Home / Recalls / Bio-Detek, Inc. / Z-1945-2019

Z-1945-2019 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
July 10, 2019
Initiation Date
May 28, 2019
Termination Date
June 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1789

Product Description

ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

Reason for Recall

Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.

Distribution Pattern

Distributed to accounts in AZ, CA, CO, CT, FL, LA, MN, NV, OH, PA, TN, UT, and WY. International distribution to Canada, Germany, France, and Italy.

Code Information

Lots 1719, 1719A, and 1819

Other recalls by Bio-Detek, Inc.

  • Z-0053-2015 Class II — ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900 (September 16, 2014)
  • 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-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)
  • Z-2658-2014 Class II — ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 T (August 26, 2014)
  • Z-2565-2014 Class II — Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak D (March 12, 2013)