FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
- Recall number
- Z-2485-2021
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
- Status
- Terminated
- Initiated
- 2021-08-13
- Posted
- not on file
- Terminated
- 2023-08-16
- Reason
- Blood collection tubes may experience a clotting issue.
- Root cause
- Process control
- Action
- A distributor and customer letter dated 08/12/2021 was issued to affected consignees. Customers are advised to stop using the recalled product immediately and quarantine affected product within the facility. Customers are asked to complete a Product Disposition form and return to the recalling firm. The firm issued additional letters dated 9/10/2021 on 9/13/2021 via email to distributors and via USPS to other customers informing them of an additional lot number of product that is affected. The letters provide similar instructions as the initial letter.
- Quantity
- 962,400 tubes
- Distribution
- Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.
- Lot, serial or model codes
- Item Number 456279, Lot B21033DA, exp. 09/08/2022, UDI Case - 39120017571248; UDI Rack - 29120017571241 UPDATE per 9/10/2021 email: Item Number 456279, Lot B21053R8, exp. 11/10/2022, UDI Case -39120017571248; UDI Rack - 29120017571241.
- 510(k) numbers
- ["K971236"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 3001451379
- Firm city
- Monroe
- Firm state
- NC
- 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