FDA Medical devices recall ·
VACUETTE SAFELINK recall
- Recall number
- Z-0802-2025
- Date
- (initiated November 19, 2024)
- Company / brand
- Greiner Bio-One GmbH
Bad Haller Strase 32, Kremsmunster, Austria - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 188,800 pcs
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VACUETTE SAFELINK, REF: 450210
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215
Distribution
US Nationwide distribution in the states of IL, PA.
States: Illinois Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0802-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.