Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Summary
The FDA issued a Class II for Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46 by Technomed Europe. Reason: Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IF.
Details
Source
Device Recall
External ID
Z-1737-2022
Action Date
2022-09-21
Status
Terminated
Category
device
Product Description
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Lot/Code Info: Lot numbers 044220, exp. 1/1/2023; 045077, exp. 3/1/2023; 045443, exp. 4/1/2023; and 049285, exp. 7/1/2024; UDI-DI 08718375861530.
Quantity Affected: 37/25-electrode boxes
Reason for Recall
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
Distribution
US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-09
Company
Maastricht-Airport
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 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Technomed Europe has 6 FDA actions in our database, including 3 recalls and 3 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 (Technomed Europe) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Technomed Europe have FDA actions?
Technomed Europe has 6 FDA actions in our database, including 3 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1737-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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