Recall Z-2494-2021 ยท IKD Cable, Electrode
Ad-Tech Medical Instrument Corporation
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
| Date | Aug 9, 2021 |
| Status | Terminated |
| Reason | Incorrect version of labels were used. |
| 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 customersupport@adtechmedical.com; FAX: 262-634-5668 or Telephone 800-776-1555. For questions contact Ad-Tech Clinical Spec |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.