Class 2 Device Recall BD Microkeratome K3000 and K4000

• Date Initiated by Firm: August 09, 2007
• Date Posted: October 23, 2007
• Recall Status: Terminated 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: 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