Smiths Medical recalls Medfusion 3500 syringe pumps with specific model numbers and serials manufactured between July 2016 and April 2021 that may have a molding defect in the barrel clamp guide, potentially causing pump to misidentify syringe size or fail to recognize syringe.
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Smiths Medical is recalling certain Medfusion 3500 syringe pumps that were manufactured or serviced with a specific barrel clamp guide part (G6000716) between July 2016 and April 2021. These pumps may have a molding defect that could cause the pump to misidentify the syringe size or fail to recognize the syringe, which could lead to incorrect medication dosing.
The pumps may have a molding defect in the barrel clamp assembly that causes the spring to slip. If this occurs, the pump might not recognize the syringe being used or could misidentify the syringe size, potentially leading to incorrect medication dosing.
Users of Medfusion 3500 syringe pumps with specific model numbers and serial numbers manufactured between July 2016 and April 2021 are affected. Healthcare professionals and patients using these pumps for medication delivery are at risk of incorrect dosing if the pump misidentifies the syringe.
Check if your Medfusion 3500 syringe pump has model numbers a) 3500 through l) 3500-500 and serial numbers listed in the recall notice. The pumps were manufactured or serviced with barrel clamp guide part number G6000716 between July 2016 and April 2021.
Compare your pump's model number and serial number with the list provided in the recall notice to determine if it is affected.
Reach out to Smiths Medical directly to confirm if your pump is affected and to get instructions on next steps.
The pumps may have a molding defect in the barrel clamp assembly that causes the spring to slip, potentially leading to the pump misidentifying the syringe size or failing to recognize the syringe.
Check if your Medfusion 3500 pump has model numbers a) through l) and serial numbers listed in the recall notice. The pumps were manufactured or serviced with barrel clamp guide part number G6000716 between July 2016 and April 2021.
Contact Smiths Medical directly to confirm if your pump is affected and to get instructions 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-1540-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1540-2024 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.
