FDA-Device2014-04-23Class II
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.
Edwards Lifesciences, LLC
Hazard
Potential for separation of dilator tips.
Sold states
Nationwide, including foreign, govt/VA/Military consignees.
Affected count
28,885
Manufactured in
12050 Lone Peak Pkwy, N/A, Draper, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2014Don't want to check this manually?
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