FDA Recall Terminated

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

Recall: Z-2495-2021 · Initiated August 9, 2021

Recall

Recall Number
Z-2495-2021
Event Number
88590
Firm
Ad-Tech Medical Instrument Corporation
FEI Number
2183456
Product Code
IKD
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
August 9, 2021
Terminated
January 13, 2023
Address
400 W Oakview Pkwy, Oak Creek, WI, 53154-7213

Description

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

Reason

Incorrect version of labels were used.

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.

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.

Quantity

10