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Class 2 Device Recall Easy Pump LT 6024 |
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Date Initiated by Firm |
February 11, 2008 |
Date Posted |
September 14, 2009 |
Recall Status1 |
Terminated 3 on February 04, 2010 |
Recall Number |
Z-2111-2009 |
Recall Event ID |
50802 |
510(K)Number |
K052117
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Product Classification |
Pump, infusion, elastomeric - Product Code MEB
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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 CA 92630-8152
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For Additional Information Contact |
949-206-2700
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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
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FDA Determined Cause 2 |
Labeling mix-ups |
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
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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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510(K) Database |
510(K)s with Product Code = MEB and Original Applicant = I-FLOW CORP.
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