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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 19, 2002
Date Posted January 09, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall Number Z-0312-04
Recall Event ID 27911
510(K)Number K020862  
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
Product Eclipse Infusion Pump, 250 ml X 250 ml per hour)

Part 5001247
Code Information Lot 262073
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
Slower than expected infusion of medications, such as antibiotics.
FDA Determined
Cause 2
Other
Action All customers were contacted by telephone on 8/19/2002. Letters were also sent dated 8/27/2002. Recall is complete.
Quantity in Commerce 144
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 = MEB and Original Applicant = I-FLOW CORP.
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