Class 2 Device Recall BD Visitec Nucleus Hydrodissector

• Date Initiated by Firm: November 20, 2007
• Date Posted: December 11, 2007
• Recall Status: Terminated 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/ Manufacturer: Becton Dickinson and Company; 411 Waverley Oaks Rd Ste 2229; Waltham MA 02452-8448
• For Additional Information Contact: Same; 781-906-7950
• 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: 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.