Smiths Medical recalls Medfusion Syringe Pump Models 3500 series (including specific software versions) due to potential interruptions in therapy or over-infusion risks. Affected units may display multiple alarm issues that could lead to incorrect dosing or system failures.
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
Smiths Medical is recalling several Medfusion Syringe Pump models (3500 series) because they can cause therapy interruptions or over-infusion risks. This happens due to multiple alarm system issues that might lead to incorrect dosing or system failures.
The pumps have multiple alarm system issues that can cause therapy interruptions or over-infusion. This means the pump might stop working unexpectedly or deliver too much medication without proper warning.
Patients using these syringe pumps for medical therapy, particularly those requiring continuous medication delivery. Healthcare providers who use these pumps for patient care are most at risk.
Check if your pump has a model number starting with '3500' and software version 6.0.0 or 6.0.1. The specific models listed include 3500, 3500-0600-00, 3500-0600-01, and others as detailed in the recall notice.
Identify your pump model by checking the serial number or model label on the device.
Reach out to Smiths Medical for assistance with the recall and potential remedies.
The recall includes Medfusion Syringe Pump Models 3500 series with specific model numbers and software versions 6.0.0 and 6.0.1.
The pumps have multiple alarm system issues that can cause therapy interruptions or over-infusion risks, potentially leading to incorrect dosing or system failures.
No, but you should check your pump model and 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-1272-2022 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1272-2022 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.
