Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
This recall has been terminated (originally issued August 9, 2021).
- Recall Initiated
- August 9, 2021
- Terminated
- January 13, 2023
- Recall Number
- Z-2494-2021
- Quantity
- 69
- Firm Location
- Oak Creek, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect version of labels were used.
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.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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.