Z-0634-03

BD K-3000 Microkeratome Blade REF 378607

Name: Z-0634-03 BD K-3000 Microkeratome Blade REF 378607
Creator: BD Opthalmic Systems
Published: 2003-01-24
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2003-01-24 / Terminated

FDA source

BD Opthalmic Systems began a recall of BD K-3000 Microkeratome Blade REF 378607 on 2003-01-24. The reason FDA records is "Microkeratome Blade may cause irregular corneal flap which may delay patients procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0634-03
Status: Terminated
Initiated: 2003-01-24
Posted: 2003-03-12
Terminated: 2003-04-28
Recalling firm: Becton Dickinson & Co
Product: BD K-3000 Microkeratome Blade REF 378607
Product code: HMY Keratome, Battery-Powered
Reason for recall: Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.
FDA root cause: 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
Product codes and lots: Manufacturing Lot Numbers: 959, 962, 964, 965, and 966

Product code HMY

K022637Class IBd-3000 Microkeratome System, Model K-3000 MicrokeratomeBecton, Dickinson & CO / cleared 2002-10-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)