Bio-Detek, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0052-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 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.

Product Classification:

Class II

Date Initiated: September 16, 2014

Date Posted: October 15, 2014

Recall Number: Z-0052-2015

Event ID: 69409

Reason for Recall:

Product sterility is not assured

Status: Terminated

Product Quantity: 237 cases (6/case)

Code Information:

Lot Numbers: 1614, 1814, 1914

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated