Z-1945-2019 Class II Terminated
FDA device recall Z-1945-2019 was initiated by Bio-Detek, Inc. on May 28, 2019 and is designated Class II. Reason for recall: Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy. The recall status is terminated (terminated June 1, 2020). Affected quantity: 1789.
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