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.
This recall has been terminated (originally issued May 20, 2003).
- Company
- Vygon Corporation
- Recall Initiated
- April 9, 2003
- Posted
- May 20, 2003
- Terminated
- October 3, 2006
- Recall Number
- Z-0850-03
- Quantity
- 20
- Firm Location
- East Rutherford, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
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.
Lot / Code Info
Lot #031203MA Exp. 7/1/2005
Root Cause
Other
Action Taken
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.