Bio-Detek, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2659-2014)

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 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.

Product Classification:

Class II

Date Initiated: August 26, 2014

Date Posted: September 24, 2014

Recall Number: Z-2659-2014

Event ID: 69145

Reason for Recall:

Sterility of device is not assured

Status: Terminated

Product Quantity: 12 each

Code Information:

Lot Number: 2314

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated