Smiths Medical recalls Medfusion Model 4000, 3500, and 3010 pumps with specific barrel clamp parts that may slip, causing pump errors. Affected units include Lot Numbers P0407365, P0486670, P0561740.
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 Medfusion pumps with a specific barrel clamp part that might slip, causing the pump to misidentify syringes. This could lead to incorrect dosing if the pump doesn't recognize the syringe properly.
The barrel clamp part may have a molding defect that causes the spring to slip. If the spring slips, the pump might not recognize the syringe or misidentify its size, leading to incorrect dosing.
Users of Medfusion Model 4000, 3500, and 3010 pumps with the specified barrel clamp part (Part Number G6000716) and Lot Numbers P0407365, P0486670, P0561740 are affected. Patients using these pumps are most at risk of incorrect dosing.
Check if your Medfusion pump has the Barrel Clamp Guide (Part Number G6000716) and the Lot Numbers P0407365, P0486670, or P0561740.
Identify your Medfusion pump model and the Lot Number of the Barrel Clamp Guide part.
Medfusion Model 4000, 3500, and 3010 pumps with the Barrel Clamp Guide (Part Number G6000716) and Lot Numbers P0407365, P0486670, or P0561740.
The barrel clamp part may have a molding defect that causes the spring to slip, potentially leading to the pump misidentifying syringe size or failing to recognize the syringe.
The recall record does not specify a remedy, so check with Smiths Medical for guidance.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1543-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1543-2024 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.