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U.S. Department of Health and Human Services

Class 2 Device Recall Lightweight CABRIO Cable

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  Class 2 Device Recall Lightweight CABRIO Cable see related information
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
Recalling Firm/
Manufacturer		 Ad-Tech Medical Instrument Corporation
400 W Oakview Pkwy
Oak Creek WI 53154-7213
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.
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
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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