FDA-Device2014-04-23Class II
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
Edwards Lifesciences, LLC
Hazard
Potential for separation of dilator tips.
Sold states
Nationwide, including foreign, govt/VA/Military consignees.
Affected count
13,115
Manufactured in
12050 Lone Peak Pkwy, N/A, Draper, UT, United States
Products
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1466-2014Don't want to check this manually?
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