Smiths Medical recalls Medfusion plunger cases produced before April 2022 due to potential force sensor calibration issues causing false alarms or system failures. Affected units have specific lot numbers.
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
Smiths Medical is recalling plunger cases for infusion pumps that were made before April 2022. These cases might cause false alarms or system failures if the force sensor calibration drifts over time.
The force sensor in the plunger case may drift out of calibration, causing the pump to either delay detecting blockages or trigger false alarms. This issue is more likely in units made before April 2022 due to mechanical interference in the plunger head assembly.
Infusion pump users who own the recalled plunger cases (model G6001587) are most at risk. The recall affects patients using these pumps for medical treatments.
Check if your Medfusion plunger case has the component number G6001587 and was produced before April 2022. Affected units have specific lot numbers listed in the recall notice.
Look for the lot numbers P0084727, P0104753, P0106429, P0132050, P0166387, P0170765, P0171220, P0181073, P0243080, or P0284277 on the case.
The force sensor may drift out of calibration, causing false occlusion alarms or delayed blockage detection in infusion pumps made before April 2022.
Check the lot number on your case to see if it's affected. If it is, contact Smiths Medical for further instructions.
The recall states that shifts in calibration may occur over time, but the risk of serious injury is not described as high. The hazard is more about potential false alarms or system failures.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0081-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0081-2024 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.
