Date Initiated by Firm |
August 23, 2003 |
Date Posted |
January 09, 2004 |
Recall Status1 |
Terminated 3 on January 04, 2005 |
Recall Number |
Z-0313-04 |
Recall Event ID |
27936 |
Product Classification |
Pump, Infusion, Elastomeric - Product Code MEB
|
Product |
Easypump LT 100-200
Elastomeric Infusion Pump (100 ml x 0.5 ml/hr)
Part number: 5001120 |
Code Information |
Lot number 132185. |
Recalling Firm/ Manufacturer |
I-Flow Corporation 20202 Windrow Dr Lake Forest CA 92630-8152
|
For Additional Information Contact |
Shane Noehre 949-206-2653
|
Manufacturer Reason for Recall |
Some pumps run at 2 ml/hr instead of 0.5 ml/hr.
|
FDA Determined Cause 2 |
Other |
Action |
Firm sent recall letter to thier only customer in France on August 23, 2002. |
Quantity in Commerce |
950 |
Distribution |
Only to France, and one customer. |
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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