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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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  Class 2 Device Recall BD see related information
Date Initiated by Firm February 15, 2007
Date Posted April 05, 2007
Recall Status1 Terminated 3 on July 19, 2007
Recall Number Z-0719-2007
Recall Event ID 37598
510(K)Number K980987  
Product Classification syringe - Product Code FMF
Product BD 30ml Syringe Luer-Lok tip
Sterile
BD, Franklin Lakes, NJ
Made in USA
Code Information Reorder number 309650 Lot numbers 6188613, 6188614
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		 The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.
FDA Determined
Cause 2		 Other
Action Distributors were sent recall notification letters on February 1, 2007 Recall notification letters were sent to all direct accounts and potential end users via UPS second day air on February 15, 2007.
Quantity in Commerce 332,400 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.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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