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Class 2 Device Recall BD Visitec Nucleus Hydrodissector |
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| 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/
Manufacturer |
Becton Dickinson and Company
411 Waverley Oaks Rd Ste 2229
Waltham MA 02452-8448
|
| For Additional Information Contact |
Same
781-906-7950
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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
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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.
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