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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 09, 2003
Date Posted May 20, 2003
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = VYGON CORP.
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