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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 23, 2003
Date PostedJanuary 09, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall NumberZ-0313-04
Recall Event ID 27936
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
ProductEasypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120
Code Information Lot number 132185.
FEI Number 3011270181
Recalling Firm/
Manufacturer		 I-Flow Corporation
20202 Windrow Dr
Lake Forest CA 92630-8152
For Additional Information ContactShane 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
ActionFirm sent recall letter to thier only customer in France on August 23, 2002.
Quantity in Commerce950
DistributionOnly to France, and one customer.
Total Product Life CycleTPLC 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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