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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 March 18, 2003
Date Posted April 18, 2003
Recall Status1 Terminated 3 on November 20, 2003
Recall Number Z-0741-03
Recall Event ID 25903
510(K)Number k991513  
Product Easypump LT 60-24
Easypump Infusion Pump (60 ml x 2 ml/hr)
Code Information Lot numbers 04434366/2A2469 and 04434367/2A2470.
Recalling Firm/
Manufacturer		 I-Flow Corporation
20202 Windrow Dr
Lake Forest CA 92630
Manufacturer Reason
for Recall		 Overinfusion due to misassembly.
FDA Determined
Cause 2		 Other
Action Recall letter was sent to sole distributor, B Braun FRance by email on 3/18/2003. Return of stock and subrecall was requested. Consignee has acknowledged implementing subrecall.
Quantity in Commerce 2638 units
Distribution Only in France to distributor B. Braun Medical, France
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 = and Original Applicant = I-FLOW CORP.
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