CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

Vacuette Tube K2E K2EDTA pink cap-pink ring, non-ridged recalled

Greiner Bio-One North America is recalling Vacuette Tube K2E K2EDTA pink cap-pink ring, non-ridged, distributed in 15 states. The recall was initiated on 13 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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.

Quantity recalled962,400 tubes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2485-2021
FDA event ID: 88511
Recalling firm: Greiner Bio-One North America, Monroe, NC
Classification: Class II
Status: Terminated
Recall initiated: 13 Aug 2021
FDA classified: 24 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Aug 2021	Recall initiated by company
24 Sep 2021	Classified by FDA	+42 days
6 Oct 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Blood collection tubes may experience a clotting issue.

Product as listed by the FDA

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

Where it was distributed

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.

Alabama Arizona Colorado Connecticut Florida Illinois Massachusetts Maryland Michigan Missouri North Carolina New Mexico Pennsylvania Texas Virginia

Questions about this recall

Why was it recalled?

Blood collection tubes may experience a clotting issue.

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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