Recall Z-0454-2008 ยท HNM Needle, Ophthalmic Suturing
Becton Dickinson and Company
BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Becton, Dickinson and Company, Waltham, MA 02452
| Date | Dec 11, 2007 (initiated Nov 20, 2007) |
| Status | Terminated |
| Reason | No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow |
| Root 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.