Recirculator 8.0s Disposable Lavage Kit recalled for potential aluminum ion release
Eight Medical International BV is recalling the Recirculator 8.0s Disposable Lavage Kit due to potential aluminum ion release during warming therapy that may expose patients under certain use conditions.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This device received an FDA Class I regulatory classification, mandating a minimum severity of 4 per the rubric. Although the hazard is potential and no illnesses have been reported, the Class I classification ensures a Severe severity level.
Plain-English summary
The FDA has classified this recall of the Recirculator 8.0s Disposable Lavage Kit as Class I. The device is a hyperthermic perfusion system designed to raise the temperature of the thoracic or peritoneal cavity to a target temperature during medical procedures.
The recall concerns potential aluminum ion release that may occur during the warming therapy process under certain use conditions. This could expose patients to aluminum ions, which may pose a health risk depending on exposure levels and patient factors.
The manufacturer, Eight Medical International BV, is recalling 22 units of this device. The affected product has the code number 8100, GTIN 08719992086016, and includes the following lot numbers: 20021361, 20202106, 20018480, 19854186, 20019438, 19854185, 19854184, and 18687686. The device was distributed in the United States, Colombia, and Dubai.
Healthcare facilities and providers who have received this device should contact the manufacturer regarding return or replacement options. Patients or providers with questions should contact Eight Medical International BV for further guidance.
The recalled product
- 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.
- Manufacturer
- Eight Medical International BV
- Hazard
- Affected units
- 22
Distribution
Distributed nationwide across the United States.
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