Z-0022-2009

BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery

Name: Z-0022-2009 BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery
Creator: Becton Dickinson and Company
Published: 2008-09-15
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2008-09-15 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson and Company began a recall of BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery on 2008-09-15. The reason FDA records is "Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0022-2009
Status: Terminated
Initiated: 2008-09-15
Posted: 2008-10-03
Terminated: 2012-02-29
Recalling firm: Becton Dickinson & Co
Product: BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Product code: HMX Cannula, Ophthalmic
Reason for recall: Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.
Quantity in commerce: 1485 units
Distribution: AZ, CA, CO, IL, OH, FL, PA , TN, TX,and VA Foreign: Australia and Japan.
Product codes and lots: Lot Number: 8018591

Product code HMX

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)