FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA 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.
- Recall number
- Z-0568-2016
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA 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.
- Status
- Terminated
- Initiated
- 2015-12-03
- Posted
- 2015-12-31
- Terminated
- 2018-10-19
- Reason
- Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
- Root cause
- Process change control
- Action
- The firm, BD, issued an "URGENT PRODUCT RECALL" notifications/Recall Response Forms to their customers dated 12/3/2015 via email and/or UPS 2nd Day Mail. The notification identified the reason for the recall; how to identify affected product; and actions to be taken. The customers were instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-866-873-0312 it to BD or email it to bd4964@stericycle.com; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction, even if you do not have any affected lot in your inventory. If customers have any questions or require assistance with the return of the recalled product and/or availability of replacement product, they were instructed to contact 1-888-628-0732 between 8AM and 5 PM ET Monday through Friday.
- Quantity
- 29,815,600 units in total
- Distribution
- Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
- Lot, serial or model codes
- Catalog Reference #368047; Lot number 5154647
- 510(k) numbers
- ["K981013"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28