Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2433-2008

BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref: 581440 Used during...

Becton Dickinson & Co / initiated 2008-07-07 / Terminated / root cause: manufacturing process

Becton Dickinson and Company began a recall of BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref: 581440 Used during cataract and other ophthalmic surgery procedures to... on . The reason FDA records is "Metal particulates present". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2433-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref: 581440 Used during cataract and other ophthalmic surgery procedures to grasp lens capsule.
Product code
HNR Forceps, Ophthalmic
Reason for recall
Metal particulates present.
Root cause tag
manufacturing process
FDA root cause
Manufacturing material removal
Action
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.
Quantity in commerce
260 units
Distribution
Nationwide Distribution --- including states of CA, IL, KY, MS, PA, and TX.
Product codes and lots
Lot Number: 8067450 Exp. Date: March 2011