Medical device recalls Moderate risk

Richard Wolf GmbH recalls RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

Recall date
March 11, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1868-2018
FDA classification
Class II
Brand / firm
Richard Wolf GmbH
Sold / distributed
Worldwide Distribution

Why it was recalled

Tube ends may be mixed up.

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

What was recalled

RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

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