Baxter recalls SIGMA Spectrum Infusion Pump (Version 8) for updated cleaning instructions to ensure safe use. This update addresses safety communication for cleaning practices.
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) due to updated cleaning instructions for safety. This update helps prevent potential issues with the device's operation.
The device requires specific cleaning practices to prevent potential issues with its operation. Updated instructions aim to ensure safe use by addressing safety concerns related to cleaning procedures.
Healthcare professionals using the Baxter SIGMA Spectrum Infusion Pump (Version 8) are affected. Patients receiving infusions through this device may be at risk if cleaning practices are not followed correctly.
Check for the product code 35700BAX2 and all serial numbers on the pump. The device was sold with GTIN 00085412498683.
Check the updated device IFU for cleaning practices to ensure safe use.
The recall involves updated cleaning instructions for safety, not a hazard that causes injury. The risk is low.
Look for product code 35700BAX2 and all serial numbers on the pump. The device was sold with GTIN 00085412498683.
No, the recall is for updated cleaning instructions, not a stop-use order.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0122-2021 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0122-2021 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.
