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Terminated

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.

FDA Recall Z-1466-2014 · Posted 2014-04-16

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDWF
Date Initiated2014-04-09
Date Terminated2016-12-28
Product Quantity13,115

Reason for Recall

Potential for separation of dilator tips.

Firm Action

Customers were notified via letter on 4/4/14 to return affected products.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide, including foreign, govt/VA/Military consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123298FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATINGEdwards Lifesciences, LLC · 2013-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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