Z-2494-2021Class II

Ad-Tech Lightweight CABRIO Cable -

Name: Z-2494-2021 Ad-Tech Lightweight CABRIO Cable -
Creator: Ad-Tech Medical Instrument Corporation
Published: 2021-08-09
License: https://open.fda.gov/license/

AD-Tech Medical Instrument Corp. / initiated 2021-08-09 / Terminated / root cause: labeling and UDI

FDA source

Ad-Tech Medical Instrument Corporation began a recall of Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators on 2021-08-09. FDA classified it as Class II and gives the reason as "Incorrect version of labels were used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2494-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-09
Posted: 2021-09-20
Terminated: 2023-01-13
Recalling firm: AD-Tech Medical Instrument Corp.
Product: Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Product code: IKD Cable, Electrode
Reason for recall: Incorrect version of labels were used.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Consignees were sent a "Medical Device Recall" letter dated August 09, 2021. The letter described the problem and the product being recalled. Advised consignees to immediately examine their inventory, quarantine and return the product to AD-Tech. If the product has been further distributed identify customers and notify them of the recall. Requested consignees to complete and return the "Medical Device Recall Return Response" form to their Ad-Tech Clinical Specialist at [email protected]; FAX: 262-634-5668 or Telephone 800-776-1555. For questions contact Ad-Tech Clinical Specialist.
Quantity in commerce: 69
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2494-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2494-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-20
Z-2495-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-20
Z-2496-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-20

Product code IKD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)