Medtronic Cardiac Perfusion Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.
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 a Class II device recall involving a manufacturing defect in a critical component of cardiac surgery equipment. Although no injuries or deaths have been reported in the source text, incomplete welds in perfusion tubing present substantial risk in critical surgical applications.
Plain-English summary
Medtronic Perfusion Systems is recalling specific manufacturing lots of the BB8M63R5 Custom Pack Adult ECC (Extracorporeal Circulation) tubing packs. These are sterile, prescription medical device components used in custom perfusion systems during cardiac surgery.
The recall was issued because specific manufacturing lots may have been produced with insufficient or incomplete welds. Incomplete welds could affect the integrity and reliability of the tubing during use.
The affected lot number is 221249911, with a use-by date of October 22, 2022. The product was distributed nationwide to facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.
Healthcare providers who possess the affected tubing packs should discontinue use and contact Medtronic for instructions regarding replacement or return of the recalled inventory.
The recalled product
- Product
- Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- incomplete-welds
- 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 00763000458133
- Lot number 221249911
- Use By 2022-10-22
Distribution
Distributed nationwide across the United States.
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