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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 Compatsee related information
Date Initiated by FirmJanuary 27, 2003
Date PostedMarch 05, 2003
Recall Status1 Terminated 3 on June 24, 2004
Recall NumberZ-0608-03
Recall Event ID 25470
510(K)NumberK940556 
Product Classification Pump, Infusion, Enteral - Product Code LZH
ProductCompat 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 2
Other
ActionThe 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 Commerce803 cases (30 tube sets per case)
DistributionNationwide in the United States and to Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LZH
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