Edwards FEMFLEXII Femoral Arterial Cannula Recalled for Exposed Protruding Wire
Edwards Lifesciences is recalling the FEMFLEXII Femoral Arterial Cannula due to complaints of a 3mm to 4mm section of wire protruding from the cannula body, posing a risk of injury.
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 Class I classification mandates a minimum severity score of 4. While complaints have been received regarding the hazard, there are no reported deaths or serious injuries documented in the source, therefore the recall is classified as Severe rather than Critical.
Plain-English summary
Edwards Lifesciences is recalling the FEMFLEXII Femoral Arterial Cannula, Model FEMII018AS, which is used to establish arterial perfusion in extracorporeal circuits. Approximately 558 units have been distributed worldwide, including across all United States and more than 40 countries.
The recall was initiated due to complaints received regarding a 3mm to 4mm section of wire that is exposed or protruding from the outside of the cannula body. This is a Class I FDA recall, indicating a serious safety concern.
The exposed wire poses a potential risk of injury during use or insertion. Facilities that have received this product should verify whether they possess affected units and contact Edwards Lifesciences for further guidance.
The recalled product
- Product
- Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- exposed-wire
- puncture-risk
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)
- Lot Code: Model No: FEMII018AS
- UDI: 00690103168358
- All lots up to: BSLC9064 Serial Numbers: 131776 BSLC4190 BSLC9064
Distribution
Distributed nationwide across the United States.
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