Z-0672-2007

BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618

Name: Z-0672-2007 BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618
Creator: Becton Dickinson and Company
Published: 2007-03-02
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2007-03-02 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson and Company began a recall of BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618 on 2007-03-02. The reason FDA records is "Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0672-2007
Status: Terminated
Initiated: 2007-03-02
Posted: 2007-03-29
Terminated: 2008-03-05
Recalling firm: Becton Dickinson & Co
Product: BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618
Product code: KYG Device, Irrigation, Ocular Surgery
Reason for recall: Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
Root cause tag: labeling and UDI
FDA root cause: Other
Action: BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.
Quantity in commerce: 1500 units
Distribution: Nationwide.
Product codes and lots: Lot Number: 6181868

Product code KYG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)