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U.S. Department of Health and Human Services

Class 3 Device Recall BardParker RibBack

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  Class 3 Device Recall BardParker RibBack see related information
Date Initiated by Firm August 10, 2007
Date Posted October 02, 2007
Recall Status1 Terminated 3 on March 07, 2008
Recall Number Z-0012-2008
Recall Event ID 39369
Product Classification surgical blade - Product Code GES
Product Shelf Pack:
Bard-Parker Rib-Back Carbon Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417
Code Information Reorder number 371111, Lot 0207321
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Greg Morgan
201-847-4344
Manufacturer Reason
for Recall		 Complaints received of rust on the blades of BD Bard-Parker Surgical blades.
FDA Determined
Cause 2		 Packaging change control
Action Urgent recall letters were sent out 8/10/2007 via UPS second day air.
Quantity in Commerce 4026 units
Distribution Nationwide.
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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