Recalls / —

—#54235

Product

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

FDA product code

HMY — Keratome, Battery-Powered

Device class

Class 1

Medical specialty

Ophthalmic

510(k) numbers

K023092

Affected lot / code info

All serial numbers

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm

Becton Dickinson and Company

Address

411 Waverley Oaks Rd, Ste 2229, Waltham, Massachusetts 02452-8448

Distribution

Distribution pattern

Worldwide

Timeline

Recall initiated

2007-08-09

Posted by FDA

2007-10-23

Terminated

2012-02-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #54235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.