Baxter recalls Sigma Spectrum Infusion Pumps with Master Drug Library (Version 6) 35700BAXR 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 specific models of its Sigma Spectrum Infusion Pumps with Master Drug Library (Version 6) because service technicians incorrectly documented that all safety tests were completed. This omission could lead to serious health risks if air or blockages in the tubing are not detected properly.
The pumps were improperly tested, missing critical checks for air in the tubing and blockages. If these issues aren't detected, the pumps might deliver unsafe fluids, potentially causing serious health problems like blood clots or tissue damage.
Healthcare professionals using Baxter Sigma Spectrum Infusion Pumps with Master Drug Library (Version 6) 35700BAXR are most at risk. Patients receiving infusions through these pumps could face serious health consequences if air or blockages are not detected.
Check for serial numbers listed in the recall: 745365, 750241, 750330, and other numbers provided in the record. These pumps were sold with the Master Drug Library (Version 6) software.
Look for the serial numbers listed in the recall: 745365, 750241, 750330, and other numbers provided in the record.
Baxter technicians incorrectly documented that all safety tests were completed, missing critical checks for air in the tubing and blockages. This could lead to serious health risks if these issues aren't detected.
The Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR, with serial numbers listed in the recall.
Patients receiving infusions through these pumps could face serious health consequences if air or blockages in the tubing are not detected properly.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1665-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1665-2018 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.
