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U.S. Department of Health and Human Services

Class 2 Device Recall Becton Dickinson Microkeratome Blade

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  Class 2 Device Recall Becton Dickinson Microkeratome Blade see related information
Date Initiated by Firm January 24, 2003
Date Posted March 12, 2003
Recall Status1 Terminated 3 on April 28, 2003
Recall Number Z-0634-03
Recall Event ID 25652
510(K)Number K022637  
Product Classification Keratome, Battery-Powered - Product Code HMY
Product BD K-3000 Microkeratome Blade
REF 378607
Code Information Manufacturing Lot Numbers: 959, 962, 964, 965, and 966
Recalling Firm/
Manufacturer		 BD Opthalmic Systems
411 Waverly Oaks Road
Waltham MA 02452
For Additional Information Contact David Cromwick
781-906-7916
Manufacturer Reason
for Recall		 Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 1539 Blades
Distribution Nationwide
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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