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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm June 30, 2005
Date Posted November 16, 2005
Recall Status1 Terminated 3 on February 01, 2007
Recall Number Z-0152-06
Recall Event ID 33965
Product Classification Blade, Scalpel - Product Code GES
Product BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use
Code Information Lot # 4174460, Reorder # 371712
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Greg Morgan
201-884-4344
Manufacturer 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).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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