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U.S. Department of Health and Human Services

Medical Devices

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WalkMed, Inc. Triton Pole Mount Infusion Pump

Recall Class: Class I

Date Recall Initiated: June 16, 2010

Product: Triton Pole Mount Infusion Pump

The recall includes the serial numbers 001 through 500 and serial numbers TR1401 through TR 2559 manufactured and sold before June 2010.

Use: Indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, or home care environments.

Recalling Firm: WalkMed Infusion, LLC

Reason for Recall: It is possible the pump door may not be closed when the latch is down and the pump door open alarm may not alert the user to this condition. This may result in a free flow condition which may result in over delivery of therapy and lead to serious injury or death.

Public Contact: Consumers with questions may contact WalkMed Infusion at 1-303-420-9569 between the hours of 8:00 AM and 4:00 PM Mountain Time.

FDA District: Denver

FDA Comments:

All customers were notified in June regarding this issue, advising them of the possible malfunctioning alarm. There are new concerns of the door not properly closing even when users were following instructions for use on door closure. The firm will be sending new information on this recall by November 29, 2010.

Consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer either by contacting the firm directly or by contacting their distributor.

If customers must continue using the pump, they should visually confirm that the pump door is completely closed with a visual inspection and tug on the door to confirm it is securely closed after latching it.

If the pump door is correctly closed and latched, the user will not experience a free flow condition from this issue. WalkMed can make pumps available that have been upgraded to address this issue to swap out for affected pumps.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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