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.
Recall
- Recall Number
- Z-1503-2016
- Event Number
- 73685
- Firm
- Ad-Tech Medical Instrument Corporation
- FEI Number
- 2183456
- Product Code
- IKD
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- March 29, 2016
- Posted
- April 15, 2016
- Terminated
- August 24, 2016
- Address
- 1901 William St, Racine, WI, 53404-1876
Description
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.
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.
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 [email protected]; FAX: 262-634-5668 or Telephone 262-634-1555. For questions contact Ad-Tech Clinical Specialist. .
Distributed in the states of GA and MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and BRAZIL.
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