HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Pr
Summary
The FDA issued a Class II for HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 by Huntleigh Healthcare Ltd.. Reason: Faceplate may become detached from the probe body..
Details
Source
Device Recall
External ID
Z-0960-2022
Action Date
2022-04-27
Status
Terminated
Category
device
Product Description
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Lot/Code Info: Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)
Quantity Affected: 150 devices
Reason for Recall
Faceplate may become detached from the probe body.
Distribution
US Nationwide distribution in the states of OK, CA, GA, MI, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-11
Company
Cardiff
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Huntleigh Healthcare Ltd. has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Huntleigh Healthcare Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Huntleigh Healthcare Ltd. have FDA actions?
Huntleigh Healthcare Ltd. has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0960-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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