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U.S. Department of Health and Human Services

Class 2 Device Recall Compat

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  Class 2 Device Recall Compat see related information
Date Initiated by Firm January 27, 2003
Date Posted March 05, 2003
Recall Status1 Terminated 3 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/
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 2
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