Recall Z-1180-2018 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
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.
| Date | Sep 18, 2017 |
| Status | Terminated |
| Reason | Increased amount of residual blood present on the top of stopper well after venipuncture |
| Root cause | Nonconforming Material/Component |
| 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 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 |
| Quantity | 1,976,000 tubes |
| Distribution | USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160657 | BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube Becton, Dickinson and Company, Sep 23, 2016 |