Skip to content

BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes 367843

by Becton, Dickinson and Company

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30382903678434 UDI-DI Date27 Jan 2026ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1618-2022 FDA Class II initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

    • Terminated Z-0968-2018 FDA Class II initiated 29 Aug 2017

    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.

    • Terminated Z-2434-2015 FDA Class III initiated 23 Jun 2015

    Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes
Generic Name
Evacuated blood collection tube IVD, anticoagulant
Model / Ref / Catalog
367843
Primary DI / UDI-DI
30382903678434
FDA Product Code
JKA
GMDN Term
Evacuated blood collection tube IVD, anticoagulant
Device Class
Class II
Regulation Number
862.1675
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 2 Milliliter
Length — 75 Millimeter

Related devices

Cleared under the same submission (BK050036)

Show all (12)

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No