LivaNova SMART PERFUSION PACK INSPIRE 8S Recalled for Incorrect Cuvette Packaging
LivaNova USA Inc. is recalling 27 SMART PERFUSION PACK INSPIRE 8S units because they were packaged with the incorrect cuvette component.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging error involving the wrong component, with no reported injuries or illnesses.
Plain-English summary
LivaNova USA Inc. is recalling 27 units of the SMART PERFUSION PACK INSPIRE 8S. These products are perfusion tubing packs used in surgical procedures requiring extracorporeal support. The recall is due to a packaging error where the products were shipped with the incorrect cuvette component.
The affected products are identified by Model Number 046008200 and Lot Number 1912100141. The specific component involved is the Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette. The recall covers distribution in the state of Illinois.
Healthcare facilities and consumers should stop using the affected products and contact LivaNova USA Inc. for further instructions or a replacement.
The recalled product
- Product
- LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
- Manufacturer
- LivaNova USA Inc.
- Hazard
- Affected units
- 27
Distribution
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