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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 09, 2003
Date PostedMay 20, 2003
Recall Status1 Terminated 3 on October 03, 2006
Recall NumberZ-0850-03
Recall Event ID 26213
510(K)NumberK954112 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
ProductNeonatal 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.
Code Information Lot #031203MA Exp. 7/1/2005
FEI Number 2245270
Recalling Firm/
Manufacturer		 Vygon Corporation
1 Madison Street
East Rutherford NJ 07073
For Additional Information ContactJohn 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
ActionRecalls 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 Commerce20
DistributionProduct 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 CycleTPLC 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) Database510(K)s with Product Code = DQO
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