Recall Z-1203-2010 ยท KNT Tubes, Gastrointestinal (And Accessories)
Churchill Medical Systems, Inc.
Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 Product Code: 1015.062M Vygon/Churchill Medical System
| Date | Mar 24, 2010 (initiated Jan 29, 2010) |
| Status | Terminated |
| Reason | Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml. |
| Root cause | 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 | 29,700 eaches |
| Distribution | Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX. |
| FDA record | Open on fda.gov |