Baxter recalls specific models of Sigma Spectrum Infusion Pumps (35700BAX) due to missing air-in-line and occlusion detection tests, which could cause serious health issues during use.
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 certain models of Sigma Spectrum Infusion Pumps with master Drug Library (Version 6) because service technicians improperly documented final testing. This omission could lead to serious health risks if air or blockages in the tubing are not detected properly.
The pumps were tested without critical checks for air in the tubing and blockages. If these issues aren't detected, the pump might deliver incorrect fluids, potentially causing serious health problems like incorrect dosing or blood clots.
Healthcare professionals and patients using Baxter Sigma Spectrum Infusion Pumps with master Drug Library (Version 6) model 35700BAX. Those with the specific serial numbers listed in the recall are most at risk.
Check if your pump has the model number 35700BAX and the specific serial numbers listed in the recall. These pumps are used for administering fluids like blood or medications intravenously.
Look for the serial number on the pump's label to confirm if it's in the list of affected units provided in the recall.
Reach out to Baxter Healthcare Corporation directly for instructions on whether your pump needs repair or replacement.
The recall is due to service technicians improperly documenting final testing, which omitted critical checks for air in the tubing and blockages. This could lead to serious health risks if these issues aren't detected.
The affected models are Baxter Sigma Spectrum Infusion Pumps with master Drug Library (Version 6) model 35700BAX, with specific serial numbers listed in the recall.
No, but you should check if your pump is in the list of affected units and contact Baxter for guidance on next steps.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1663-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1663-2018 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.
