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

FDA device recall Z-0453-2008 · posted 2007-12-11 · Terminated

Recall details

Recalling firm

Becton Dickinson and Company

Reason for recall

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

Action taken

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

Status

Terminated

Product code

HNM

Quantity affected

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

Date initiated

2007-11-20

Date posted

2007-12-11

Date terminated

2012-02-29

Location

Waltham, MA