Greiner Bio-One GmbH: Device Recall

Recall #Z-0802-2025 · 11/19/2024

Class II: Risk

Recall Details

Recall Number
Z-0802-2025
Classification
Class II
Product Type
Device
Recalling Firm
Greiner Bio-One GmbH
Status
Ongoing
Date Initiated
11/19/2024
Location
Kremsmunster, Austria
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
188,800 pcs

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.

Product Description

VACUETTE SAFELINK, REF: 450210

Distribution Pattern

US Nationwide distribution in the states of IL, PA.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.