Ad-Tech TECH ATTACH Cable Recalled for Incorrect Label Information
Ad-Tech Medical recalled its Lightweight TECH ATTACH Cable due to incorrect labels on affected units. The cables are designed to connect electrodes to third-party monitors and stimulators.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a labeling error with no reported injuries or hospitalizations. The incorrect label version is a documentation issue rather than a defect in the product's function.
Plain-English summary
Ad-Tech Medical Instrument Corporation has recalled its Lightweight TECH ATTACH Cable due to incorrect version labels applied to the product. The cables are designed to connect electrodes to third-party patient monitors and stimulators.
Affected units include multiple product codes with the following lot numbers: L-DCL-6DIN Lot # 121260; L-DCL-10DIN Lot #'s 124060 and 120340; and L-DCL-16BDIN Lot # 120240. Worldwide distribution includes the United States (DC, FL, MI, NY, PA, TX), Spain, France, Italy, Greece, Great Britain, and Canada.
Consumers or healthcare facilities in possession of these cables should verify their product code and lot number against the recall notice. Contact Ad-Tech Medical Instrument Corporation with product details for guidance on replacement or proper identification.
The recalled product
- Product
- Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Item Code & Lot #: L-DCL-6DIN Lot # 121260
- L-DCL-10DIN Lot #'s 124060 and 120340
- L-DCL-16BDIN Lot # 120240.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ad-Tech Medical Instrument Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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