The Recall Desk

FDA (Devices) recall action 69145

Bio-Detek, Inc. recalled 3 products on 2014-09-24

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.

Products
3
Announced
2014-09-24
Critical
0
Units
210

Why these products were recalled

Sterility of device is not assured

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.

1–3 of 3

  • HighFDA (Devices)··2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Concerns

    Bio-Detek is recalling 198 cases of ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ Nat
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues

    Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indicati
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues

    Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per Inte
    Category
    Distribution
    0 states