Pawtucket, RI, United States
Bio-Detek, Inc. recalls
1 recall recorded since 2018, most recently on 28 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 28 May 2019
- Terminated
- 1 June 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1945-2019
- ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.