FDA recall Z-0960-2022

Huntleigh Healthcare Ltd. · Class II · device

Product

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

Reason for recall

Faceplate may become detached from the probe body.

Distribution

US Nationwide distribution in the states of OK, CA, GA, MI, VA.

Key facts

Status
Terminated
Initiation date
2022-02-11
Report date
2022-04-27
Termination date
2024-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cardiff, United Kingdom

Primary source

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