CLASS II Device recall · Reported 26 Jan 2022 · FDA Enforcement Report
greiner bio-one Vacuette Tube LH Lithium Heparin Sep recalled
Greiner Bio-One North America is recalling greiner bio-one Vacuette Tube LH Lithium Heparin Sep, green cap-yellow ring, non-ridged, distributed in 10 states. The recall was initiated on 9 Dec 2021 and the FDA has classified it as Class II.
Check your package
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-0502-2022
- FDA event ID
- 89216
- Recalling firm
- Greiner Bio-One North America, Monroe, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2021
- FDA classified
- 18 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Dec 2021 | Recall initiated by company | |
| 18 Jan 2022 | Classified by FDA | +40 days |
| 26 Jan 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
Product as listed by the FDA
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
Where it was distributed
Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.
FloridaIllinoisMissouriNorth CarolinaNew MexicoNew YorkPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
Which lots are affected?
Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.
Where was it sold?
Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.
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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