The Recall Desk

FDA (Devices) recall action 64248

ConMed Corporation recalled 2 products on 2013-02-27

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2013-02-27
Critical
0
Units
—

Why these products were recalled

Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Devices)··2013-02-27

    ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Seals

    ConMed is recalling specific lots of Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.

    Product
    ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Pouch Seals

    ConMed is recalling Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.

    Product
    ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
    Category
    Distribution
    0 states