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.
Reported: August 4, 2021 Initiated: June 4, 2021 #Z-2005-2021
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.
Details
- Recalling Firm
- Eight Medical International BV
- Units Affected
- 22
- Distribution
- US Nationwide, Colombia, and Dubai.
- Location
- Bergen Op Zoom, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Eight Medical International BV. Units affected: 22.
Why was this product recalled? ▼
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Critical. Recall number: Z-2005-2021.
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