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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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 Class 2 Recall
BD
see related information
Date Posted April 05, 2007
Recall Status1 Terminated on July 19, 2007
Recall Number Z-0719-2007
Recall Event ID 37598
Product Classification Syringe, Piston - 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, New Jersey 07417-1815
Consumer Instructions No consumer action necessary
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
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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