Home / Recalls / Bio-Detek, Inc. / Z-2565-2014

Z-2565-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
September 10, 2014
Initiation Date
March 12, 2013
Termination Date
June 17, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 cases (300 electordes)

Product Description

Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033

Reason for Recall

Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators

Distribution Pattern

Worldwide Distribution in Germany and Slovenia.

Code Information

Lot #0413 Expiration Date: 2015-01-26

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-0052-2015 Class II — ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 (September 16, 2014)
  • Z-0053-2015 Class II — ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900 (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-2660-2014 Class II — ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwire (August 26, 2014)