FDAClass IIDecember 25, 2013

Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 recall

Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids…

Why was Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 recalled?

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 po

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Medfusion¿ 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.

Product
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids…
Recalling firm
Smiths Medical ASD, Inc.
Quantity
9560 (8601 US, 959 OUS)
Distribution
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.
Recall date
December 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls