Z-1204-2010

Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only

Name: Z-1204-2010 Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only
Creator: Churchill Medical Systems, Inc.
Published: 2010-01-29
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2010-01-29 / Terminated / root cause: labeling and UDI

FDA source

Churchill Medical Systems, Inc. began a recall of Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only Product Code: 1015.122M Vygon/Churchill Medical System on 2010-01-29. The reason FDA records is "Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1204-2010
Status: Terminated
Initiated: 2010-01-29
Posted: 2010-03-24
Terminated: 2010-09-23
Recalling firm: Vygon Mfg
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
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml.
Root cause tag: labeling and UDI
FDA 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 in commerce: 99,900 eaches
Distribution: Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.
Product codes and lots: Lot Numbers: 910107, Exp: 2014/11 911165, Exp. 2014/12

Product code KNT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)