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Recall Observatory FDA recall evidence

Device 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 International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

Z-2659-2014

August 26, 2014

Class II

Product summary

Firm
Bio-Detek, Inc.
Event
Event 69145
Status
Terminated
Classification
Class II
Quantity
12 each
Official record key
device-enforcement:Z-2659-2014

Official wording

Reason: Sterility of device is not assured

Code information: Lot Number: 2314

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterility of device is not assured