Z-0960-2022 Class II Terminated
FDA device recall Z-0960-2022 was initiated by Huntleigh Healthcare Ltd. on February 11, 2022 and is designated Class II. Reason for recall: Faceplate may become detached from the probe body. The recall status is terminated (terminated June 12, 2024). Affected quantity: 150 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- February 11, 2022
- Termination Date
- June 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 devices
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.
Distribution Pattern
US Nationwide distribution in the states of OK, CA, GA, MI, VA.
Code Information
Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)