Date Initiated by Firm | August 09, 2021 |
Create Date | September 20, 2021 |
Recall Status1 |
Terminated 3 on January 13, 2023 |
Recall Number | Z-2494-2021 |
Recall Event ID |
88590 |
Product Classification |
Cable, electrode - Product Code IKD
|
Product | Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. |
Code Information |
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
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Recalling Firm/ Manufacturer |
Ad-Tech Medical Instrument Corporation 400 W Oakview Pkwy Oak Creek WI 53154-7213
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For Additional Information Contact | 800-776-1555 |
Manufacturer Reason for Recall | Incorrect version of labels were used. |
FDA Determined Cause 2 | 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 Specialist.
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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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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