Voluntary Recall of Performa TENS Electrodes Due to Manufacturing Exposure
Covidien is voluntarily recalling specific lots of Performa TENS electrodes because wire surfaces may have been exposed to an employee with a minor cut during manufacturing.
What this means for you
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 a voluntary precautionary recall for a theoretical contamination risk (exposure to a minor cut) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Covidien LLC dba Uni-Patch is conducting a voluntary recall of specific lots of Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes. The recall involves 3,290 units from Lot 202406.
The recall was initiated because it was determined that during the manufacturing process, the surface of the wires in these lots may have been exposed to an employee who had a minor cut. This exposure occurred during the production of the cutaneous electrodes, which are applied directly to a patient's skin to apply electrical stimulation.
The affected products were distributed nationwide, including in California, Illinois, Massachusetts, Minnesota, and South Dakota. Consumers and healthcare providers should stop using the recalled electrodes and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
- Manufacturer
- Covidien LLC dba Uni-Patch
- Category
- Medical Device — Electrodes
- Hazard
- Affected units
- 3,290
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 (1)
- Lot 202406
Distribution
Part of a larger recall action
This product is one of 4 recalled by Covidien LLC dba Uni-Patch 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Covidien LLC dba Uni-Patch
See all →- ModerateVoluntary Recall of Specific Lots of TENS Electrodes Due to Manufacturing Exposure
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FDA (Devices) · 2012-12-19
- HighVoluntary Recall of Specific Lots of Reusable TENS Electrodes
FDA (Devices) · 2012-12-19
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