Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Nutrisafe 2 Syringe

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 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-1204-2010
Recall Event ID 54481
510(K)NumberK060944 K991918 
Product Classification Gastrointestinal Tubes and Accessories - Product Code KNT
ProductVygon 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/
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 : 12 ml syringe mislabeled as 10 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 Commerce99,900 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
-
-