Reported Apr 23, 2014 · Terminated
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models:…
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, arterial cannula sizes 16, 18 and 20 French
- models
FEMII016AFEMII016ASFEMII018AFEMII018ASFEMII020Aand FEMII020AS
- Lot codes and dates
184 of 184 codes
FEMII016A - 590281265904969659069370590771785909042259103195591240135913857959142234591513735917626559202398592114455921873959229566592321645924093259266788592768345931296659315604593422835936938859409771594444735946837759477867594994935950422259504265595094095955122759555094595638255956388159589947595899525960915459627646596305905963573659635737596518045966263059680124596801825968446959691508 FEMII016AS - 5904747859112421591830475922954159271782593948605946334559593794 FEMII018A - 590212435903535459043578590607615906076259062270
- Amount recalled
- 13,115
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.
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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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