Smiths Medical recalls Model 3010 syringe pumps with specific serial numbers manufactured between July 2016 and April 2021 that may have a barrel clamp defect causing syringe misidentification.
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 Model 3010 syringe pumps that were manufactured or serviced with a specific barrel clamp guide between July 2016 and April 2021. This defect could cause the pump to misidentify the syringe size or fail to recognize the syringe, which may lead to incorrect medication delivery.
The pump may have a molding defect in the barrel clamp assembly that causes the spring to slip. If this happens, the pump might not recognize the syringe properly or could misidentify the syringe size, potentially leading to incorrect medication delivery.
Healthcare professionals using Smiths Medical Model 3010 syringe pumps with serial numbers listed in the recall between July 2016 and April 2021 are most at risk. Patients receiving medication through these pumps could experience incorrect dosing if the pump misidentifies the syringe.
Check if your pump has a serial number listed in the recall: Protege Model 3010 (M03315, M03910), Medfusion Model 3010A (multiple serial numbers), or Protege UK Model 3010E (M05179). These pumps were manufactured or serviced with the affected barrel clamp guide between July 2016 and April 2021.
Identify your pump's serial number to see if it matches the listed numbers for the affected models.
Reach out to Smiths Medical for guidance on whether your pump is affected and what steps to take next.
The recall is due to a potential molding defect in the barrel clamp assembly that could cause the pump to misidentify the syringe size or fail to recognize the syringe.
Protege Model 3010, Medfusion Model 3010A, and Protege UK Model 3010E pumps with specific serial numbers manufactured or serviced between July 2016 and April 2021.
Check your pump's serial number against the list provided in the recall: Protege Model 3010 (M03315, M03910), Medfusion Model 3010A (multiple serial numbers), or Protege UK Model 3010E (M05179).
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1542-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1542-2024 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.
