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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 April 19, 2005
Date Posted August 03, 2005
Recall Status1 Terminated 3 on October 03, 2006
Recall Number Z-1075-05
Recall Event ID 32005
Product Classification Blade, Scalpel - Product Code GES
Product BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposable, stainless steel blade. Reorder Number 371631.
Code Information Lot Number 4322604.
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		 A small percentage of scalpels exhibited a 'double blade' condition.
FDA Determined
Cause 2		 Other
Action Letters were sent to all customers and all customers have also been contacted by phone. Letters were sent on 4/49/2005.
Quantity in Commerce 48000 units
Distribution The scalpels were distributed to kit manufacturers. These include: Cardinal Health, 1300 Waukegan Road, McGaw Park, Il 60085; Bard Health Care, 201 West Anaya Road, Hidalgo, TX 78577; Edwards Lifesciences, 6864 South 300 West, Salt Lake City, UT 84047; Avid Medical, 900 Westmount Dr., James City, VA 23168; DeRoyal Industries, PO Box 1667, Knoxville, TN 37849; Boston Scientific, 780 Brookside Dr., Owen, IN 47460; Medikmark, 3600 Burwood Dr., Waukegan Lake, IL 60085; CustoMed/Puerto Rico Hospital Supply, Carolina, PR 00987.
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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