The Recall Desk

FDA (Devices) recall action 61209

Covidien LLC dba Uni-Patch recalled 4 products on 2012-12-19

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2012-12-19
Critical
0
Units
37,036

Why these products were recalled

Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes 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.

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2012-12-19

    Voluntary Recall of Specific Lots of TENS Electrodes Due to Manufacturing Exposure

    Covidien is voluntarily recalling specific lots of TENS electrodes because wire surfaces may have been exposed to an employee with a minor cut during manufacturing.

    Product
    Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulati
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2012-12-19

    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.

    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.
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2012-12-19

    Voluntary Recall of Empi STIMC RE Self Adhesive Electrodes

    Covidien is voluntarily recalling specific lots of Empi STIMC RE Self Adhesive electrodes because manufacturing exposure to an employee with a minor cut may have occurred.

    Product
    Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand 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.
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2012-12-19

    Voluntary Recall of Specific Lots of Reusable TENS Electrodes

    Covidien is voluntarily recalling specific lots of reusable TENS electrodes because manufacturing process exposure to an employee with a minor cut may have occurred.

    Product
    Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardi
    Category
    Distribution
    5 states