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Edwards Lifesciences, LLC recalls Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 2
Recalled April 23, 2014 · FDA recall Z-1467-2014 · Edwards Lifesciences
Hazard
Potential for separation of dilator tips. · FDA Class II
Units
28,885
Sold at
Nationwide, including foreign, govt/VA/Military consignees.
Description
Potential for separation of dilator tips.
Product
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.
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →