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U.S. Department of Health and Human Services

Class 2 Device Recall BD Microkeratome K3000 and K4000

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  Class 2 Device Recall BD Microkeratome K3000 and K4000 see related information
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
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
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

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.
510(K) Database 510(K)s with Product Code = HMY and Original Applicant = BECTON DICKINSON & CO.
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