Medtronic Infant Tubingset Recalled for Elevated Bacterial Endotoxin Levels
Medtronic is recalling 14 units of infant tubingsets due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (bacterial endotoxin) in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Perfusion Systems is recalling 14 units of the Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (Model M483203D). The recall is due to potentially elevated levels of bacterial endotoxin in the devices.
The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use medical device designed to collect and store blood during extracorporeal circulation. The primary blood-contacting surfaces are coated with Balance Biosurface to reduce platelet activation and adhesion. The affected lot numbers are 220781539 and 220887101.
Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. The devices were distributed worldwide, including in the United States and 23 other countries. Consumers and healthcare providers should stop using the affected devices and contact Medtronic Perfusion Systems for further instructions.
The recalled product
- Product
- Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy bl
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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