Recall Z-0850-03 ยท DQO Catheter, Intravascular, Diagnostic
Vygon Corporation
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 & I
| Date | May 20, 2003 (initiated Apr 9, 2003) |
| Status | Terminated |
| Reason | Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954112 | VYGON LIFEVAC MID-LINE TRAY Vygon Corp., May 9, 1996 |