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I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr)… recallZ-2111-2009 · I-Flow Corporation · initiated Feb 11, 2008

Terminated All recalls posted in September 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from I-Flow Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-2111-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 11, 2008
Posted by the FDA
Sep 14, 2009
Recalling firm
I-Flow Corporation
Quantity
4,450 Distributed
Product code
MEB
FDA submissions
K052117
Distribution
Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.

Product description

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 (models, lots, serial numbers)

Lot Number: 612996.

Other devices under the same FDA submission

31 devices cleared under K052117 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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