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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description 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.
Recall Number Z-1466-2014
Classification Class II
Code Info FEMII016A - 59028126, 59049696, 59069370, 59077178, 59090422, 59103195, 59124013, 59138579, 59142234, 59151373, 59176265, 59202398, 59211445, 59218739, 59229566, 59232164, 59240932, 59266788, 59276834, 59312966, 59315604, 59342283, 59369388, 59409771, 59444473, 59468377, 59477867, 59499493, 59504222, 59504265, 59509409, 59551227, 59555094, 59563825, 59563881, 59589947, 59589952, 59609154, 59627646, 59630590, 59635736, 59635737, 59651804, 59662630, 59680124, 59680182, 59684469, 59691508 FEMII016AS - 59047478, 59112421, 59183047, 59229541, 59271782, 59394860, 59463345, 59593794 FEMII018A - 59021243, 59035354, 59043578, 59060761, 59060762, 59062270, 59064759, 59070872, 59079659, 59081681, 59082564, 59092366, 59093899, 59107280, 59114713, 59118388, 59124014, 59126280, 59138577, 59142229, 59142233, 59149665, 59169476, 59173958, 59173973, 59191995, 59210228, 59211444, 59211451, 59218738, 59222629, 59229567, 59235556, 59235558, 59254373, 59261612, 59271772, 59274361, 59299840, 59304350, 59304353, 59315607, 59332980, 59350864, 59379048, 59383856, 59400071, 59437566, 59437567, 59448621, 59458038, 59468821, 59477813, 59477838, 59490065, 59509300, 59509407, 59516176, 59528326, 59546034, 59551226, 59555043, 59555095, 59568507, 59577160, 59581459, 59585855, 59593828, 59604721, 59604722, 59604768, 59615024, 59616140, 59634860, 59634914, 59640034, 59640111, 59645315, 59648786, 59651807, 59651818, 59651905, 59680127, 59680192, 59684473, 59691468, 59691497 FEMII018AS- 59442433, 59551221, 59662385, 59684809 FEMII020A - 59442434, 59444471, 59458044, 59473388, 59477822, 59484137, 59492047, 59509404, 59514153, 59518778, 59523721, 59528327, 59528328, 59551224, 59555098, 59558960, 59572973, 59581458, 59581565, 59585993, 59593791, 59593830, 59599145, 59599177, 59615023, 59616141, 59620333, 59640098, 59641413, 59641415, 59648784, 59651907, 59651909, 59662631, 59670296, 59680176, 59691467, 59702375, FEMII020AS - 59473385, 59555025, 59675123.
Product Distributed Qty 13,115
Reason For Recall Potential for separation of dilator tips.

Event Detail

Event Id 67983
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Draper
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, including foreign, govt/VA/Military consignees.
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