FDA recall Z-2005-2021

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 for recall

The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.

Distribution

US Nationwide, Colombia, and Dubai.

Key facts

Status

Terminated

Initiation date

2021-06-04

Report date

2021-08-04

Termination date

2023-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bergen Op Zoom, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2005-2021