Smiths Medical recalls Medfusion Syringe Pump Model 3500 with Software V6.0 due to potential inaccurate medication delivery after certain infusion interruptions. Affected units have specific model numbers and software versions.
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Smiths Medical is recalling Medfusion Syringe Pump Model 3500 with Software Version V6.0 because it can deliver inaccurate medication doses after specific infusion interruptions. This could lead to incorrect medication amounts being administered, which may affect treatment safety.
The pump can deliver inaccurate medication doses if a specific sequence of events occurs after an interrupted bolus or loading dose. This means that during certain infusion interruptions, the pump might not deliver the correct amount of medication, potentially leading to under or over-dosing.
Patients using the Medfusion Syringe Pump Model 3500 with Software Version V6.0 are most at risk. Healthcare providers who administer medications with this pump may also be affected.
Check for model numbers 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, or 3500-0600-82 on the pump. The software version should be V6.0.
Look for the software version on the pump's display or label to confirm it is V6.0.
Contact Smiths Medical for software updates to correct the issue.
Model numbers 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, and 3500-0600-82.
Software Version V6.0.
Check the model number and software version on the pump. Affected units have specific model numbers listed and software version V6.0.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2735-2020 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2735-2020 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.
