FDA-Device2022-04-27Class II

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

Huntleigh Healthcare Ltd.
Hazard

Faceplate may become detached from the probe body.

Sold states
US Nationwide distribution in the states of OK, CA, GA, MI, VA.
Affected count
150 devices
Manufactured in
35 Portmanmoor Road, Cardiff, United Kingdom
Products
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0960-2022

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