FDA Recall Terminated

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.

Recall: Z-1180-2018 · Initiated September 18, 2017

Recall

Recall Number
Z-1180-2018
Event Number
78909
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
JKA
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
September 18, 2017
Terminated
February 4, 2019
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

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.

Reason

Increased amount of residual blood present on the top of stopper well after venipuncture

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.

Distribution

USA (nationwide)

Quantity

1,976,000 tubes