Bio-Detek, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2660-2014)

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 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 indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

Product Classification:

Class II

Date Initiated: August 26, 2014

Date Posted: September 24, 2014

Recall Number: Z-2660-2014

Event ID: 69145

Reason for Recall:

Sterility of device is not assured

Status: Terminated

Product Quantity: 100 cases =600 units

Code Information:

Lot Number: 2314

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated