY
- Quantity affected
- 1539 Blades
- Distribution
- Nationwide
- Date initiated
- 2003-01-24
- Date posted
- 2003-03-12
- Date terminated
- 2003-04-28
- 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-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (K022637) | Becton, Dickinson & CO | 2002-10-16 |