FEM-FLEX II femoral arterial cannulas may have wire protruding from body
Edwards FEM-FLEX II Femoral Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 847 units affected.
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 recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The FEM-FLEX II Femoral Arterial Cannula, model number FEMII016AS, UDI 0060913168341, is being recalled. The cannula provides or establishes arterial perfusion. The action covers 847 units, comprising all lots up to BSLC1689.
The stated reason is complaints received for a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, including nationwide in the United States. The cannulas are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI and lot range above, quarantine it, and follow the instructions issued by Edwards.
The recalled product
- Product
- Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- protruding-wire
- cannula-defect
- perfusion
- class-i
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 (4)
- Lot Code: Model No
- FEMII016AS
- UDI: 0060913168341
- All lots up to: BSLC1689 Serial Numbers: FEMII016AS FEMII016AS FEMII016AS
Distribution
Distributed nationwide across the United States.
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