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.
FDA Recall Z-2111-2009 · Posted 2009-09-14
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Recalling FirmI-Flow Corporation
Recall StatusTerminated
Product CodeMEB
Date Initiated2008-02-11
Date Terminated2010-02-04
Product Quantity4,450 Distributed
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
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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