Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects
Medtronic is recalling specific lots of HY10Z48R2 Adult ECC Custom Perfusion System tubing packs due to potential weld defects. Affected units may have insufficient or incomplete welds that could compromise device function.
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: This is an FDA Class II recall of a medical device with a confirmed manufacturing defect (insufficient or incomplete welds) in a life-critical application. However, the source reports no illnesses or injuries, placing it at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic is recalling specific lots of the HY10Z48R2 Adult ECC 1/4 Custom Perfusion System, a sterile prescription medical device. The recalled lot (#220866332) consists of 6 tubing packs with a use-by date of September 29, 2022.
These specific lots may have been manufactured with insufficient or incomplete welds, which could affect the structural integrity and proper function of the device.
The product was distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas, with no distribution to foreign, government, or military entities.
The recalled product
- Product
- Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- weld-defect
- structural-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN 00763000292034
- Lot #220866332
- Use By 2022-09-29
Distribution
Distributed nationwide across the United States.
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