Summary
The FDA issued a Class II for 48" Lead Wires, Replacement Part Number: 1067724-4 by EBI, LLC. Reason: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being de.
Details
Source
Device Recall
External ID
Z-1619-2024
Action Date
2024-05-01
Status
Ongoing
Category
device
Product Description
48" Lead Wires, Replacement Part Number: 1067724-4
Lot/Code Info: UDI-DI: 00812301020324 All devices distributed since May 1, 2023
Quantity Affected: 594 units (2 lead wires assembly)
Reason for Recall
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-22
Company
Parsippany, NJ
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 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
EBI, LLC has 4 FDA actions in our database, including 4 recalls.
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 (EBI, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does EBI, LLC have FDA actions?
EBI, LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1619-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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