Device product
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Z-1945-2019
Product summary
- Firm
- Bio-Detek, Inc.
- Event
- Event 83040
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1789
- Official record key
device-enforcement:Z-1945-2019
Official wording
Reason: Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Code information: Lots 1719, 1719A, and 1819
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.
Derived failure modes
-
Unknown
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.