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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 11, 2005
Date Posted August 30, 2005
Recall Status1 Terminated 3 on June 29, 2006
Recall Number Z-1423-05
Recall Event ID 32808
510(K)Number K990188  
Product Classification Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
Product BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve.
Code Information Catalog #364880, Lot #5076799, Exp 2/2008; #50076797, exp. 2/2008; #5976798, Exp 2/2008; #5098260, Exp 3/2008; #5112114, Exp 3/2008. 
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Kevin Nolan
201-847 Ext. 5651
Manufacturer Reason
for Recall		 Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.
FDA Determined
Cause 2		 Other
Action A customer communication was sent by first class mail on 7/26/05, advising all consignees of the problem. The letter asks each customer to immediately examine their inventory for affected lot numbers, return product from affected lots using enclosed label and packing slip, and to notify all of their affected customers to alert them to the situation.
Quantity in Commerce 641200 eaches
Distribution Worldwide
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 = INTUITIVE SURGICAL, INC.
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