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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
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

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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