Date Initiated by Firm |
January 27, 2003 |
Date Posted |
March 05, 2003 |
Recall Status1 |
Terminated 3 on June 24, 2004 |
Recall Number |
Z-0607-03 |
Recall Event ID |
25470 |
510(K)Number |
K940556
|
Product Classification |
Pump, Infusion, Enteral - Product Code LZH
|
Product |
Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700 |
Code Information |
Item number 19930700, lot 3092D |
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 |
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 |
114 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
|