I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicate
FDA device recall Z-2111-2009 · posted 2009-09-14 · Terminated
Recall details
- Recalling firm
- I-Flow Corporation
- 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
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 4,450 Distributed
- Distribution
- Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.
- Date initiated
- 2008-02-11
- Date posted
- 2009-09-14
- Date terminated
- 2010-02-04
- Location
- Lake Forest, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) (K052117) | I-Flow Corp. | 2005-09-09 |