Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. cat
FDA device recall Z-0850-03 · posted 2003-05-20 · Terminated
Recall details
- Recalling firm
- Vygon Corporation
- Reason for recall
- Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 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.
- Date initiated
- 2003-04-09
- Date posted
- 2003-05-20
- Date terminated
- 2006-10-03
- Location
- East Rutherford, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VYGON LIFEVAC MID-LINE TRAY (K954112) | Vygon Corp. | 1996-05-09 |