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Terminated

Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

FDA Recall Z-2495-2021 · Posted None

Recalling FirmAd-Tech Medical Instrument Corporation
Recall StatusTerminated
Product CodeIKD
Date Initiated2021-08-09
Date Terminated2023-01-13
Product Quantity10

Reason for Recall

Incorrect version of labels were used.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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