—#72739

Product

BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref: 581440 Used during cataract and other ophthalmic surgery procedures to grasp lens capsule.

FDA product code: HNR — Forceps, Ophthalmic
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: Lot Number: 8067450 Exp. Date: March 2011

Why it was recalled

Metal particulates present.

Root cause (FDA determination)

Manufacturing material removal

Action the firm took

BD notified customers by telephone via a script on July 7, 2008 and requested customers to examine their inventory, dispose of product, and replacement product would be provided.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution --- including states of CA, IL, KY, MS, PA, and TX.

Timeline

Recall initiated: 2008-07-07
Posted by FDA: 2008-09-19
Terminated: 2012-02-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72739. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.