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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 4 of 152

Device	Model / Reference	Registries	Class	Status
BioFlo	75034	FDA UDI	Class II	Active
Xcela	45676	FDA UDI	Class II	Active
Xcela	60M231601	FDA UDI	Class II	Active
Namic	600202611	FDA UDI	N/A	Active
Namic	65023008	FDA UDI	N/A	Active
Namic	65230539	FDA UDI	N/A	Active
Namic	65031863	FDA UDI	N/A	Active
Namic	70127402	FDA UDI	Class II	Active
Namic	63131611	FDA UDI	N/A	Active
Namic	60190501	FDA UDI	N/A	Active
Namic	60191311	FDA UDI	N/A	Active
Namic	602100610	FDA UDI	N/A	Active
Namic	PK070432S	FDA UDI	N/A	Active
Namic	60130423	FDA UDI	N/A	Active
Namic	91300013	FDA UDI	Class II	Active
Namic	65020211	FDA UDI	N/A	Active
Namic	60052032	FDA UDI	N/A	Active
Namic	65182191	FDA UDI	N/A	Active
Xcela	60M190751	FDA UDI	Class II	Active
Namic	60150221	FDA UDI	N/A	Active
Namic	60201623	FDA UDI	N/A	Active
Namic	60132304	FDA UDI	N/A	Active
Namic	65750073	FDA UDI	N/A	Active
BioFlo	60M194073	FDA UDI	Class II	Active
Namic	65137308	FDA UDI	N/A	Active
Exodus	10526	FDA UDI	Class II	Active
Namic	60617506	FDA UDI	N/A	Active
Namic	60182941	FDA UDI	N/A	Active
Namic	601222712	FDA UDI	N/A	Active
Namic	651910812	FDA UDI	N/A	Active
Namic	70127463	FDA UDI	Class II	Active
Namic	PK0702512S	FDA UDI	N/A	Active
Namic	70039352	FDA UDI	Class II	Active
Namic	6061045731	FDA UDI	N/A	Active
Namic	60190555	FDA UDI	N/A	Active
Namic	601826340	FDA UDI	N/A	Active
Navilyst	97000233	FDA UDI	Class II	Unknown
Namic	90712122	FDA UDI	Class I	Active
Namic	90703050	FDA UDI	Class II	Active
Namic	601323210	FDA UDI	N/A	Active
Namic	PK195002S	FDA UDI	N/A	Active
Namic	60012313	FDA UDI	N/A	Active
Namic	65131655	FDA UDI	N/A	Active
BioFlo	45890	FDA UDI	Class II	Active
Namic	60011611	FDA UDI	N/A	Active
Namic	656000784	FDA UDI	N/A	Active
Xcela	55718	FDA UDI	Class II	Active
Namic	651502638	FDA UDI	N/A	Active
Namic	70058217	FDA UDI	Class II	Active
Namic	65230192	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.