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U.S. Department of Health and Human Services

Class 2 Device Recall Easy Pump LT 6024

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 Class 2 Recall
Easy Pump LT 6024
see related information
Date Posted September 14, 2009
Recall Status1 Terminated on February 04, 2010
Recall Number Z-2111-2009
Recall Event ID 50802
Premarket Notification
510(K) Number
K052117 
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
Product I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management.
Code Information Lot Number: 612996.
Recalling Firm/
Manufacturer
I-Flow Corporation
20202 Windrow Dr
Lake Forest, California 92630-8152
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was included to show consignee what both the correct and incorrect part looks like). Lot 612996 was manufactured on January 6, 2006. As of February 7, 2008, there have been no further complaints received on t
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action I-Flow Corp. issued an "Important Recall Information" letter dated February 7, 2008 informing Consignees to quarantine and return any remaining inventory and notify any end users of the affected lot. For further information, contact I-Flow Corp. at 1-949-206-2653.
Quantity in Commerce 4,450 Distributed
Distribution Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEB and Original Applicant = I-FLOW CORP.
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