Ad-Tech Cueva Electrode Kits Recalled for Potential Wand Malfunction
Ad-Tech Medical Instrument Corporation is recalling Cueva Electrode Kits because the applicator wand may malfunction, potentially preventing monitoring of the VII cranial nerve.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential malfunction that could prevent monitoring of a cranial nerve, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling specific lots of 3 mm and 2 mm Cueva Electrode Kits. The recall involves 13 kits, which contain a total of 26 electrodes, 26 applicator wands, and 26 leadwires. The affected products are sterile, ethylene oxide (EO) sterilized, and labeled for prescription use only.
The recall was initiated due to concerns that the applicator wand may malfunction. This malfunction could potentially cause the inability to monitor the VII cranial nerve. The affected lots are identified by the following lot and batch numbers: Lot 208140447 (Batch 0060002), Lot 208140458 (Batch 0061723), and Lot 208140487R (Batch 0067938).
The products were distributed nationwide in the United States to the states of Colorado, Florida, Louisiana, New Jersey, Ohio, Washington, and Wisconsin, as well as internationally to Finland. Healthcare providers and consumers should check their inventory for these specific lot and batch numbers and stop using the affected kits if found.
The recalled product
- Product
- Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile E
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Category
- Medical Device — Electrode Kits
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)
- Lot number 208140447 Batch Number 0060002
- Lot Number 208140458 Batch Number 0061723
- LotNumber208140487R Batch Number 0067938.
Distribution
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