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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 Syringesee related information
Date Initiated by FirmJanuary 29, 2010
Date PostedMarch 24, 2010
Recall Status1 Terminated 3 on September 23, 2010
Recall NumberZ-1203-2010
Recall Event ID 54481
510(K)NumberK060944 K991918 
Product Classification Tubes, Gastrointestinal (And Accessories) - Product Code KNT
ProductVygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 Product Code: 1015.062M Vygon/Churchill Medical System
Code Information Lot Numbers: 910118 Exp: 2014/10  
Recalling Firm/
Manufacturer		 Churchill Medical Systems, Inc.
87 Venture Drive
Dover NH 03820-5914
For Additional Information Contact
603-743-5988
Manufacturer Reason
for Recall		Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml.
FDA Determined
Cause 2		Labeling Change Control
ActionChurchill 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 Commerce29,700 eaches
DistributionNationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.
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 = KNT
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