Recalls / —
—#126729
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.
- FDA product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K123298
- Affected lot / code info
- 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.
Why it was recalled
Potential for separation of dilator tips.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Customers were notified via letter on 4/4/14 to return affected products.
Recalling firm
- Firm
- Edwards Lifesciences, LLC
- Address
- 12050 Lone Peak Pkwy, Draper, Utah 84020-9414
Distribution
- Distribution pattern
- Nationwide, including foreign, govt/VA/Military consignees.
Timeline
- Recall initiated
- 2014-04-09
- Posted by FDA
- 2014-04-16
- Terminated
- 2016-12-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.