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NAVILYST MEDICAL, INC.

Last updated May 24, 2026

What NAVILYST MEDICAL, INC. makes

Navilyst Medical produces single-use and reusable medical devices for vascular access and monitoring, including angiography kits, peripherally-inserted central venous catheters, stopcocks, invasive-pressure transducers, peripheral IV cannulas, guidewires, angiographic syringes, and blood pressure monitoring tubing sets.

The company’s portfolio includes Class I and Class II devices, all listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Navilyst Medical, Inc. manufacture?

Navilyst Medical, Inc. specializes in vascular access and monitoring devices. Their portfolio includes single-use and reusable products like angiography kits, peripherally-inserted central venous catheters (PICCs), stopcocks, invasive-pressure external transducers, peripheral intravenous cannulas, guidewires for cardiac and peripheral vascular use, angiographic syringes, and invasive blood pressure monitoring tubing sets. These devices are designed for procedures requiring precise vascular access and real-time monitoring.

Where is Navilyst Medical, Inc. based?

Navilyst Medical, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical device manufacturing and distribution.

Are Navilyst Medical, Inc.’s devices listed in any regulatory registries?

Yes, Navilyst Medical’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning them a standardized UDI, which includes details like the manufacturer, device model, and production batch. Listing in the UDI database supports transparency and traceability in the healthcare industry.

How are Navilyst Medical, Inc.’s devices classified under U.S. regulations?

Navilyst Medical’s devices fall into two primary classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional premarket notifications (510(k)s) to demonstrate safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, as determined by FDA guidelines.

What distinguishes Navilyst Medical’s angiography-related products from other devices in their portfolio?

Navilyst Medical’s angiography kits and related products, such as angiographic syringes and guidewires, are tailored for procedures requiring detailed visualization of blood vessels. These devices are designed to work together to ensure precise contrast injection, catheter navigation, and real-time imaging during angiographic studies. Unlike general vascular access devices, they incorporate features optimized for interventional radiology and cardiology, where accuracy and reliability are critical to patient outcomes.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: angiodynamics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(518)795-1676
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 809699023

Catalogue (7554)

Page 3 of 152

Device	Model / Reference	Registries	Class	Status
StarBurst	700-104077	FDA UDI	Class II	Active
Namic	60141304	FDA UDI	N/A	Active
Namic	600605611	FDA UDI	N/A	Active
Namic	65070593	FDA UDI	N/A	Active
Namic	606604322	FDA UDI	N/A	Active
Celerity	H787471400	FDA UDI	Class II	Active
Navilyst Medical	PKM110558S	FDA UDI	N/A	Active
Namic	601905417	FDA UDI	N/A	Active
Namic	6061102141	FDA UDI	N/A	Active
BioFlo	03-809	FDA UDI	Class II	Active
AngioDynamics	91413	FDA UDI	N/A	Active
Namic	601832318	FDA UDI	N/A	Active
Namic	60220953	FDA UDI	N/A	Active
Namic	60032241	FDA UDI	N/A	Active
Namic	651312010	FDA UDI	N/A	Active
Namic	65620687	FDA UDI	N/A	Active
Namic	60150103	FDA UDI	N/A	Active
Namic	PK111179S	FDA UDI	N/A	Active
Namic	PK060622S	FDA UDI	N/A	Active
Namic	60023591	FDA UDI	N/A	Active
Namic	63150121	FDA UDI	N/A	Active
Namic	60131743	FDA UDI	N/A	Active
Namic	6561091531	FDA UDI	N/A	Active
Namic	PK1831315S	FDA UDI	N/A	Active
Namic	65620932	FDA UDI	N/A	Active
Namic	81400025	FDA UDI	Class II	Active
Namic	63040241	FDA UDI	N/A	Active
Namic	6061061301	FDA UDI	N/A	Active
BioFlo	PKM3070943S	FDA UDI	Class II	Active
BioFlo	45896	FDA UDI	Class II	Active
Namic	90711482	FDA UDI	Class I	Active
Namic	652101511	FDA UDI	N/A	Active
Namic	60020237	FDA UDI	N/A	Active
Namic	60620886	FDA UDI	N/A	Active
Namic	606208919	FDA UDI	N/A	Active
Namic	60194293	FDA UDI	N/A	Active
Namic	60223011	FDA UDI	N/A	Active
BioFlo	02-805	FDA UDI	Class II	Active
Namic	603060311	FDA UDI	N/A	Active
Namic	606604328	FDA UDI	N/A	Active
Lifeguard	LG-22-75	FDA UDI	Class II	Active
Namic	88001203	FDA UDI	Class II	Active
Namic	65701012	FDA UDI	N/A	Active
Namic	60070458	FDA UDI	N/A	Active
Xcela	45715	FDA UDI	Class II	Active
Namic	63120571	FDA UDI	N/A	Active
Namic	60022655	FDA UDI	N/A	Active
BioFlo	60M060104	FDA UDI	Class II	Active
Namic	60122744	FDA UDI	N/A	Active
Namic	65040612	FDA UDI	N/A	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (92)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Navilyst Medical, Inc. has 92 recall records initiated between August 6, 2008, and January 9, 2015, all marked as terminated. The reasons cited include unsupported expiration dating potentially compromising sterility in Fluid Management Convenience Kits, incomplete sterilization of catheter boxes, non-coring needles causing septum damage, open syringe seals affecting sterility, sterilization barrier breaches, loose plastic particulates in fluid pathways, damaged manifolds risking air injection, and higher-than-expected catheter tip fragmentation rates in biliary drainage catheters. Some recalls were initiated following notifications from external manufacturers regarding their own product issues.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jan 9, 2015	Z-1204-2015	—	terminated	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.
Jan 9, 2015	Z-1187-2015	—	terminated	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.
Jan 9, 2015	Z-1158-2015	—	terminated	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.
Jan 9, 2015	Z-1189-2015	—	terminated	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.
Jan 9, 2015	Z-1205-2015	—	terminated	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.
Jan 9, 2015	Z-1181-2015	—	terminated	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.
Jan 9, 2015	Z-1148-2015	—	terminated	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.
Jan 9, 2015	Z-1156-2015	—	terminated	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.
Jan 9, 2015	Z-1177-2015	—	terminated	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.
Jan 9, 2015	Z-1154-2015	—	terminated	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.
Jan 9, 2015	Z-1155-2015	—	terminated	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.
Jan 9, 2015	Z-1198-2015	—	terminated	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.
Jan 9, 2015	Z-1172-2015	—	terminated	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.
Jan 9, 2015	Z-1195-2015	—	terminated	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.
Jan 9, 2015	Z-1162-2015	—	terminated	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.
Jan 9, 2015	Z-1207-2015	—	terminated	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.
Jan 9, 2015	Z-1197-2015	—	terminated	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.
Jan 9, 2015	Z-1203-2015	—	terminated	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.
Jan 9, 2015	Z-1159-2015	—	terminated	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.
Jan 9, 2015	Z-1153-2015	—	terminated	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.
Jan 9, 2015	Z-1182-2015	—	terminated	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.
Jan 9, 2015	Z-1196-2015	—	terminated	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.
Jan 9, 2015	Z-1199-2015	—	terminated	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.
Jan 9, 2015	Z-1160-2015	—	terminated	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.
Jan 9, 2015	Z-1152-2015	—	terminated	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.
Jan 9, 2015	Z-1191-2015	—	terminated	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.
Jan 9, 2015	Z-1165-2015	—	terminated	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.
Jan 9, 2015	Z-1163-2015	—	terminated	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.
Jan 9, 2015	Z-1192-2015	—	terminated	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.
Jan 9, 2015	Z-1173-2015	—	terminated	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.
Jan 9, 2015	Z-1175-2015	—	terminated	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.
Jan 9, 2015	Z-1200-2015	—	terminated	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.
Jan 9, 2015	Z-1171-2015	—	terminated	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.
Jan 9, 2015	Z-1206-2015	—	terminated	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.
Jan 9, 2015	Z-1150-2015	—	terminated	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.
Jan 9, 2015	Z-1202-2015	—	terminated	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.
Jan 9, 2015	Z-1179-2015	—	terminated	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.
Jan 9, 2015	Z-1178-2015	—	terminated	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.
Jan 9, 2015	Z-1176-2015	—	terminated	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.
Jan 9, 2015	Z-1193-2015	—	terminated	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.
Jan 9, 2015	Z-1169-2015	—	terminated	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.
Jan 9, 2015	Z-1201-2015	—	terminated	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.
Jan 9, 2015	Z-1166-2015	—	terminated	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.
Jan 9, 2015	Z-1183-2015	—	terminated	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.
Jan 9, 2015	Z-1194-2015	—	terminated	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.
Jan 9, 2015	Z-1184-2015	—	terminated	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.
Jan 9, 2015	Z-1186-2015	—	terminated	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.
Jan 9, 2015	Z-1149-2015	—	terminated	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.
Jan 9, 2015	Z-1168-2015	—	terminated	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.
Jan 9, 2015	Z-1185-2015	—	terminated	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.
Jan 9, 2015	Z-1170-2015	—	terminated	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.
Jan 9, 2015	Z-1190-2015	—	terminated	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.
Jan 9, 2015	Z-1151-2015	—	terminated	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.
Jan 9, 2015	Z-1164-2015	—	terminated	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.
Jan 9, 2015	Z-1180-2015	—	terminated	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.
Jan 9, 2015	Z-1161-2015	—	terminated	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.
Jan 9, 2015	Z-1167-2015	—	terminated	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.
Jan 9, 2015	Z-1188-2015	—	terminated	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.
Jan 9, 2015	Z-1174-2015	—	terminated	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.
Jan 9, 2015	Z-1157-2015	—	terminated	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.
Aug 25, 2014	Z-0035-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0027-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0034-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0030-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0028-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0031-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0026-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0036-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0029-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0032-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0033-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Aug 25, 2014	Z-0025-2015	—	terminated	NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Nov 25, 2013	Z-0826-2014	—	terminated	Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
Dec 19, 2011	Z-0821-2012	—	terminated	Navilyst Medical has received reports of damaged manifolds contained in certain NAMIC Convenience Kits which may result in air injection during certain procedures.
Feb 4, 2011	Z-0647-2012	—	terminated	Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
Feb 4, 2011	Z-0648-2012	—	terminated	Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
May 24, 2010	Z-0015-2011	—	terminated	One box containing five catheters did not complete the sterilization process prior to distribution.
May 13, 2010	Z-1880-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1882-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1886-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1875-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1876-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1881-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1883-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1874-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1877-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1885-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1878-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1884-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1879-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
May 13, 2010	Z-1887-2010	—	terminated	FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
Aug 6, 2008	Z-0287-2009	—	terminated	Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.