PlainRecordsFDA · Medical device recall
Ad-Tech Lightweight CABRIO Cable… and 2 more products
- Date
- Sept. 29, 2021
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Ad-Tech Medical Instrument Corporation
- Reason
- Incorrect version of labels were used.
- Distribution pattern
- 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.
3 products in this recall
Ad-Tech Lightweight CABRIO Cable…
- Product
- Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
- Quantity
- 69
- Codes and lots
- 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
- Recall started
- Aug. 9, 2021
- Device type
- Cable, Electrode
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-2494-2021
Ad-Tech Lightweight TECH ATTACH Cable…
- Product
- Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
- Quantity
- 10
- Codes and lots
- Item Code & Lot #: L-DCL-6DIN Lot # 121260; L-DCL-10DIN Lot #'s 124060 and 120340; L-DCL-16BDIN Lot # 120240.
- Recall started
- Aug. 9, 2021
- Device type
- Cable, Electrode
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-2495-2021
Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third…
- Product
- Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
- Quantity
- 8
- Codes and lots
- Item Code & Lot #: L-DC-10DIN Lot #'s 121240 and 126270.
- Recall started
- Aug. 9, 2021
- Device type
- Cable, Electrode
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-2496-2021
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2494-2021, Z-2495-2021, Z-2496-2021. The agency record governs; check it and the company before acting.