Medtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94965) due to potential sterile barrier breach. The cannula is used in cardiopulmonary bypass procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text states only a potential for sterile barrier breach with no reported injuries or illnesses. Per the rubric, Class II recalls without hospitalization reports are typically scored at 2 (Moderate).
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965, a cardiopulmonary bypass vascular catheter. The affected lot numbers are 0231665658 and C231786900 (GTIN 20643169454815). A total of 260 units have been distributed worldwide.
The product has the potential for a sterile barrier breach, which could compromise the sterile integrity of the device. The cannula is distributed in the United States and internationally to Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Healthcare facilities and providers in possession of affected lots should discontinue use and contact Medtronic Perfusion Systems for further guidance on this recall.
The recalled product
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- sterile-barrier-breach
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 20643169454815
- Lot Numbers: 0231665658
- C231786900.
Distribution
Distributed nationwide across the United States.