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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Navilyst Medical, Inc: The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.; The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit,

Agency Publication Date: February 26, 2015
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Affected Products

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONLY For single use only. ---Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4476878, 4638166, 4677141.

Product: NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, STERILE, Rx ONLY --- For single use only. Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4292208, 4359084, 4443792, 4579969, 4653007, 4677167, 4722480, 4748791, 4756087, 4783647, 4794937, 4814881, 4827683.

Product: NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4336772, 4425567, 4446897, 4501937, 4504897, 4643824, 4673067, 4692594, 4704379, 4712690, 4732852, 4788579.

Product: NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY --- For single use only. Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4364622 and 4376537.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4244449, 4251616, 4271341, 4298367, 4332985, 4344419, 4384598, 4406798, 4419284, 4435205, 4444068, 4446990, 4474943, 4499774, 4505446, 4547470, 4572866, 4572867, 4604183, 4612902, 4623277, 4623278, 4638284, 4643168, 4650003, 4650787, 4662092, 4662093, 4666759, 4669330, 4675594, 4689567, 4697147, 4706860, 4709912, 4713117, 4718988, 4721364, 4727236, 4741949, 4748140, 4751102, 4760883, 4768588, 4779430, 4788780, 4798082, 4821320, 4824164.

Product: NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4244953, 4269320, 4384561, 4394016, 4416958, 4437380, 4442476, 4447489, 4475748, 4504884, 4508759, 4535420, 4603968, 4612720, 4622798, 4623909, 4641674, 4641675, 4654862, 4662506, 4666610, 4672626, 4672627, 4690446, 4697032.

Product: NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, STERILE, Rx ONLY --- --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4606270, 4612210, 4616194, 4617867, 4623170, 4641411, 4649602, 4653594, 4655245, 4661836, 4663939, 4665119, 4666347, 4671948, 4672567, 4680203, 4690158, 4690850, 4701000, 4704036, 4704366, 4712691, 4717116, 4719844, 4729019, 4729020, 4771553, 4780273, 4797512, 4805753, 4809347, 4821812, 4831367.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4281038, 4309507, 4316974, 4345324, 4391599, 4394037, 4413639, 4437396, 4445586, 4462921, 4487772, 4491909, 4535424, 4573282, 4604031, 4611496, 4612705, 4621526, 4637682, 4641685, 4642795, 4649887, 4655637, 4662091, 4666229, 4673307, 4673972, 4680960, 4685521, 4689891, 4691475, 4696324, 4696697, 4704058, 4707554, 4709840, 4715431, 4719309, 4723227, 4729582, 4735756, 4743050, 4751064, 4761328, 4764903, 4770755, 4785895, 4811466, 4814714, 4817065, 4821059, 4826601, 4832365.

Product: NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4581678, 4588087, 4595774, 4597572, 4620890, 4623072, 4638352, 4638441, 4638716, 4649828, 4666871, 4667422, 4672695, 4673930, 4675943, 4682904, 4683074, 4690302, 4691995, 4696832, 4697871, 4705245, 4706280, 4712876, 4716291, 4719214, 4723095, 4726325, 4732488, 4736759, 4741819, 4747942, 4750563, 4754213, 4758421, 4764526, 4770835, 4770836, 4779369, 4786420, 4786852, 4788678, 4793428, 4798011, 4798852, 4807360, 4810742, 4816060, 4822700, 4825124, 4832744.

Product: NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4346227, 4510688, 4644193, 4692124, 4694166.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4247589, 4269253, 4271313, 4310122, 4342473, 4344822, 4387486, 4388838, 4414801, 4419289, 4437439, 4447579, 4474969, 4491873, 4504923, 4534887, 4534888, 4572805, 4604160, 4612239, 4624081, 4640706, 4641690, 4649150, 4651400, 4655126, 4660971, 4662034, 4666092, 4672688, 4680286, 4682905, 4690303, 4697126, 4697804, 4705250, 4708240, 4712693, 4721403, 4731034, 4742373, 4799479, 4807935, 4810688, 4814038, 4814614.

Product: NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4239391, 4243486, 4248969, 4253169, 4260193, 4268148, 4279179, 4288388, 4298216, 4306873, 4315493, 4322272, 4330719, 4338372, 4342371, 4346174, 4355672, 4362474, 4372470, 4384182, 4393676, 4398975, 4403978, 4413500, 4423296, 4427571, 4438026, 4439842, 4441465, 4442714, 4448567, 4456976, 4466287, 4469567, 4476873, 4485284, 4492411, 4499668, 4501959, 4515770, 4547972, 4556175, 4561968, 4566668.

Product: NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4226931, 4244899, 4269158, 4269159, 4279292, 4309494, 4316972, 4326577, 4344275, 4384465, 4398606, 4413579, 4413580, 4436613, 4436614, 4447485, 4447486, 4475711, 4481532, 4485378, 4504902, 4534825, 4538802, 4541779, 4562374, 4573281, 4576428, 4604027, 4612707, 4613696, 4618770, 4623907, 4641061, 4641095, 4641232, 4644756, 4647588, 4649176, 4655804, 4656639, 4656988, 4661636, 4663481, 4666154, 4672735, 4672736, 4680531, 4687102, 4689667, 4691427, 4692343, 4696543, 4705363, 4705364, 4708056, 4716479, 4718977, 4726269, 4729463, 4735799, 4737032, 4742482, 4748222, 4749886, 4749887, 4754418, 4764644, 4764645, 4771338, 4771339, 4772875, 4779717, 4779718, 4786227, 4789772, 4798118, 4798119, 4799295, 4807444, 4812343, 4814045, 4814641, 4816928, 4824220, 4825187, 4829965, 4831744, 4832332.

Product: NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4264475, 4296977, 4344401, 4413661, 4648657, 4673931, 4697105, 4701908, 4723134, 4750810, 4788731.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4246299, 4271288, 4279323, 4309482, 4336779, 4346494, 4365250, 4377114, 4384505, 4399088, 4413662, 4419628, 4437368, 4447518, 4462779, 4487773, 4498391, 4504948, 4535392, 4578775, 4604029, 4610090, 4612650, 4613699, 4623934, 4641236, 4642401, 4650062, 4654891, 4661653, 4666169, 4672802, 4680503, 4682822, 4687557, 4689653, 4697195, 4706129, 4706617, 4708156, 4718975, 4722867, 4729466, 4737452, 4742079, 4750934, 4760422, 4771607, 4774667, 4785145, 4790579, 4796276, 4804741, 4808877, 4811375, 4811376.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4393719, 4617238, 4717511.

Product: NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4249077, 4269176, 4279293, 4309514, 4344291, 4357820, 4374582, 4397278, 4408802, 4413652, 4417802, 4437356, 4446935, 4448734, 4475767, 4505455, 4508682, 4534876, 4549032, 4573232, 4603970, 4612729, 4613703, 4623930, 4640696, 4641242, 4650060, 4650061, 4654980, 4662133, 4665914, 4672429, 4672430, 4680371, 4682826, 4690910, 4691429, 4696900, 4704415, 4712996, 4722861, 4730922, 4735734, 4742076, 4742077, 4751114, 4764646, 4771431, 4780605, 4786234, 4798124, 4808876, 4812348, 4814046, 4819811, 4831349.

Product: NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE, Rx ONLY ---For single use only. ---Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4268419, 4310080, 4344788, 4393891, 4416012, 4462784, 4535382, 4575640, 4608478, 4624082, 4641213, 4666593, 4680409, 4689497, 4696721, 4707605, 4730974, 4742627, 4759572, 4772627, 4782953, 4793007, 4793974, 4824273.

Product: NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4361877, 4362670, 4384555, 4475742, 4534905, 4534906, 4572742, 4573424, 4603617, 4613738, 4623233, 4641655, 4642470, 4649930, 4654858, 4662098, 4666862, 4667793, 4672390, 4680972, 4681793, 4690126, 4696307, 4702956, 4706317, 4716358, 4726251, 4736913, 4747725, 4766391, 4778794, 4816062, 4820335, 4824146, 4834213.

Product: NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4268921, 4310402, 4317001, 4384580, 4442479, 4500790, 4504919, 4599070, 4645482, 4661978, 4680493, 4704381, 4742117, 4777180, 4801317.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 60111311, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4426312, 4708385, 4799474.

Product: NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4249145, 4254175, 4268512, 4284473, 4310130, 4344873, 4384704, 4397287, 4413719, 4416032, 4436682, 4438637, 4447642, 4447643, 4448692, 4474988, 4477699, 4504970, 4507585, 4548216, 4576444, 4604159, 4612896, 4623259, 4641644, 4642461, 4649980, 4651109, 4654675, 4657004, 4662482, 4666766, 4667313, 4674583, 4675364, 4681741, 4684814, 4690123, 4690865, 4696794, 4697801, 4708269, 4714213, 4719437, 4722836, 4728731, 4742374, 4751087, 4764365, 4771000, 4779457, 4780513, 4790678, 4797308, 4798878, 4809191, 4816855, 4829925.

Product: NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4245021, 4260368, 4268542, 4279333, 4309640, 4344841, 4380268, 4387481, 4390493, 4413788, 4436076, 4436659, 4447611, 4474955, 4491914, 4503486, 4505497, 4534914, 4549037, 4573406, 4576438, 4603643, 4708214, 4714177, 4716348, 4726245, 4729318, 4734982, 4750219, 4750566, 4760725, 4766447, 4779497, 4780532, 4790816, 4802163, 4811301, 4819730, 4822657.

Product: NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4244489, 4271338, 4309646, 4344388, 4384655, 4413797, 4436666, 4447014, 4474968, 4504993, 4534943, 4573410, 4603649, 4612909, 4623298, 4641672, 4649950, 4655315, 4662089, 4666877, 4681114, 4681115, 4696787, 4705270, 4722833, 4736920, 4750582, 4775916, 4788807, 4812781.

Product: NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4426279, 4500022, 4519371, 4637654, 4651033.

Product: NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4245041, 4252386, 4264488, 4268495, 4309476, 4345299, 4348476, 4380280, 4394034, 4419651, 4436717, 4447629, 4462923, 4475805, 4505511, 4535484, 4562284, 4573288, 4603997, 4612732, 4614157, 4623931, 4640168, 4648179, 4649858, 4655616, 4661388, 4662524, 4665312, 4675131, 4676801, 4680698, 4681640, 4690188, 4697403, 4704635, 4709841, 4719502, 4728772, 4730802, 4732490, 4742134, 4751285, 4751286, 4764246, 4771396, 4786638, 4790837, 4798283, 4807655, 4817054, 4825292.

Product: NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4500974

Lot Numbers:
4500974
Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4663410 and 4664414.

Product: NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4271315, 4310125, 4604147, 4655162, 4706282, 4745859, 4788727.

Product: NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4244996, 4268514, 4309652, 4344899, 4384715, 4413714, 4416475, 4427869, 4436687, 4446940, 4462788, 4475813, 4497183, 4505444, 4535487, 4573413, 4596269, 4603652, 4612242, 4623263, 4641708, 4648693, 4655459, 4662534, 4666069, 4673336, 4675495, 4681101, 4687284, 4689557, 4692644, 4696309, 4696839, 4701646, 4705231, 4714202, 4721733, 4730794, 4732723, 4742060, 4750914, 4750915, 4758132, 4771075, 4777077, 4788097, 4789067, 4794638, 4798923, 4804759, 4817044, 4821811.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4608719

Lot Numbers:
4608719
Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4252270, 4258403, 4267307, 4286293, 4296386, 4305398, 4312787, 4319281, 4336401, 4343385, 4352284, 4370385, 4417683, 4427096, 4436520, 4439649, 4445172, 4455645, 4469281, 4474769, 4483300, 4491492, 4501007, 4504388, 4526037, 4534521, 4548004, 4556186, 4563246, 4572198, 4579885, 4589493, 4596981, 4602977, 4610952, 4615163, 4635832, 4640945, 4641157, 4643773, 4644633, 4645742, 4647216, 4651057, 4652077, 4653026, 4654115, 4656506, 4659419, 4661293, 4666038, 4669620, 4672305, 4675911, 4677125, 4678565, 4680094, 4683383, 4687490, 4691906, 4699478, 4701150, 4705865, 4707039, 4713618, 4717093, 4721008, 4721703, 4728322, 4734590, 4737996, 4747095, 4752736, 4755523, 4758049, 4761399, 4769406, 4773514, 4775480, 4778540, 4782788, 4789727, 4792459, 4792513, 4794949, 4799221, 4800287, 4805516, 4808480, 4811203, 4813943, 4820909, 4829858, 4832192, 4833848, 4834156.

Product: NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4245006, 4268525, 4288675, 4298374, 4309604, 4316993, 4344871, 4346516, 4384630, 4390477, 4399101, 4399572, 4413766, 4416028, 4427115, 4435172, 4447598, 4475830, 4501873, 4505482, 4517175, 4528809, 4535495, 4572819, 4572820, 4594667, 4609535, 4609832, 4612221, 4623231, 4641716, 4642455, 4644081, 4649216, 4649994, 4651443, 4651600, 4654856, 4658353, 4662074, 4663439, 4669680, 4673036, 4680981, 4681661, 4687778, 4690512, 4690513, 4691522, 4692358, 4695810, 4697082, 4697083, 4697802, 4701645, 4709304, 4709305, 4719281, 4732749, 4739979, 4750820, 4750821, 4750823, 4756961, 4756962, 4770807, 4772543, 4777020, 4779422, 4785202, 4786475, 4794578, 4798006, 4802124, 4812778, 4816837, 4820336, 4822416, 4831309.

Product: NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4707501

Lot Numbers:
4707501
Product: NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4406489, 4562012, 4638454, 4712616, 4771914, 4778741, 4782797.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 60190043, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4245062, 4274403, 4279305, 4304178, 4310119, 4316975, 4344829, 4346377, 4362805, 4384732, 4388780, 4397288, 4413836, 4431569, 4436695, 4447596, 4475859, 4504978, 4535475, 4548988, 4572825, 4604165, 4612867, 4623158, 4641633, 4646958, 4649902, 4654829, 4656269, 4662474, 4666874, 4672653, 4681120, 4683507, 4690117, 4691459, 4694464, 4697096, 4697097, 4705210, 4708411, 4714933, 4719224, 4729424, 4744391, 4747617, 4762965, 4776983, 4783334, 4795711, 4808549, 4819169, 4822411, 4831699.

Product: NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4802267

Lot Numbers:
4802267
Product: NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4467896

Lot Numbers:
4467896
Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 60200057, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4256783, 4460497, 4575427, 4582488, 4638692, 4656910.

Lot Numbers:
4256783
Product: NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4693027, 4693271, 4693804, 4701037, 4705269, 4728884, 4733063, 4750828, 4764547, 4770885, 4779423, 4816850, 4822738, 4829934.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4692107 and 4757752

Product: NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4245786, 4248982, 4252309, 4260234, 4268141, 4279218, 4288402, 4298225, 4314481, 4320621, 4329211, 4337129, 4344176, 4353785, 4361710, 4372511, 4384175, 4393701, 4398980, 4403990, 4423304, 4457003, 4466333, 4469607, 4476888, 4485248, 4492442, 4498101, 4501790, 4507503, 4514700, 4528475, 4538380, 4548574, 4557974, 4565199, 4575422, 4579968, 4597587, 4613549, 4616353, 4636559, 4639117, 4642346, 4643978, 4644874, 4645905, 4649110, 4651282, 4651492, 4663423, 4667161, 4668890, 4671604, 4675060, 4676056, 4677276, 4678679, 4681618, 4685667, 4687664, 4690797, 4692101, 4693222, 4694581, 4697711, 4699670, 4701307, 4704014, 4706057, 4706979, 4707971, 4709279, 4721006, 4722335, 4725913, 4731836, 4731978, 4735580, 4739507, 4746790, 4749728, 4754079, 4757753, 4760072, 4763823, 4767249, 4769237, 4773706, 4774613, 4778708, 4783821, 4790213, 4792502, 4794061, 4799220, 4802066, 4804507, 4814927, 4817339, 4819622, 4820297, 4822238, 4828380, 4831134, 4833530, 4835324.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4264873, 4286294, 4288370, 4306895, 4387109, 4416451, 4426311, 4451972, 4487486, 4499675, 4501024, 4525968, 4616390, 4619388, 4623073, 4655776, 4657836, 4659829, 4669429, 4675080, 4692322, 4739538, 4749797, 4769368, 4774274, 4777753, 4819049, 4828035.

Product: NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4399506

Lot Numbers:
4399506
Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4440346

Lot Numbers:
4440346
Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 600207212, STERILE, Rx ONLY --- For single use only. ---Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4652732, 4656169, 4657278, 4673716, 4694148, 4729301, 4748825, 4778748, 4790216, 4816281, 4817327, 4830491.

Product: NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4798703

Lot Numbers:
4798703
Product: NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4600293, 4604109, 4630591, 4638147, 4643561, 4651008, 4798764, 4805945.

Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 60041632, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4323681, 4398529, 4699521.

Product: NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4805300

Lot Numbers:
4805300
Product: NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems

Lots 4245438, 4307306, 4313219, 4419588, 4445584, 4447457, 4472967, 4475647, 4505373, 4524286, 4535874, 4573138, 4603929, 4612618, 4614394, 4640699, 4641404, 4645492, 4654171, 4655816, 4661649, 4694300, 4696849, 4697815, 4705292, 4706335, 4716368, 4721360, 4750594, 4753523, 4767694, 4767695, 4822754.

Product: NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4720602 and 4725234

Product: NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4715969 and 4735572

Product: NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4653565 and 4653754

Product: NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4639731, 4645195, 4657980, 4661601, 4664394, 4677511, 4786821, 4820468, 4821432, 4832181.

Product: NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4361732, 4445198, 4512179, 4596980, 4608449, 4657491, 4671286, 4699834, 4742947, 4764114, 4772460, 4806954, 4812145.

Product: NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4251421, 4261990, 4282367, 4292263, 4310927, 4332731, 4337139, 4355702, 4361719, 4374408, 4387108, 4406974, 4421890, 4428330, 4440410, 4442751, 4472601, 4489987, 4502014, 4517118, 4549816, 4561987, 4576305, 4584997, 4596976, 4598870, 4614644, 4620378, 4622543, 4637814, 4640980, 4643981, 4651520, 4657147, 4657812, 4672188.

Product: NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, STERILE, Rx ONLY - For single use only. --- Device Listing Number D136588 NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4683419

Lot Numbers:
4683419
Product: NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE, Rx ONLY ---For single use only. Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lot 4589519

Lot Numbers:
4589519
Product: NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

Lots 4244975, 4251615, 4269276, 4292593, 4310081, 4344776, 4374583, 4384503, 4413658, 4447492, 4505410, 4535348, 4569287, 4572788, 4604137, 4610092, 4612832, 4630601, 4630602, 4638044, 4681013, 4690175, 4705330, 4717942, 4731420, 4772544, 4812433.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 70322
Status: Resolved
Manufacturer: Navilyst Medical, Inc
Manufactured In: United States
Units Affected: 60 products (15 units; 19 units; 32 units; 4 units; 1355 units; 136 units; 438 units; 489 units; 927; 16 units; 454 units; 161 units; 2409 units; 30 units; 562 units; 5 units; 602 units; 105 units; 62 units; 64 units; 5 units; 390 units; 411 units; 124 units; 10 units; 512 units; 1 unit; 5 units; 22 units; 1008 units; 2 units; 69 units; 1610 units; 1 unit; 11 units; 180 units; 1 unit; 2 units; 33 units; 238 units; 17 units; 2502 units; 61 units; 13 units; 2 units; 18 units; 2 units; 260 units; 5 units; 1 unit; 255 units; 3 units; 7 units; 70 units; 74 units; 20 units; 541 units; 3 units; 1 unit; 133 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.