—#160838

Product

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 product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K160657
Affected lot / code info: All Lot Numbers Expiration Dates: November 30, 2017 - July 31, 2018 UDI No.: 50382903650434 50382903650441 50382903650458 50382903650472

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: USA (nationwide)

Timeline

Recall initiated: 2017-09-18
Terminated: 2019-02-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160838. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.