Baxter recalls Sigma Spectrum Infusion Pumps with Master Drug Library (Version 6) due to missing air-in-line and occlusion detection tests, which could cause serious health issues.
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
Baxter is recalling its Sigma Spectrum Infusion Pumps with Master Drug Library (Version 6) because service technicians incorrectly documented final testing, omitting critical safety checks. This could lead to serious health problems if air or blockages in the pump aren't detected properly.
The pump may fail to detect air in the fluid line or blockages in the tubing at critical flow rates, which could cause serious health issues like incorrect dosing or complications during treatment.
Patients using Baxter Sigma Spectrum Infusion Pumps with Master Drug Library (Version 6) are affected. Healthcare providers and patients receiving infusion therapy are most at risk.
Check for the model number 35700BAXRE on the pump. The pump was sold with serial number 758477. This specific version (Version 6) includes the Master Drug Library.
Look for the model number 35700BAXRE on the pump to confirm it is the recalled version.
Reach out to Baxter Healthcare Corporation for guidance on next steps if you have the recalled pump.
The pump was recalled because service technicians improperly documented final testing, omitting critical safety checks for air-in-line and occlusion detection.
Improper detection could lead to serious health consequences, such as incorrect dosing or complications during infusion therapy.
Check for the model number 35700BAXRE and the serial number 758477 on the pump.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1667-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1667-2018 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.
