Edwards Lifesciences Recalls Duraflo Coated Femoral Cannula Due to Sealing Defect
Edwards Lifesciences is recalling 379 units of Duraflo coated Femoral Cannula because two unsealed pouches were found at a distribution location, posing a sterility risk.
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: The recall involves a risk-of-harm product (sterility breach) where injury has not yet been reported, aligning with the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Edwards Lifesciences, LLC is recalling 379 units of the Duraflo coated Femoral Cannula, Model DIIFEMII018A, Lot 59337174. The product is intended for rapid femoral venous and arterial access for short-term cardiopulmonary bypass. The recall was initiated after two unsealed pouches were discovered at an Edwards distribution location in Japan.
The unsealed pouches may result in a sterility barrier breach, which could compromise the safety of the medical device. The affected units were distributed nationwide in the United States, including the states of Florida, Massachusetts, Michigan, New York, Pennsylvania, and Texas.
Healthcare providers and facilities should stop using the affected cannulae and contact Edwards Lifesciences for further instructions on return or disposal. Consumers are not expected to have these devices in their homes, as they are intended for use in clinical settings.
The recalled product
- Product
- Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 379
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)
- Model DIIFEMII018A
- Lot 59337174
Distribution
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