Class 2 Device Recall

• Date Initiated by Firm: April 09, 2003
• Date Posted: May 20, 2003
• Recall Status: Terminated on October 03, 2006
• Recall Number: Z-0849-03
• Recall Event ID: 26213
• 510(K)Number: K954112
• Product Classification: Catheter, Intravascular, Diagnostic - Product Code DQO
• Product: 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.
• Code Information: Lot #B01A48 Exp. 11/2007
• FEI Number: 2245270
• Recalling Firm/ Manufacturer: Vygon Corporation; 1 Madison Street; East Rutherford NJ 07073
• For Additional Information Contact: John A. Leaity; 800-544-4907 Ext. 23
• Manufacturer Reason for Recall: Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQO