Reported Apr 23, 2014 · Terminated
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 12050 Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.
- Lot codes and dates
105 of 105 codes
DFEMII016AS - 59036042592132985925840659578907DFEMII018AS - 5917612659249371592710035936952759374074594329375946846059484133595858545958994859645287 DFEMII020AS - 590360435911393559213299592584075932030859369528594329385946846159484119 DIIFEMII016A- 590251965906936859115263591345805915451959218668592408865924890659304339593422825938385359409789594534875947349159491809595237105952832459555055595899155962535959645284596517625968013359691448 DIIFEMII018A - 590302495906076459072416590939015911603759129577591496685917626259218745592409355924890759304334593371745935086559394866
- Amount recalled
- 28,885
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- VA
Why it was recalled
Potential for separation of dilator tips.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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