Medtronic Custom Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic recalls custom perfusion system tubing packs due to potential manufacturing defects in welds. Specific lots may have insufficient or incomplete welds that could affect system integrity.
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 medical device recall for a manufacturing defect (weld quality) in surgical equipment. No illnesses or injuries have been reported. Per rubric criteria, Class II recalls score as High (3) when no hospitalization reports exist and the hazard remains theoretical.
Plain-English summary
Medtronic Perfusion Systems has recalled specific lots of its Custom Pack CB7J97R8 U14 E Sup Custom Perfusion System Sterile tubing packs. The recall was initiated because certain lots may have been manufactured with insufficient or incomplete welds.
The affected product was distributed nationwide to healthcare facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. Two specific lot numbers are subject to this recall: lot 220866440 (Use By 2022-07-10) and lot 221451579 (Use By 2022-10-24).
Healthcare providers should identify any affected tubing packs by their lot number and use-by date. Units with these lot numbers should be removed from service immediately. Facilities should contact Medtronic Perfusion Systems for additional information and guidance on this recall.
The recalled product
- Product
- Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- weld-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 (5)
- GTIN 00643169641228
- Lot numbers 220866440
- Use By 2022-07-10
- and 221451579
- Use By 2022-10-24
Distribution
Distributed nationwide across the United States.
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