FDA Enforcement
Class II
Ongoing
VACUETTE SAFELINK, REF: 450210
Recall: Z-0802-2025
·
Reported January 15, 2025
Enforcement
- Recall Number
- Z-0802-2025
- Event ID
- 95748
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Greiner Bio-One GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 15, 2025
- Initiation Date
- November 19, 2024
- Classification Date
- January 3, 2025
- Address
- Bad Haller Strase 32, Kremsmunster, N/A, Austria
Description
VACUETTE SAFELINK, REF: 450210
Reason
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.
Code Info
UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215
Distribution
US Nationwide distribution in the states of IL, PA.
Quantity
188,800 pcs