—#66408

Product

BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452

FDA product code: HNM — Needle, Ophthalmic Suturing
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: Lot Numbers: 7177806 and 7088657

Why it was recalled

No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow.

Root cause (FDA determination)

Process control

Action the firm took

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)

Recalling firm

Firm: Becton Dickinson and Company
Address: 411 Waverley Oaks Rd, Ste 2229, Waltham, Massachusetts 02452-8448

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2007-11-20
Posted by FDA: 2007-12-11
Terminated: 2012-02-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.