Recall Z-2111-2009 ยท MEB Pump, Infusion, Elastomeric
I-Flow Corporation
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.
| Date | Sep 14, 2009 (initiated Feb 11, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 4,450 Distributed |
| Distribution | Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) I-Flow Corp., Sep 9, 2005 |