Data Foundry

Medical device recalls 2021

VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring — Class II medical device recall Z-2485-2021

Terminated recall by Greiner Bio-One North America, Inc., reported 2021-10-06, distributed in AL, AZ, CO, CT, FL, IL, MA, MD…. Blood collection tubes may experience a clotting issue.

Recall numberZ-2485-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGreiner Bio-One North America, Inc., Monroe, NC, United States
Recall initiated2021-08-13
Classified2021-09-24
Reported by FDA2021-10-06
Terminated2023-08-16
DistributedAL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, VA
Countries outside the USCA
Quantity962,400 tubes
UPC / GTIN / UDI-DI29120017571241, 39120017571248
Lot numbersB21033DA, B21053R8
Model numbers456279
Expiration dates2022-09-08, 2022-11-10

Product

VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

Reason for recall

Blood collection tubes may experience a clotting issue.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2485-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.