Medical device recalls Moderate risk

Huntleigh Healthcare Ltd. recalls HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative P…

Recall date
February 11, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0960-2022
FDA classification
Class II
Brand / firm
Huntleigh Healthcare Ltd.
Sold / distributed
US Nationwide distribution in the states of OK, CA, GA, MI, VA.

Why it was recalled

Faceplate may become detached from the probe body.

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

What was recalled

HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8

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