Baxter Healthcare recalled 585 SIGMA Spectrum Infusion Pumps on November 28, 2025, due to a defect that may cause over-infusion. The affected model is the 35700BAX2, which has been distributed nationwide. Users must stop using the device immediately and follow recall instructions.
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions. Notification method: Letter
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The recall includes the SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2. The pumps were distributed nationwide in the United States and are under a Class II recall. The defective grease affects 585 units.
The infusion pumps may have been released with defective grease on the cam and motor gears. This low-viscosity grease can lead to insufficient lubrication, causing premature wear and potentially resulting in over-infusion or a free-flow situation.
No specific injuries have been reported related to this recall. The potential risk of over-infusion poses a serious hazard to patients.
Stop using the affected infusion pumps immediately. Contact Baxter Healthcare Corporation for further instructions on the recall process and follow any guidelines provided by your healthcare provider.
For further information, contact Baxter Healthcare Corporation at 1-888-229-0001 or visit the official website.
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