Medtronic perfusion tubing packs recalled for manufacturing weld defects
Medtronic recalls 11 packs of HY10Y54R4 Custom Perfusion System tubing manufactured with insufficient or incomplete welds. No injuries have been reported.
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 Class II recall involves a manufacturing defect in critical medical tubing with potential for equipment failure during procedures. No illnesses or injuries have been reported, making the hazard theoretical rather than documented. Per the rubric, theoretical hazards without reported harm score at most 3.
Plain-English summary
Medtronic Perfusion Systems is recalling 11 tubing packs of the HY10Y54R4 Custom Pack ECC PED 1/4 Custom Perfusion System. The product is used for extracorporeal circulation procedures.
Specific lots may have been manufactured with insufficient or incomplete welds. This manufacturing defect could affect the integrity and reliability of the tubing during medical procedures.
The affected product was distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The recall involves Lot number 221387881 with a Use By date of October 21, 2022.
Patients and healthcare providers should contact Medtronic immediately if they have concerns about whether they possess affected product. No injuries or illnesses have been reported to date.
The recalled product
- Product
- Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- weld-defect
- manufacturing-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 00763000306717
- Lot number 221387881
- Use By 2022-10-21
Distribution
Distributed nationwide across the United States.
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