FDAFDA · Food and drugs·Recall number Z-1467-2014
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.
Published April 23, 2014 · Recall initiated: April 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for separation of dilator tips.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- Nationwide, including foreign, govt/VA/Military consignees.
- Lot
- DFEMII016AS - 59036042, 59213298, 59258406, 59578907; DFEMII018AS - 59176126, 59249371, 59271003, 59369527, 59374074, 59432937, 59468460, 59484133, 59585854, 59589948, 59645287 DFEMII020AS - 59036043, 59113935, 59213299, 59258407, 59320308, 59369528, 59432938, 59468461, 59484119 DIIFEMII016A- 59025196, 59069368, 59115263, 59134580, 59154519, 59218668, 59240886, 59248906, 59304339, 59342282, 59383853, 59409789, 59453487, 59473491, 59491809, 59523710, 59528324, 59555055, 59589915, 59625359, 59645284, 59651762, 59680133, 59691448 DIIFEMII018A - 59030249, 59060764, 59072416, 59093901, 59116037, 59129577, 59149668, 59176262, 59218745, 59240935, 59248907, 59304334, 59337174, 59350865, 59394866, 59431915, 59468375, 59493314, 59528325, 59555040, 59577156, 59599140, 59609142, 59625362, 59651760, 59651808, 59680241 DIIFEMII020A - 59043574, 59069369, 59082560, 59103193, 59124011, 59134578, 59149667, 59176263, 59191993, 59218735, 59229561, 59240934, 59266786, 59299945, 59318926, 59319458, 59337178, 59350871, 59404487, 59437572, 59473387, 59484151, 59516163, 59531221, 59558959, 59563837, 59585992, 59609143, 59620175, 59642447, 59651767, 59651823, 59662388, 59680247.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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