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.
This recall has been terminated (originally issued September 14, 2009).
- Company
- I-Flow Corporation
- Recall Initiated
- February 11, 2008
- Posted
- September 14, 2009
- Terminated
- February 4, 2010
- Recall Number
- Z-2111-2009
- Quantity
- 4,450 Distributed
- Firm Location
- Lake Forest, CA
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.
Lot / Code Info
Lot Number: 612996.
Root Cause
Labeling mix-ups
Action Taken
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.