Medical device recalls Moderate risk

OriGen Biomedical, Inc. recalls 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

Recall date
June 24, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0318-2021
FDA classification
Class II
Brand / firm
OriGen Biomedical, Inc.
Sold / distributed
US: TX

Why it was recalled

The firm has become aware that they have distributed product that was expired.

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

What was recalled

3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

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