FDAFDA · Food and drugs·Recall number Z-1466-2014
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.
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
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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