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Terminated

Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 Product Code: 1015.062M Vygon/Churchill Medical System

FDA Recall Z-1203-2010 · Posted 2010-03-24

Recalling FirmChurchill Medical Systems, Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2010-01-29
Date Terminated2010-09-23
Product Quantity29,700 eaches

Reason for Recall

Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml.

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060944NUTRISAFE 2Vygon Corp. · 2006-09-15K991918NUTRISAFE EXTENSION TUBEVygon Corp. · 1999-10-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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