Device product
VACUETTE SAFELINK, REF: 450210
Z-0802-2025
Product summary
- Event
- Event 95748
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 188,800 pcs
- Official record key
device-enforcement:Z-0802-2025
Official wording
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 information: UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215
Distribution pattern: US Nationwide distribution in the states of IL, PA.
Derived failure modes
-
Unknown
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.