Home / Recalls / Bio-Detek, Inc. / Z-0052-2015

Z-0052-2015 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 15, 2014
Initiation Date
September 16, 2014
Termination Date
May 3, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
237 cases (6/case)

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.

Reason for Recall

Product sterility is not assured

Distribution Pattern

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

Code Information

Lot Numbers: 1614, 1814, 1914

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-2660-2014 Class II — ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwire (August 26, 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)