Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Becton, Dickinson and Company, Waltham, MA 02452

FDA Recall Z-0454-2008 · Posted 2007-12-11

Recalling FirmBecton Dickinson and Company
Recall StatusTerminated
Product CodeHNM
Date Initiated2007-11-20
Date Terminated2012-02-29
Product Quantity43,000

Reason for Recall

No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow

Firm 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)

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

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

↑