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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Blood Collection

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 Class 2 Device Recall BD Vacutainer Blood Collectionsee related information
Date Initiated by FirmJune 21, 2006
Date PostedSeptember 09, 2006
Recall Status1 Terminated 3 on June 07, 2007
Recall NumberZ-1461-06
Recall Event ID 35831
510(K)NumberK974363 
Product Classification Vacutainer Blood CollectionBlood Collection - Product Code FMI
ProductBD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380.
Code Information Lot numbers: 5326641; 5336280; 5340618; 5341943; 5342548; 5342549; 5348212; 5348215; 5355629; 5357860; 5357891; 6009122; 6020878; 6024334; 6031704; 6040224. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900.  
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactKevin Nolan
201-847-5651
Manufacturer Reason
for Recall		Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
FDA Determined
Cause 2		Other
ActionBD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.
Quantity in Commerce122,7900 units
DistributionWorld wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, New Zealand. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900. Government accounts include the VAMC in Erie, PA;
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMI
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