FDA-Device2019-07-10Class II
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Bio-Detek, Inc.
Hazard
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Sold states
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.
Affected count
1789
Manufactured in
525 Narragansett Park Dr, N/A, Pawtucket, RI, United States
Products
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2019Don't want to check this manually?
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