Z-0850-03

Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable...

Name: Z-0850-03 Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable...
Creator: Vygon Corporation
Published: 2003-04-09
License: https://open.fda.gov/license/

Vygon U.S.A. / initiated 2003-04-09 / Terminated / root cause: packaging

FDA source

Vygon Corporation began a 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... on 2003-04-09. The reason FDA records is "Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0850-03
Status: Terminated
Initiated: 2003-04-09
Posted: 2003-05-20
Terminated: 2006-10-03
Recalling firm: Vygon U.S.A.
Product: 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.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
Root cause tag: packaging
FDA root cause: Other
Action: Recalls letters were sent out to customers and sales representatives on 4/9/2003. They were also notified via e-mails and phone calls on 4/9/2003.
Quantity in commerce: 20
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 codes and lots: Lot #031203MA Exp. 7/1/2005

Product code DQO

K954112Class IIVygon Lifevac Mid-Line TrayVygon Corp. / cleared 1996-05-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)