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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Plus plastic whole Blood Collection Tubes

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 Class 2 Device Recall BD Vacutainer Plus plastic whole Blood Collection Tubessee related information
Date Initiated by FirmNovember 17, 2015
Date PostedDecember 21, 2015
Recall Status1 Terminated 3 on June 08, 2016
Recall NumberZ-0456-2016
Recall Event ID 72700
510(K)NumberK981013 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductBD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
Code Information Catalog (Ref) # 367856; Lot Number 5014806
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactMs. Zuleika S¿nchez
201-847-5216
Manufacturer Reason
for Recall		Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
FDA Determined
Cause 2		Under Investigation by firm
ActionBD sent an "Urgent Product Recall notifications/Recall Response Forms dated November 17, 2015 via email and/or UPS Next Day Mail on November 17, 2015 to their customers. The notification identifies the affected product and problem and actions to be taken. Customers are requested to take the following actions (1) Immediately review their inventory and quarantine the product subject to the recall and immediately discontinue the shipment of the affected product (2) complete the enclosed Recall Response Firm and fax it bat to BD at 1.866.873.0312 or emai to bd8554@stericycle.com (3) Return all affected products with the completed Recall Response Form following the instruction on the enclosed packing instruction and (5) if distributed, identify your customers and notify them immediately of this product recall. If the customers had any questions, they were instructed to contact BD at 1.888.628.0732 between 8 AM and 5 PM Monday through Friday.
Quantity in Commerce4,835,000 units
DistributionWorldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.
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 = JKA
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