Z-2005-2021 Class I Terminated
FDA device recall Z-2005-2021 was initiated by Eight Medical International BV on June 4, 2021 and is designated Class I. Reason for recall: The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions. The recall status is terminated (terminated August 3, 2023). Affected quantity: 22.
Recall Details
- Product Type
- Devices
- Report Date
- August 4, 2021
- Initiation Date
- June 4, 2021
- Termination Date
- August 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22
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.
Distribution Pattern
US Nationwide, Colombia, and Dubai.
Code Information
UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686