BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection… recallZ-0456-2016 · Becton Dickinson & Company · initiated Nov 17, 2015
Class II Terminated All recalls posted in December 2015
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
Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
FDA root cause category: Under Investigation by firm
What the company is doing
BD sent an "Urgent Product Recall notifications/Recall Response Forms dated November 17, 2015 via email and/or UPS Next Day Mail on November 17, 2015 to their customers. The notification identifies the affected product and problem and actions to be taken. Customers are requested to take the following actions (1) Immediately review their inventory and quarantine the product subject to the recall and immediately discontinue the shipment of the affected product (2) complete the enclosed Recall Response Firm and fax it bat to BD at 1.866.873.0312 or emai to [email protected] (3) Return all affected products with the completed Recall Response Form following the instruction on the enclosed packing instruction and (5) if distributed, identify your customers and notify them immediately of this product recall. If the customers had any questions, they were instructed to contact BD at 1.888.628.0732 between 8 AM and 5 PM Monday through Friday.
Recall details
- Recall number
- Z-0456-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 17, 2015
- Posted by the FDA
- Dec 21, 2015
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 4,835,000 units
- Product code
- JKA
- FDA submissions
- K981013
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.
Product description
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
Code information (models, lots, serial numbers)
Catalog (Ref) # 367856; Lot Number 5014806
Other devices under the same FDA submission
1 device cleared under K981013 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD Vacutainer® Serum Blood Collection Tubes 367815Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection462 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 18, 2026. Text above is shown as published by the FDA.
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