FDA Device recall Z-1945-2019
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) by Bio Detek, citing some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1945-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-28 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bio Detek |
| Distribution | AZ, CA, CO, CT, FL, LA, MN, NV, OH, PA, TN, UT, WY |
Product
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Reason
Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.
Identifiers
| code_info | Lots 1719, 1719A, and 1819 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1945-2019%22
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