Baxter recalls SIGMA Spectrum Infusion Pump (Version 8) for updated cleaning instructions to prevent safety issues. No immediate action needed but follow new guidelines.
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Baxter is recalling its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) because they're updating cleaning instructions for safety. This update helps prevent potential safety issues during use.
The pump requires specific cleaning procedures to prevent safety issues. Baxter is updating the instructions to ensure proper cleaning practices are followed, reducing potential risks during use.
Healthcare professionals using the Baxter SIGMA Spectrum Infusion Pump (Version 8) with serial numbers starting with 35700BAX are affected. Patients receiving infusion treatments through this pump are at risk if cleaning practices aren't updated.
Check for the product code 35700BAX and serial numbers on the pump. This model was sold with the GTIN 00085412091570.
Follow the updated cleaning procedures provided by Baxter to ensure safe use of the pump.
No immediate danger is reported. Baxter is updating cleaning instructions for safety, not recalling the pump for a hazard.
No. The recall involves updating cleaning instructions, not stopping use.
Look for the product code 35700BAX and serial numbers on the pump. This model was sold with the GTIN 00085412091570.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0121-2021 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0121-2021 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.
