Bergen Op Zoom, N/A, Netherlands
Eight Medical International BV recalls
1 recall recorded since 2018, most recently on 4 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 4 June 2021
- Terminated
- 3 August 2023
- Reason
- The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
- Distribution
- US Nationwide, Colombia, and Dubai.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2005-2021
- Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
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.