| Class 2 Device Recall Edwards Lifesciences FemFlex II Arterial and femoral Cannulae with Duraflo coating | |
Date Initiated by Firm | April 09, 2014 |
Date Posted | April 16, 2014 |
Recall Status1 |
Terminated 3 on December 28, 2016 |
Recall Number | Z-1467-2014 |
Recall Event ID |
67983 |
510(K)Number | K123298 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Edwards Lifesciences, LLC 12050 Lone Peak Pkwy Draper UT 84020-9414
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For Additional Information Contact | SuzanneCarpenter 801-565-6100 |
Manufacturer Reason for Recall | Potential for separation of dilator tips. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Customers were notified via letter on 4/4/14 to return affected products. |
Quantity in Commerce | 28,885 |
Distribution | Nationwide, including foreign, govt/VA/Military consignees. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DWF
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