Date Initiated by Firm | August 09, 2007 |
Date Posted | October 23, 2007 |
Recall Status1 |
Terminated 3 on February 29, 2012 |
Recall Number | Z-0066-2008 |
Recall Event ID |
38739 |
510(K)Number | K023092 |
Product Classification |
Microkeratome - Product Code HMY
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Product | BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD) |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Becton Dickinson and Company 411 Waverley Oaks Rd Ste 2229 Waltham MA 02452-8448
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For Additional Information Contact | David Cromwick 781-906-7916 |
Manufacturer Reason for Recall | Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea |
FDA Determined Cause 2 | 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 in Commerce | 256 units |
Distribution | Worldwide |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HMY
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