Recall Z-0960-2022— Huntleigh Healthcare Ltd.

Name: FDA recall Z-0960-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-11

Class II · Terminated

Class II FDA medical device recall by Huntleigh Healthcare Ltd., initiated 2022-02-11, terminated 2024-06-12. It names one FDA 510(k) clearance: K201425. Product: HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8. Reason: Faceplate may become detached from the probe body..

Recalling firm: Huntleigh Healthcare Ltd.
Classification: Class II
Status: Terminated
Initiated: 2022-02-11
Terminated: 2024-06-12
Firm location: Cardiff, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K201425 — Disposable Intraoperative Probe (DIOP8)Huntleigh Healthcare Limited·cleared 2021-02-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.