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U.S. Department of Health and Human Services

Class 3 Device Recall Nutrisafe 2 Syringe

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  Class 3 Device Recall Nutrisafe 2 Syringe see related information
Date Initiated by Firm January 29, 2010
Date Posted March 24, 2010
Recall Status1 Terminated 3 on September 23, 2010
Recall Number Z-1204-2010
Recall Event ID 54481
510(K)Number K991918  K060944  
Product Classification Gastrointestinal Tubes and Accessories - Product Code KNT
Product Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only
Product Code: 1015.122M
Vygon/Churchill Medical System
Code Information Lot Numbers:   910107, Exp: 2014/11  911165, Exp. 2014/12 
Recalling Firm/
Churchill Medical Systems, Inc.
87 Venture Drive
Dover NH 03820-5914
For Additional Information Contact
Manufacturer Reason
for Recall
Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml.
FDA Determined
Cause 2
Labeling Change Control
Action Churchill Medical issued an Urgent: Product Advisory Customer Notification on January 29, 2010 to customers and distributors via overnight delivery. The letter identified the affected product along with the corresponding lot numbers and explained the problem. Accounts are requested to complete the enclosed form and fax it to 215-672-6740, attention Marie Benson. The affected products should be quarantined and customer service should be contacted to arrange return of product. Questions should be directed to Marie Benson at 800-473-5414.
Quantity in Commerce 99,900 eaches
Distribution Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.
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 = KNT and Original Applicant = VYGON CORP.