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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description Medfusion® 4000 Syringe Infusion Pumps Medfusion® 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
Recall Number Z-0540-2014
Classification Class II
Code Info All Medfusion® 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.
Product Distributed Qty 9546 (8587 US, 959 OUS)
Reason For Recall Smiths Medical is conducting a recall involving all Medfusion® 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC power receptacle. The pump and the AC power cord are constructed of flame retardant materials; therefore, the sparks/ flames extinguish within seconds. Smiths Medical has received no reports of injury or any damage beyond damage to the pump and AC power cord associated with this issue. If this issue occurs there is a potential for a delay in therapy while a replacement or alternative method of delivery is obtained.

Event Detail

Event Id 66987
Product Type Devices
Status Ongoing
Recalling Firm Smiths Medical ASD, Inc.
City Saint Paul
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA.
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