Stryker Sustainability Solutions recalls CS Uni-Directional w Auto ID, Product Number D135304; REPROC
See all recalls from Stryker Sustainability Solutions →Recalled Product
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard / Issue
Incomplete seals on sterile product
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI 07613327357318, Lot Numbers: 3351120, 4756053, 4820613, 4880639, 4937971, 4953195, 4974710, 5002528, 5033775, 5067727, 3351123, 4761288, 4821747, 4880648, 4937973, 4953196, 4975470, 5002529, 5033776, 5069585, 3352961, 4764911, 4821750, 4880654, 4937974, 4953197, 4975472, 5002530, 5034566, 5069588, 3369921, 4766954, 4822911, 4880655, 4937975, 4953198, 4975598, 5002531, 5034567, 5069594, 3369925, 4766956, 4824997, 4880656, 4937976, 4953200, 4977751, 5002855, 5034568, 5069597, 3369927, 4767155, 4825261, 4880657, 4937977, 4953201, 4977753, 5003960, 5034569, 5069599, 3369928, 4772390, 4825262, 4880658, 4937982, 4953202, 4977754, 5004190, 5034570, 5069603, 3425440, 4775105, 4825572, 4880938, 4937983, 4953203, 4977768, 5004192, 5034571, 5069606, 3443600, 4786470, 4825573, 4882690, 4937988, 4953204, 4977769, 5004217, 5034572, 5069609, 3444721, 4793099, 4825574, 4882691, 4937992, 4953205, 4977771, 5004219, 5034573, 5071436, 3446184, 4793102, 4825577, 4882693, 4937996, 4953206, 4977773, 5004221, 5034655, 5072106, 3476984, 4793119, 4825814, 4882694, 4938440, 4953338, 4980428, 5005557, 5034903, 5072107, 3485190, 4794754, 4826925, 4882695, 4938441, 4953339, 4980840, 5005558, 5037952, 5072206, 3485192, 4794914, 4826926, 4883802, 4938442, 4953340, 4980841, 5005932, 5037953, 5072407, 3610789, 4795026, 4826927, 4883812, 4940663, 4953341, 4980842, 5005933, 5038342, 5072408, 3662960, 4796837, 4826928, 4883949, 4940850, 4953342, 4980843, 5012759, 5038392, 5072409, 3689125, 4796969, 4826929, 4883950, 4940851, 4953343, 4980844, 5012977, 5038393, 5072410, 3689126, 4797346, 4826930, 4883951, 4941131, 4953344, 4980873, 5014498, 5038394, 5072411, 3697347, 4797347, 4827995, 4883952, 4941133, 4953345, 4980874, 5017458, 5040937, 5072412, 3697352, 4797348, 4827997, 4883953, 4941138, 4955023, 4980875, 5017459, 5040938, 5073110, 3703895, 4797349, 4828183, 4883954, 4941163, 4955024, 4980876, 5017460, 5040939, 5073111, 3703898, 4797351, 4829479, 4890927, 4941164, 4955025, 4980877, 5017461, 5043130, 5073112, 3703899, 4797353, 4830599, 4890957, 4941165, 4960181, 4980878, 5017530, 5043131, 5073113, 3715609, 4797354, 4830791, 4890959, 4941166, 4960193, 4980879, 5017531, 5043134, 5076106, 3715640, 4797356, 4830793, 4890972, 4941167, 4960201, 4980880, 5017532, 5043135, 5076108, 3729296, 4797358, 4830794, 4891905, 4941168, 4960210, 4983266, 5017535, 5043372, 5076109, 3729298, 4797359, 4830991, 4891906, 4941169, 4960224, 4983270, 5017537, 5043681, 5076111, 3976771, 4797363, 4831021, 4891907, 4941170, 4960226, 4983272, 5017538, 5043944, 5076112, 3979774, 4797364, 4833203, 4891908, 4941175, 4960620, 4983284, 5017542, 5044078, 5076115, 4020150, 4797365, 4837752, 4891909, 4941951, 4960725, 4984093, 5019519, 5044079, 5076118, 4022512, 4797876, 4837754, 4891910, 4941953, 4960726, 4984094, 5019520, 5044082, 5076120, 4050955, 4797889, 4837843, 4891911, 4941954, 4960727, 4984097, 5019522, 5044083, 5076121, 4086384, 4798288, 4838883, 4891912, 4941955, 4960728, 4984302, 5019566, 5044084, 5076126, 4086387, 4799276, 4840238, 4891913, 4947436, 4960729, 4985812, 5021631, 5044087, 5076127, 4481221, 4799821, 4841966, 4891914, 4947437, 4961610, 4985815, 5021781, 5044203, 5076128, 4614498, 4800185, 4842013, 4892202, 4947439, 4961611, 4985821, 5021782, 5044204, 5076129, 4614502, 4800186, 4844645, 4896329, 4947440, 4961612, 4985823, 5021819, 5044206, 5076130, 4649179, 4800188, 4845486, 4896330, 4947441, 4961613, 4985824, 5021820, 5044253, 5076131, 4650571, 4800193, 4845490, 4896331, 4947443, 4961614, 4986557, 5021821, 5044261, 5076134, 4663387, 4800194, 4845491, 4896332, 4950355, 4961615, 4987036, 5023691, 5044420, 5082198, 4668855, 4800195, 4847650, 4896333, 4950356, 4961616, 4987393, 5023946, 5044421, 5082202, 4673972, 4800198, 4849977, 4896334, 4950549, 4961617, 4987587, 5025606, 5045183, 5082205, 4726087, 4800199, 4850105, 4896419, 4950553, 4962190, 4990610, 5025607, 5045185, 5082207, 4726095, 4800200, 4850107, 4896421, 4953131, 4962191, 4990820, 5025608, 5045186, 5082209, 4726096, 4800204, 4853343, 4896422, 4953133, 4962981, 4990821, 5025724, 5045891, 5082211, 4726103, 4800206, 4854412, 4896423, 4953134, 4962982, 4990822, 5025725, 5052613, 5082212, 4726780, 4800279, 4855363, 4896424, 4953136, 4963015, 4992270, 5025727, 5052614, 5082213, 4728807, 4800874, 4855364, 4897428, 4953137, 4963016, 4993094, 5025728, 5052615, 5082214, 4728839, 4800876, 4855367, 4937750, 4953138, 4963017, 4993095, 5025729, 5053557, 5082215, 4729213, 4800877, 4855666, 4937754, 4953139, 4963040, 4993096, 5025895, 5053558, 5082216, 4730622, 4801737, 4856278, 4937757, 4953140, 4963308, 4993111, 5025912, 5053559, 5082217, 4730634, 4801959, 4859383, 4937759, 4953142, 4963309, 4993119, 5025919, 5053560, 5082218, 4731318, 4802512, 4859384, 4937760, 4953144, 4963310, 4993226, 5026193, 5053561, 5083460, 4731328, 4802614, 4859413, 4937763, 4953145, 4966247, 4993227, 5026194, 5054082, 5085972, 4732001, 4802815, 4859417, 4937769, 4953146, 4966248, 4993228, 5026692, 5056201, 5085973, 4733531, 4802925, 4859709, 4937836, 4953147, 4968799, 4994012, 5026693, 5056202, 5086369, 4734479, 4803529, 4860609, 4937837, 4953148, 4972869, 4994080, 5026832, 5056203, 5086371, 4735289, 4803533, 4861443, 4937838, 4953169, 4972872, 4994803, 5029136, 5056848, 5086372, 4736363, 4803808, 4864439, 4937839, 4953171, 4973398, 4994860, 5029137, 5057349, 5086373, 4737394, 4804041, 4864848, 4937840, 4953173, 4973417, 4994863, 5032245, 5058020, 5086374, 4738377, 4806961, 4864851, 4937841, 4953176, 4973418, 4994866, 5032246, 5058021, 5086376, 4738390, 4807448, 4864875, 4937847, 4953177, 4973421, 4998169, 5033410, 5059047, 5086377, 4738391, 4807605, 4864876, 4937848, 4953178, 4973426, 4998170, 5033412, 5059077, 5086379, 4738395, 4807717, 4864877, 4937851, 4953179, 4973427, 4998947, 5033591, 5059078, 5086380, 4739012, 4807718, 4867552, 4937854, 4953180, 4973430, 4998948, 5033619, 5061477, 5086521, 4741793, 4814727, 4867805, 4937855, 4953185, 4973463, 4998950, 5033620, 5061478, 5086522, 4741794, 4818092, 4868856, 4937856, 4953186, 4973465, 4998951, 5033621, 5061479, 5086523, 4749251, 4818093, 4869232, 4937857, 4953188, 4973466, 4998952, 5033622, 5061480, 5086525, 4749265, 4818095, 4870634, 4937858, 4953190, 4973468, 4998953, 5033623, 5061481, 5086526, 4749373, 4818194, 4876110, 4937859, 4953191, 4973470, 4999004, 5033624, 5062616, 5086539, 4749406, 4820176, 4877011, 4937863, 4953192, 4973476, 4999893, 5033625, 5062617, 5086666, 4749796, 4820610, 4880527, 4937865, 4953193, 4973858, 5002388, 5033773, 5062618, 5086667, 4755379, 4820611, 4880638, 4937868, 4953194, 4974111, 5002527, 5033774, 5066983.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for CS Uni-Directional w Auto →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime