FDA recall Z-1945-2019

Bio-Detek, Inc. · Class II · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2019-05-28
Report date
2019-07-10
Termination date
2020-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pawtucket, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2019