Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.
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 involving a sterile, prescription perfusion system with manufacturing defects (incomplete welds). Although no illnesses or injuries have been reported, it involves a risk-of-harm product used in critical medical procedures.
Plain-English summary
Medtronic Perfusion Systems is recalling the BB11J14R2 Bridge Custom Perfusion System tubing packs. The product is a sterile, prescription medical device used in perfusion support during cardiac procedures.
Specific lots were manufactured with insufficient or incomplete welds. The company initiated the recall because these manufacturing defects may affect the product's integrity.
The recall affects 15 tubing packs with lot numbers 22128923 (expiration date 2022-10-31) and 221815851 (expiration date 2023-01-18). These packs were distributed nationwide to healthcare facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.
Healthcare providers should review their inventory for the recalled lot numbers and contact Medtronic Perfusion Systems for additional information or replacement product.
The recalled product
- Product
- Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- incomplete-welds
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 20763000446516
- Lot numbers 22128923
- Use By 2022-10-31
- and Lot 221815851
- Use By 2023-01-18
Distribution
Distributed nationwide across the United States.
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