Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 Product Code: 1015.062M Vygon/Churchill Medical Syste
FDA device recall Z-1203-2010 · posted 2010-03-24 · Terminated
Recall details
- Recalling firm
- Churchill Medical Systems, Inc.
- Reason for recall
- Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 29,700 eaches
- Distribution
- Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.
- Date initiated
- 2010-01-29
- Date posted
- 2010-03-24
- Date terminated
- 2010-09-23
- Location
- Dover, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NUTRISAFE 2 (K060944) | Vygon Corp. | 2006-09-15 |
| NUTRISAFE EXTENSION TUBE (K991918) | Vygon Corp. | 1999-10-29 |