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NAVILYST MEDICAL, INC.

Last updated May 24, 2026

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 1 of 152

Device	Model / Reference	Registries	Class	Status
Namic	PK040046S	FDA UDI	N/A	Active
Namic	60120059	FDA UDI	N/A	Active
Namic	60030068	FDA UDI	N/A	Active
Namic	63120104	FDA UDI	N/A	Active
Namic	60181886	FDA UDI	N/A	Active
BioFlo	60M071832	FDA UDI	Class II	Active
BioFlo	PKM1220220S	FDA UDI	Class II	Active
Namic	60040134	FDA UDI	N/A	Active
Namic	65600187	FDA UDI	N/A	Active
BioFlo	60M701533	FDA UDI	Class II	Active
Namic	60139096	FDA UDI	N/A	Active
Navilyst Medical	PKM1803415S	FDA UDI	N/A	Active
Namic	601417011	FDA UDI	N/A	Active
Namic	60080793	FDA UDI	N/A	Active
Namic	6561083321	FDA UDI	N/A	Active
Namic	650202318	FDA UDI	N/A	Active
Namic	63184193	FDA UDI	N/A	Active
Namic	650205511	FDA UDI	N/A	Active
Namic	650703010	FDA UDI	N/A	Active
Namic	65034672	FDA UDI	N/A	Active
Namic	656209323	FDA UDI	N/A	Active
Namic	81021102	FDA UDI	Class II	Active
Namic	600503712	FDA UDI	N/A	Active
Namic	65016491	FDA UDI	N/A	Active
Namic	60010535	FDA UDI	N/A	Active
Namic	6061115791	FDA UDI	N/A	Active
BioFlo	60M122942	FDA UDI	Class II	Active
BioFlo	PKM1613613S	FDA UDI	Class II	Active
Namic	60036971	FDA UDI	N/A	Active
Namic	60035982	FDA UDI	N/A	Active
Namic	60023002	FDA UDI	N/A	Active
BioFlo	45870	FDA UDI	Class II	Active
Namic	60122784	FDA UDI	N/A	Active
Navilyst	97000205	FDA UDI	Class II	Active
BioFlo	60M185981	FDA UDI	Class II	Active
Xcela	45742	FDA UDI	Class II	Active
Namic	70036148	FDA UDI	Class II	Active
Namic	60010032	FDA UDI	N/A	Active
Namic	65020436	FDA UDI	N/A	Active
Namic	60080732	FDA UDI	N/A	Active
Namic	63122363	FDA UDI	N/A	Active
Namic	70085005	FDA UDI	Class II	Active
Namic	60660321	FDA UDI	N/A	Active
Namic	602101511	FDA UDI	N/A	Active
Namic	652101519	FDA UDI	N/A	Active
Exodus	10415	FDA UDI	Class II	Unknown
Navilyst Medical	60M220854	FDA UDI	N/A	Active
Xcela	60M3067601	FDA UDI	Class II	Active
BioFlo	60M163422	FDA UDI	Class II	Active
Namic	64000996	FDA UDI	Class II	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.

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.