Recall Z-0849-03 ยท DQO Catheter, Intravascular, Diagnostic
Vygon Corporation
Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Included with this catheter is a 2 Fr. insertion sheath. Product is packaged in tyvek sealed plastic tray. Sterilization occurs via EtO in Germany.
| 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 | 51 |
| 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 |