Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party
Summary
The FDA issued a Class II for Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of co by Ad-Tech Medical Instrument Corporation. Reason: Incorrect version of labels were used..
Details
Source
Device Recall
External ID
Z-2494-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Lot/Code Info: Item Code & Lot #: L-SRL-10DIN Lot #'s 120340, 122140 and 124140; L-SRL-10DIN-84 Lot #'s 126270 and 127270; L-SRL-12BDIN Lot # 125250; L-SRL-16BDINLot #124150; L-SRL-20DINLot # 127060; L-SRL-32BDIN Lot # 126070 L-SRL-4DIN Lot #'s 123050, 129150 and 120250; L-SRL-64BDIN Lot #127270; L-SRL-6DINLot #'s 128060 and 120160; L-SRL-8DIN Lot #'s 128150 and 124050; L-SRL-8DIN-11 Lot # 125170
Quantity Affected: 69
Reason for Recall
Incorrect version of labels were used.
Distribution
Worldwide distribution - US Nationwide distribution in the states of DC, FL, MI, NY, PA and TX and the countries of Spain, France, Italy, Greece, Great Britain and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-09
Company
Oak Creek, WI
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 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ad-Tech Medical Instrument Corporation has 8 FDA actions in our database, including 6 recalls 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 (Ad-Tech Medical Instrument Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ad-Tech Medical Instrument Corporation have FDA actions?
Ad-Tech Medical Instrument Corporation has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2494-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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