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
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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
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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 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = LZH
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