BD Vacutainer recallZ-1180-2018 · Becton Dickinson & Company · initiated Sep 18, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Increased amount of residual blood present on the top of stopper well after venipuncture
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1180-2018
- Status
- Terminated
- Initiated by the company
- Sep 18, 2017
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 1,976,000 tubes
- Product code
- JKA
- FDA submissions
- K160657
- Distribution
- USA (nationwide)
Product 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.
Code information (models, lots, serial numbers)
All Lot Numbers Expiration Dates: November 30, 2017 - July 31, 2018 UDI No.: 50382903650434 50382903650441 50382903650458 50382903650472
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- BD Vacutainer® 365045Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1 recall6 reports
- BD Vacutainer® 365043Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1 recall5 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K160657 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BD Vacutainer® 365047Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection9 reports
- BD Vacutainer® 365044Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page