BD 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.
FDA Recall Z-1180-2018 · Posted None
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2017-09-18
Date Terminated2019-02-04
Product Quantity1,976,000 tubes
Reason for Recall
Increased amount of residual blood present on the top of stopper well after venipuncture
Firm Action
On 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 [email protected].
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA (nationwide)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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