Z-2495-2021Class II
Ad-Tech Lightweight TECH ATTACH Cable -
AD-Tech Medical Instrument Corp. / initiated 2021-08-09 / Terminated / root cause: labeling and UDI
Ad-Tech Medical Instrument Corporation began a recall of Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators on . FDA classified it as Class II and gives the reason as "Incorrect version of labels were used". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2495-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- AD-Tech Medical Instrument Corp.
- Product
- Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
- Product code
- IKD Cable, Electrode
- Reason for recall
- Incorrect version of labels were used.
- Root cause tag
- labeling and UDI
- FDA root cause
- 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 [email protected]; FAX: 262-634-5668 or Telephone 800-776-1555. For questions contact Ad-Tech Clinical Specialist.
- Quantity in commerce
- 10
- 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.
- Product codes and lots
- Item Code & Lot #: L-DCL-6DIN Lot # 121260; L-DCL-10DIN Lot #'s 124060 and 120340; L-DCL-16BDIN Lot # 120240.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2494-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2495-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2496-2021 | Class II | Terminated | Voluntary: Firm initiated |
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