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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set

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  Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set see related information
Date Initiated by Firm August 08, 2016
Create Date September 01, 2016
Recall Status1 Terminated 3 on November 20, 2017
Recall Number Z-2710-2016
Recall Event ID 74909
510(K)Number K030573  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
Code Information Lot number: 5355531, 5355533, 5356681, 5356682, 6006629, 6006630, 6006631, 6006633, 6006634 and 6006650.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Mr. Matthew Kelleher
201-847-6910
Manufacturer Reason
for Recall		 Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts the needle.
FDA Determined
Cause 2		 Under Investigation by firm
Action BD notified their customers via e-mail and sent an "Urgent Product Recall Letter" and a Recall Response Form dated August 8, 2016 via UPS.
Quantity in Commerce 1,788,150 units
Distribution US and International
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 = BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
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