FDA recall Z-0802-2025

Greiner Bio-One GmbH · Class II · device

Product

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

US Nationwide distribution in the states of IL, PA.

Key facts

Status: Ongoing
Initiation date: 2024-11-19
Report date: 2025-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Kremsmunster, Austria

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0802-2025