Edwards Lifesciences Fem-Flex II Arterial and femoral recall
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS…
Why was Edwards Lifesciences Fem-Flex II Arterial and femoral recalled?
Potential for separation of dilator tips.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 28,885
- Distribution
- Nationwide, including foreign, govt/VA/Military consignees.
- Recall date
- April 23, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)