Medtronic Perfusion Tubing Packs Recalled for Low Ultrafiltration Performance
Medtronic is recalling specific perfusion tubing packs and hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Perfusion Systems is recalling specific lots of Medtronic Perfusion Tubing Packs and Hemocor High Performance Hemoconcentrators. The recall is due to the hemoconcentrators demonstrating low ultrafiltration performance that falls below product specifications.
The affected units were distributed worldwide, including nationwide in the United States and in several international countries. The total quantity involved is 1,594 units, with 1,306 distributed in the US and 288 outside the US. The products are used to manage a patient's hematocrit and fluid status during perfusion.
Healthcare facilities and users should stop using the affected lots and contact Medtronic Perfusion Systems for further instructions on replacement or return.
The recalled product
- Product
- MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9…
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
Distribution
Part of a larger recall action
This product is one of 2 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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