Medtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
Medtronic is recalling its Bio-Medicus Adult Cannula Kit (Product Number 96530-115) used in cardiopulmonary bypass procedures due to the discovery of loose foreign material containing trace levels of blood in two units.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class II recall. The product is a critical cardiopulmonary bypass device, and the presence of foreign material containing blood represents a significant contamination risk that could cause adverse health consequences during a life-sustaining procedure, meeting the Severe criterion.
Plain-English summary
Medtronic Perfusion Systems is recalling the Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115, a vascular cannula used in cardiopulmonary bypass procedures. The recall was initiated after the company received two complaints of loose foreign material that was confirmed to contain trace levels of blood.
This product was distributed nationwide in Maryland, California, Michigan, Washington, Pennsylvania, North Carolina, Florida, and Arkansas, as well as internationally. The affected lot number is 230257001 (UDI/DI 00643169769076).
Healthcare facilities and providers using this product should discontinue use of the affected lot and contact Medtronic for further instructions regarding replacement or safe disposition of the product. Patients who may have received treatment with an affected unit should consult with their healthcare provider.
The recalled product
- Product
- Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- foreign-material-contamination
- blood-contamination
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 (2)
- MATNR 00763000116019/UDI/DI 00643169769076
- Lot Number: 230257001
Distribution
Distributed nationwide across the United States.
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