Recall Z-2005-2021— Eight Medical International BV
Class I · Terminated
Class I FDA medical device recall by Eight Medical International BV, initiated 2021-06-04, terminated 2023-08-03. It names one FDA 510(k) clearance: K102900. Product: 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.. Reason: The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions..
- Recalling firm
- Eight Medical International BV
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-06-04
- Terminated
- 2023-08-03
- Firm location
- Bergen Op Zoom, N/A, Netherlands
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.