Smiths Medical recalls Medfusion Plunger Float Plate (Component G6000069) due to potential force sensor calibration drift causing false alarms or delayed occlusion detection. Affected units sold before April 2022.
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 Medfusion Plunger Float Plates with component number G6000069 that may have calibration issues causing false alarms or delayed detection of blockages in infusion pumps. This could lead to improper medication delivery if the pump fails to detect a blockage in time.
The force sensor in the plunger float plate may drift out of calibration over time, especially in units produced before April 2022. This can cause the pump to either delay detecting blockages or trigger false alarms, potentially leading to improper medication delivery.
Infusion pump users who own the recalled plunger float plates (lot numbers listed) are most at risk. Healthcare providers using these components in medical devices are affected.
Check for the component number G6000069 on the plunger float plate. Affected units have specific lot numbers listed in the recall notice, including P0048777 through P0745394.
Look for the lot numbers listed in the recall: P0048777, P0067276, P0094724, P0102958, P0131089, P0266366, P0412271, P0725712, P0729657, P0744687, P0745394, P112621, P122904, P129485.
Smiths Medical reports potential force sensor calibration drift in units produced before April 2022, which could cause false alarms or delayed detection of blockages in infusion pumps.
Check if your plunger float plate has component number G6000069 and one of the listed lot numbers: P0048777 through P0745394.
No, the recall does not require immediate discontinuation. The hazard is low risk and does not cause serious injury in normal use.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0080-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0080-2024 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.
