Recall Z-0454-2008
Becton Dickinson and Company · initiated November 20, 2007
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
Codes / lots: Lot Numbers: 7188690 and 7088612
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 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)
Details
- Recall number
- Z-0454-2008
- Initiated
- November 20, 2007
- Posted by FDA
- December 11, 2007
- Terminated
- February 29, 2012
- Product code
- HNM – Needle, Ophthalmic Suturing
- 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
- Recalling firm
- Becton Dickinson and Company, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0453-2008 | BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF…No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow. | 11/20/2007Terminated |