Baxter recalls Sigma Spectrum Infusion Pumps (Version 6) with missing safety tests that could cause serious health issues if air or blockages aren't detected properly.
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 Sigma Spectrum Infusion Pumps with Master Drug Library (Version 6) because they were tested incorrectly, which might cause serious health problems if air or blockages aren't detected properly.
The pumps were improperly tested, meaning they might not detect air in the fluid line or blockages in the tubing at critical flow rates. This could lead to serious health issues if the pump fails to alert the user during treatment.
Healthcare professionals using the recalled pumps for administering fluids to patients are most at risk due to potential serious health consequences from undetected air or blockages.
Check for the model number 35700BAXRP on the pump. The affected units have serial numbers listed in the recall notice: 792177, 795979, 802612, 805938, 807209, 813365, 813367, 871387, 922364, 935968, 962932, 963087.
Look for the serial numbers listed in the recall: 792177, 795979, 802612, 805938, 807209, 813365, 813367, 871387, 922364, 935968, 962932, 963087.
The pumps were improperly tested, meaning they might not detect air in the fluid line or blockages in the tubing at critical flow rates, which could cause serious health issues.
Check the pump's serial number against the list provided in the recall notice. If it matches, stop using it and contact Baxter Healthcare Corporation for further instructions.
Yes, the pumps might not detect air or blockages properly, which could lead to serious health issues during treatment.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1666-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1666-2018 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.
