FDA Medical Device Recalls (openFDA)
Churchill Medical Systems, Inc.: Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only Product Code: 1015.122M Vygon/Churchill Medical System
- Recall number
- Z-1204-2010
- Recalling firm
- Churchill Medical Systems, Inc.
- 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
- Status
- Terminated
- Initiated
- 2010-01-29
- Posted
- 2010-03-24
- Terminated
- 2010-09-23
- Reason
- Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 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
- 99,900 eaches
- Distribution
- Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.
- Lot, serial or model codes
- Lot Numbers: 910107, Exp: 2014/11 911165, Exp. 2014/12
- 510(k) numbers
- ["K060944","K991918"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1000120555
- Firm city
- Dover
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28