Baxter recalls SIGMA Spectrum infusion pumps with Master Drug Library (Version 6) due to potential flow rate inaccuracies that could cause over- or under-infusion of fluids. Affected units may pose serious health risks during medical treatment.
The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.
Baxter is recalling its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) because improper flow rate testing before release might cause inaccurate fluid delivery. This could lead to over- or under-infusion of medications, potentially causing serious health issues for patients receiving treatment.
The pump's flow rate test verification was not properly executed before release. This means the pump might not accurately measure fluid delivery, leading to over- or under-infusion of medications. The risk depends on the patient's treatment and health conditions, potentially causing serious health issues.
Healthcare professionals using the pump in hospitals, outpatient care, homecare, or ambulatory settings are most at risk. Patients receiving fluid therapy through this pump could experience serious health consequences if the pump delivers incorrect medication amounts.
Look for the product code 35700BAX on the pump. This model is used for controlled fluid administration in hospitals, outpatient care, homecare, and ambulatory settings. The pump has a Master Drug Library (Version 6) feature.
Verify the product code on the pump's label to confirm it is 35700BAX with Master Drug Library (Version 6).
Reach out to Baxter Healthcare Corporation for guidance on next steps if you have the recalled pump.
The pump's flow rate test verification was not properly executed before release, which could lead to inaccurate fluid delivery and potential over- or under-infusion of medications.
Yes, depending on the patient's treatment and health conditions, the pump could cause serious health consequences if it delivers incorrect medication amounts.
Check for the product code 35700BAX on the pump's label. This model is used for controlled fluid administration in hospitals, outpatient care, homecare, and ambulatory settings.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1248-2019 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1248-2019 from Baxter. 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.
