Home / Recalls / Bio-Detek, Inc. / Z-2660-2014

Z-2660-2014 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
100 cases =600 units

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.

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-2658-2014 Class II — ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 T (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)