Home / Recalls / Bio-Detek, Inc. / Z-2658-2014

Z-2658-2014 Class II Terminated

Recalled by Bio-Detek, Inc. — Pawtucket, RI

Recall Details

Product Type
Devices
Report Date
September 24, 2014
Initiation Date
August 26, 2014
Termination Date
May 3, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
198 cases

Product Description

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 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.

Reason for Recall

Sterility of device is not assured

Distribution Pattern

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

Code Information

Lot Number: 2314

Other recalls by Bio-Detek, Inc.

  • Z-1945-2019 Class II — ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8 (May 28, 2019)
  • Z-0054-2015 Class II — ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires (September 16, 2014)
  • Z-0055-2015 Class II — ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires (September 16, 2014)
  • Z-0053-2015 Class II — ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900 (September 16, 2014)
  • Z-0052-2015 Class II — ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 (September 16, 2014)
  • Z-2660-2014 Class II — ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwire (August 26, 2014)
  • Z-2659-2014 Class II — ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number (August 26, 2014)
  • Z-2565-2014 Class II — Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak D (March 12, 2013)