Smiths Medical recalls Medfusion Syringe Pump 4000 Series models that may misidentify loaded syringes, causing programming issues. Affected units include specific product codes.
Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.
Smiths Medical is recalling certain Medfusion Syringe Pump 4000 Series models because they may not recognize or misidentify loaded medication syringes. This can prevent proper pump programming and lead to incorrect medication delivery.
The pumps may not recognize the size of loaded syringes or misidentify them, which prevents the pump from completing programming. This could lead to incorrect medication delivery if the pump fails to adjust properly.
Healthcare professionals using Medfusion Syringe Pump 4000 Series models in clinical settings are most at risk. Patients receiving medication via these pumps could be affected if the pump misidentifies syringe size.
Check for product codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01. These pumps are used in critical care, anesthesia, and pediatric settings.
Identify if your pump has one of the listed product codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01.
The affected models are the Medfusion Syringe Pump 4000 Series with product codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01.
The pumps may not recognize or misidentify loaded medication syringes, which can prevent proper programming and lead to incorrect medication delivery.
Check your pump's product code to see if it is affected. If it is, contact Smiths Medical for further instructions.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1134-2018 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1134-2018 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
