Z-0802-2025 Class II Ongoing
FDA device recall Z-0802-2025 was initiated by Greiner Bio-One GmbH on November 19, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 188,800 pcs.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2025
- Initiation Date
- November 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188,800 pcs
Product Description
VACUETTE SAFELINK, REF: 450210
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.
Distribution Pattern
US Nationwide distribution in the states of IL, PA.
Code Information
UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215