Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)

FDA Recall Z-0066-2008 · Posted 2007-10-23

Recalling FirmBecton Dickinson and Company
Recall StatusTerminated
Product CodeHMY
Date Initiated2007-08-09
Date Terminated2012-02-29
Product Quantity256 units

Reason for Recall

Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023092BD K-4000 MICROKERATOME SYSTEMBecton, Dickinson & CO · 2002-10-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑