CLASS II ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report
Vacuette Safelink recalled by Greiner Bio-One
Greiner Bio-One is recalling Vacuette Safelink, distributed nationwide in the US. The recall was initiated on 19 Nov 2024 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-0802-2025
- FDA event ID
- 95748
- Recalling firm
- Greiner Bio-One, Kremsmunster
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Nov 2024
- FDA classified
- 3 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 19 Nov 2024 | Recall initiated by company | |
| 3 Jan 2025 | Classified by FDA | +45 days |
| 15 Jan 2025 | 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 SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
VACUETTE SAFELINK, REF: 450210
Where it was distributed
US Nationwide distribution in the states of IL, PA.
Questions about this recall
Why was it recalled?
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Which lots are affected?
UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215
Where was it sold?
US Nationwide distribution in the states of IL, PA.
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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