Medical device recalls Moderate risk

Greiner Bio-One GmbH recalls VACUETTE SAFELINK, REF: 450210

Recall date
November 19, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0802-2025
FDA classification
Class II
Brand / firm
Greiner Bio-One GmbH
Sold / distributed
US Nationwide distribution in the states of IL, PA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VACUETTE SAFELINK, REF: 450210

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