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BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes recallZ-0968-2018 · Becton Dickinson & Company · initiated Aug 29, 2017

Terminated

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

A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.

FDA root cause category: Under Investigation by firm

What the company is doing

In August of 2017 All US direct consignees were contacted via e-mail and/or UPS mail. An Urgent Product Removal Recall letter was issued, identifying the affected device and the reason for the recall. It also requested customers to review their inventory and quarantine any affected devices, which will be returned to the firm for replacement. The Customer Recall Response Form should be completed and returned regardless of whether there is any affected devices on hand. For questions or concerns please contact Customer Service at 1-855-215-4992.

Recall details

Recall number
Z-0968-2018
Status
Terminated
Initiated by the company
Aug 29, 2017
Recalling firm
Becton Dickinson & Company
Quantity
8,494,000
Product code
JKA
FDA submissions
BK050036
Distribution
Nationwide Distribution

Product description

BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.

Code information (models, lots, serial numbers)

Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

31 devices cleared under BK050036 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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