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U.S. Department of Health and Human Services

Class 2 Device Recall BD Visitec Nucleus Hydrodissector

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  Class 2 Device Recall BD Visitec Nucleus Hydrodissector see related information
Date Initiated by Firm November 20, 2007
Date Posted December 11, 2007
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0454-2008
Recall Event ID 45887
Product Classification Hydrodissector - Product Code HNM
Product BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Becton, Dickinson and Company, Waltham, MA 02452
Code Information Lot Numbers: 7188690 and 7088612
Recalling Firm/
Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham MA 02452-8448
For Additional Information Contact Same
Manufacturer Reason
for Recall
No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow
FDA Determined
Cause 2
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 43,000
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.