Class 2 Device Recall AdTech Electrode Connection System/Cables

• Date Initiated by Firm: March 29, 2016
• Date Posted: April 15, 2016
• Recall Status: Terminated on August 24, 2016
• Recall Number: Z-1503-2016
• Recall Event ID: 73685
• Product Classification: Electrode, depth - Product Code IKD
• Product: Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: ; 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); ; 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); ; 3. L-DCL-8DINX (8 contacts: 1 terminal block with 8 connectors each); ; 4. L-DCL-16BDINX (16 contacts: 1 terminal block with 16 connectors each); ; 5. L-DCL-32BDINX (32 contacts: 2 terminal blocks with 16 connectors each); ; 6. L-DCL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). ; FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts: 1 terminal block with 4 connectors each).; Tech-Attach: these cables require the use of an additional component - the connector block. The tail of the electrode is inserted into the block and the block in turn mates with the cable. A key-pin is used to ensure proper orientation. The cable terminated in EEG compatible connector sockets.; ; Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached. The tail of an electrode is inserted into this portion which then hinges shut.
• Code Information: Lot Numbers: 208140507, 208140552, 208140556, 208140559, 208140560, 208140561, 208140562, 208140563, 208140564R, 208140579, 208140581, 208140586, 208140588R, 208140590, 208140604.
• Recalling Firm/ Manufacturer: Ad-Tech Medical Instrument Corporation; 1901 William St; Racine WI 53404-1876
• For Additional Information Contact: 262-634-1555
• Manufacturer Reason for Recall: Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. This recall has been initiated due to package failures (i.e. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.
• FDA Determined Cause: Package design/selection
• Action: Consignees were sent a "Medical Device Recall" letter dated March 29, 2016. 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 262-634-1555. For questions contact Ad-Tech Clinical Specialist. .
• Quantity in Commerce: 197
• Distribution: Distributed in the states of GA and MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and BRAZIL.
• 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.