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.
FDA Recall Z-0850-03 · Posted 2003-05-20
Recalling FirmVygon Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2003-04-09
Date Terminated2006-10-03
Product Quantity20
Reason for Recall
Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.