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BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x recallZ-0571-2016 · Becton Dickinson & Company · initiated Dec 3, 2015

Class II Terminated All recalls posted in December 2015

Is my device affected?

  1. 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.
  2. 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.
  3. 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 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.

FDA root cause category: Process change control

What the company is doing

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 [email protected]; 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.

Recall details

Recall number
Z-0571-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 3, 2015
Posted by the FDA
Dec 31, 2015
Recalling firm
Becton Dickinson & Company
Quantity
29,815,600 units in total
Product code
JKA
FDA submissions
K981013
Distribution
Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

Product description

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg 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.

Code information (models, lots, serial numbers)

Catalog Reference #367844; Lot number 5154624  Catalog Reference #367862; Lot numbers 5089771 and 5187753  Catalog Reference #368021; Lot number 5089820

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 72868).

Sources and updates

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