Smiths Medical recalls Medfusion Syringe Pump 3500 Series models that may misidentify loaded medication syringes, causing incomplete programming. 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 Medfusion Syringe Pump 3500 Series models that may not recognize or misidentify loaded medication syringes. This can prevent the pump from completing programming, potentially leading to incorrect medication delivery.
The pump may not recognize the size of loaded medication syringes or misidentify them, which prevents the pump from completing programming. This could lead to incorrect medication delivery or incomplete treatment.
Healthcare professionals using Medfusion Syringe Pump 3500 Series models for medication administration are most at risk. Patients receiving treatments via these pumps could be affected if the pump misidentifies syringes.
Check for product codes 3500G, 3500VX, 3500-414, 3500-402, 3500-0600-249, 3500-0600-00, 3500-0600-01, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-415, or 3500-500. These models were sold for medical use in critical care, anesthesia, neonatal, and pediatric settings.
Identify if your pump has any of the listed product codes: 3500G, 3500VX, 3500-414, 3500-402, 3500-0600-249, 3500-0600-00, 3500-0600-01, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-415, or 3500-500.
The recall affects Medfusion Syringe Pump 3500 Series models with product codes 3500G, 3500VX, 3500-414, 3500-402, 3500-0600-249, 3500-0600-00, 3500-0600-01, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-415, or 3500-500.
Certain models may not recognize or misidentify loaded medication syringes, which can prevent the pump from completing programming and potentially lead to incorrect medication delivery.
Check your pump's product code against the list provided. If affected, contact Smiths Medical for guidance on next steps.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1135-2018 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1135-2018 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.
