Devices

Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray.

Model / Serial
Lot #031203MA Exp. 7/1/2005
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.
Product Description
Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. The catheter tray and its respective accessories are manufactured in the US by Vygon. Sterilization of this catheter tray occurs via EtO by North American Sterilization and Packaging, Franklin, NJ. Labeled as Neonatal Catheter & Insertion Tray.
Manufacturer
Vygon Corporation
1 Event
- Recall of Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray.

Manufacturer

Vygon Corporation

Manufacturer Address
Vygon Corporation, 1 Madison Street, East Rutherford NJ 07073
Source
USFDA

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