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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tubes

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 Class 2 Device Recall BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tubessee related information
Date Initiated by FirmSeptember 18, 2017
Create DateMarch 26, 2018
Recall Status1 Terminated 3 on February 04, 2019
Recall NumberZ-1180-2018
Recall Event ID 78909
510(K)NumberK160657 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductBD Vacutainer Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring and zinc testing in plasma for in vitro diagnostic use.
Code Information All Lot Numbers Expiration Dates: November 30, 2017 - July 31, 2018  UDI No.: 50382903650434 50382903650441 50382903650458 50382903650472 
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
201-847-6800
Manufacturer Reason
for Recall		Increased amount of residual blood present on the top of stopper well after venipuncture
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn September 22, 2017, BD distributed URGENT PRODUCT REMOVAL RECALL notices to distributors via email. Distributors and customers were mailed via USPS. Customers are advised to take to take the following actions: 1. Discontinue use of the tubes. 2. Complete and return the Customer Recall Response Form via fax to 1-855-544-4851 or via email to BD7021@stericycle.com. 3. Return all affected products using the enclosed packaging instructions and include the completed Recall Response Form with the product. Upon receipt of the returned product, BD will issue alternate product. Customers with questions may call 1-855-215-5168, Monday through Friday between 8AM and 5 PM, EST. For further questions, please call (201) 847-6800.
Quantity in Commerce1,976,000 tubes
DistributionUSA (nationwide)
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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