Z-0453-2008

BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton...

Name: Z-0453-2008 BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton...
Creator: Becton Dickinson and Company
Published: 2007-11-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2007-11-20 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson and Company began a recall of BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452 on 2007-11-20. The reason FDA records is "No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow". 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-0453-2008
Status: Terminated
Initiated: 2007-11-20
Posted: 2007-12-11
Terminated: 2012-02-29
Recalling firm: Becton Dickinson & Co
Product: BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452
Product code: HNM Needle, Ophthalmic Suturing
Reason for recall: No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm notified consignees of the recall through a Voluntary Medical Device Recall letter and phone call on 11/20/2007. Instructions for product return were provided and a telephone number for questions was given (Customer Service 1-866-906-8080 Option 2)
Quantity in commerce: 40,450
Distribution: Nationwide-USA including the states of CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MO, NC, NJ, NY, OH, PA, SC, TN, VA, and WA
Product codes and lots: Lot Numbers: 7177806 and 7088657

Product code HNM

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)