West Chester, PA, United States
Therakos, Inc. recalls
1 recall recorded since 2018, most recently on 4 October 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 October 2021
- Reason
- Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
- Distribution
- IL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0212-2022
- THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
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.