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Terminated

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

FDA Recall Z-0152-06 · Posted 2005-11-16

Recall StatusTerminated
Product CodeGES
Date Initiated2005-06-30
Date Terminated2007-02-01
Product Quantity11,900 units were distributed

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).

Firm 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.

Root Cause

Other

Distribution Pattern

Product was distributed to 9 distributors nationwide and then to end users.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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