CLASS II Device recall · Reported 27 Feb 2013 · FDA Enforcement Report
Vacuette Safety Blood Collection Set + Luer Adapter recalled
Greiner Bio-One North America is recalling Vacuette Safety Blood Collection Set + Luer Adapter, " Safety Blood Collect LA Product, distributed nationwide in the US. The recall was initiated on 1 Feb 2013 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-0835-2013
- FDA event ID
- 64321
- Recalling firm
- Greiner Bio-One North America, Monroe, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Feb 2013
- FDA classified
- 15 Feb 2013
- Reported
- 27 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 1 Feb 2013 | Recall initiated by company | |
| 15 Feb 2013 | Classified by FDA | +14 days |
| 27 Feb 2013 | 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
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
Where it was distributed
US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
Nationwide FloridaIllinoisKentuckyNorth CarolinaNew YorkOhioPennsylvaniaTexasVirginia
Questions about this recall
Why was it recalled?
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Which lots are affected?
Lot No. 12H27
Where was it sold?
US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
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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