Recall Z-0960-2022
Huntleigh Healthcare Ltd. · initiated February 11, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Codes / lots: Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)
Reason for recall
Faceplate may become detached from the probe body.
FDA-determined cause: Under Investigation by firm
Action taken
The firm notified their consignees by email beginning on 02/11/2022. The notice explained the issue and requested disposal of the probes on site. Distributors were directed to notify their customers. The firm will replace the affected probes.
Details
- Recall number
- Z-0960-2022
- Initiated
- February 11, 2022
- Terminated
- June 12, 2024
- Product code
- ITX – Transducer, Ultrasonic, Diagnostic
- Quantity
- 150 devices
- Distribution
- US Nationwide distribution in the states of OK, CA, GA, MI, VA.
- Recalling firm
- Huntleigh Healthcare Ltd., Cardiff