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Recall Observatory FDA recall evidence

Device product

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 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.

Z-0055-2015

September 16, 2014

Class II

Product summary

Firm
Bio-Detek, Inc.
Event
Event 69409
Status
Terminated
Classification
Class II
Quantity
41 singles
Official record key
device-enforcement:Z-0055-2015

Official wording

Reason: Product sterility is not assured

Code information: Lot Numbers: 1614, 1914, 2114

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility is not assured