Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0152-06

BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use

Becton Dickinson & Co / initiated 2005-06-30 / Terminated / root cause: labeling and UDI

Becton Dickinson & Company began a recall of BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use on . The reason FDA records is "BD received reports of unit packages labeled with the incorrect blade edge. The incorrectly labeled unit packages indicate a '12' (single edged blade) is present, the actual blade present is a '12B' (double edged blade)". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0152-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use
Product code
GES Blade, Scalpel
Reason for recall
BD received reports of unit packages labeled with the incorrect blade edge. The incorrectly labeled unit packages indicate a '12' (single edged blade) is present, the actual blade present is a '12B' (double edged blade).
Root cause tag
labeling and UDI
FDA root cause
Other
Action
A urgent product recall was sent to distributors on 6/30/2005 by first class mail. End users were then identified and recall notifications were also sent to them. by first class mail.
Quantity in commerce
11,900 units were distributed
Distribution
Product was distributed to 9 distributors nationwide and then to end users.
Product codes and lots
Lot # 4174460, Reorder # 371712