FDA event 70322 · Recall Observatory

device · product 1 of 60

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.

Z-1148-2015

Recall number: Z-1148-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4476878, 4638166, 4677141.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 2 of 60

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.

Z-1149-2015

Recall number: Z-1149-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 3 of 60

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.

Z-1150-2015

Recall number: Z-1150-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 4 of 60

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.

Z-1151-2015

Recall number: Z-1151-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4364622 and 4376537.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 5 of 60

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.

Z-1152-2015

Recall number: Z-1152-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 1355 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 6 of 60

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.

Z-1153-2015

Recall number: Z-1153-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 136 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 7 of 60

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.

Z-1154-2015

Recall number: Z-1154-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 438 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 8 of 60

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.

Z-1155-2015

Recall number: Z-1155-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 489 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 9 of 60

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.

Z-1156-2015

Recall number: Z-1156-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 927

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 10 of 60

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.

Z-1157-2015

Recall number: Z-1157-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4346227, 4510688, 4644193, 4692124, 4694166.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 11 of 60

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.

Z-1158-2015

Recall number: Z-1158-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 454 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 12 of 60

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.

Z-1159-2015

Recall number: Z-1159-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 161 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 13 of 60

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.

Z-1160-2015

Recall number: Z-1160-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 2409 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 14 of 60

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.

Z-1161-2015

Recall number: Z-1161-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 15 of 60

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.

Z-1162-2015

Recall number: Z-1162-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 562 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 16 of 60

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.

Z-1163-2015

Recall number: Z-1163-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4393719, 4617238, 4717511.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 17 of 60

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.

Z-1164-2015

Recall number: Z-1164-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 602 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 18 of 60

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.

Z-1165-2015

Recall number: Z-1165-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 105 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 19 of 60

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.

Z-1166-2015

Recall number: Z-1166-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 20 of 60

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.

Z-1167-2015

Recall number: Z-1167-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 21 of 60

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.

Z-1168-2015

Recall number: Z-1168-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4426312, 4708385, 4799474.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 22 of 60

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.

Z-1169-2015

Recall number: Z-1169-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 390 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 23 of 60

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.

Z-1170-2015

Recall number: Z-1170-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 411 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 24 of 60

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.

Z-1171-2015

Recall number: Z-1171-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 124 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 25 of 60

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.

Z-1172-2015

Recall number: Z-1172-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4426279, 4500022, 4519371, 4637654, 4651033.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 26 of 60

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.

Z-1173-2015

Recall number: Z-1173-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 512 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 27 of 60

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.

Z-1174-2015

Recall number: Z-1174-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4500974

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 28 of 60

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.

Z-1175-2015

Recall number: Z-1175-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4663410 and 4664414.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 29 of 60

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.

Z-1176-2015

Recall number: Z-1176-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 30 of 60

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.

Z-1177-2015

Recall number: Z-1177-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 1008 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 31 of 60

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.

Z-1178-2015

Recall number: Z-1178-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4608719

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 32 of 60

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.

Z-1179-2015

Recall number: Z-1179-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 69 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 33 of 60

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.

Z-1180-2015

Recall number: Z-1180-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 1610 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 34 of 60

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.

Z-1181-2015

Recall number: Z-1181-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4707501

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 35 of 60

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.

Z-1182-2015

Recall number: Z-1182-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 36 of 60

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.

Z-1183-2015

Recall number: Z-1183-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 37 of 60

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.

Z-1184-2015

Recall number: Z-1184-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4802267

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 38 of 60

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.

Z-1185-2015

Recall number: Z-1185-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4467896

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 39 of 60

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.

Z-1186-2015

Recall number: Z-1186-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 40 of 60

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.

Z-1187-2015

Recall number: Z-1187-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 238 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 41 of 60

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.

Z-1188-2015

Recall number: Z-1188-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4692107 and 4757752

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 42 of 60

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.

Z-1189-2015

Recall number: Z-1189-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 2502 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 43 of 60

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.

Z-1190-2015

Recall number: Z-1190-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 61 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 44 of 60

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.

Z-1191-2015

Recall number: Z-1191-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4399506

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 45 of 60

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.

Z-1192-2015

Recall number: Z-1192-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4440346

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 46 of 60

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.

Z-1193-2015

Recall number: Z-1193-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 47 of 60

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.

Z-1194-2015

Recall number: Z-1194-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4798703

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 48 of 60

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.

Z-1195-2015

Recall number: Z-1195-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 260 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 49 of 60

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.

Z-1196-2015

Recall number: Z-1196-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4323681, 4398529, 4699521.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 50 of 60

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.

Z-1197-2015

Recall number: Z-1197-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4805300

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 51 of 60

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

Z-1198-2015

Recall number: Z-1198-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 255 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 52 of 60

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.

Z-1199-2015

Recall number: Z-1199-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4720602 and 4725234

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 53 of 60

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.

Z-1200-2015

Recall number: Z-1200-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4715969 and 4735572

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 54 of 60

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.

Z-1201-2015

Recall number: Z-1201-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 70 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots 4653565 and 4653754

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 55 of 60

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.

Z-1202-2015

Recall number: Z-1202-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 74 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 56 of 60

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.

Z-1203-2015

Recall number: Z-1203-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 57 of 60

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.

Z-1204-2015

Recall number: Z-1204-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 541 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 58 of 60

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.

Z-1205-2015

Recall number: Z-1205-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4683419

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 59 of 60

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.

Z-1206-2015

Recall number: Z-1206-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot 4589519

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

device · product 60 of 60

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.

Z-1207-2015

Recall number: Z-1207-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Navilyst Medical, Inc
Quantity: 133 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

Event summary

Source snapshots represented here

Every recalled product in this event

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