Class 2 Device Recall Compat

• Date Initiated by Firm: January 27, 2003
• Date Posted: March 05, 2003
• Recall Status: Terminated on June 24, 2004
• Recall Number: Z-0608-03
• Recall Event ID: 25470
• 510(K)Number: K940556
• Product Classification: Pump, Infusion, Enteral - Product Code LZH
• Product: Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200
• Code Information: Item number 19931200, lots 3152A and 3182A
• Recalling Firm/ Manufacturer: Novartis Nutrition Corp; 1541 Park Place Blvd; St Louis Park MN 55416
• Manufacturer Reason for Recall: Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.
• FDA Determined Cause: Other
• Action: The recall letter, dated January 31, 2003, requested that the consignees return the recalled products and notify 'end users' to stop using the products.
• Quantity in Commerce: 803 cases (30 tube sets per case)
• Distribution: Nationwide in the United States and to Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LZH and Original Applicant = SANDOZ NUTRITION