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Terminated

BD K-3000 Microkeratome Blade REF 378607

FDA Recall Z-0634-03 · Posted 2003-03-12

Recalling FirmBD Opthalmic Systems
Recall StatusTerminated
Product CodeHMY
Date Initiated2003-01-24
Date Terminated2003-04-28
Product Quantity1539 Blades

Reason for Recall

Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022637BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOMEBecton, Dickinson & CO · 2002-10-16

Official Source

View FDA Recall →

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

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