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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Luer Adapter

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  Class 2 Device Recall BD Vacutainer Luer Adapter see related information
Date Initiated by Firm June 21, 2006
Date Posted September 09, 2006
Recall Status1 Terminated 3 on June 07, 2007
Recall Number Z-1462-06
Recall Event ID 35831
510(K)Number K991088  
Product Classification Vacutainer Luer Adapter - Product Code JKA
Product BD Vacutainer Luer Adapter; Catalog #367290 and #367300.
Code Information Catalog No: 367290 Lot Number 5305585; Catalog No: 367300 Lot Numbers 5307894; 5307896; 5307900. 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 Contact Kevin 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
Action BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.
Quantity in Commerce 3,324,000 units
Distribution World 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 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 = JKA and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS
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