Medtronic Perfusion Tubing Packs Recalled Due to Cuvette Safety Alert
Medtronic is recalling specific lots of Perfusion Tubing Packs because they contain Terumo CVS cuvettes subject to an Urgent Safety Alert.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Perfusion Systems is notifying customers about specific lots of Medtronic Custom Perfusion Tubing Packs, Rx, Sterile EO. These packs are being recalled because they contain CD I¿ H/S Cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS), which are the subject of an Urgent Safety Alert. The cuvette is packaged into the Medtronic Perfusion Tubing Packs and is only sold as part of the pack.
The product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures. A total of 9,890 units are affected, with 7,773 distributed in the US and 2,117 distributed outside the US. The recall covers distribution in numerous US states and internationally to countries including Australia, Belgium, Canada, and Germany.
Customers who have or may receive these specific lots should stop using the affected products and contact Medtronic for further instructions. The recall is limited to the specific catalog numbers and lot numbers listed in the official FDA record.
The recalled product
- Product
- Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This pro
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Cardiovascular
- Hazard
Distribution
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