FDA (Devices) recall action 88590
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Incorrect version of labels were used.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ad-Tech Lightweight CABRIO Cables with incorrect labels are being recalled. Mislabeling could cause product misidentification affecting proper use in clinical monitoring applications.
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.
Ad-Tech Medical Instrument Corporation is recalling TECH ATTACH Cables due to incorrect labeling. The cables connect electrodes to third-party monitors and stimulators.