Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 6) for updated cleaning instructions to ensure safe use.
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Baxter is recalling its SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 6) to update cleaning instructions. This update ensures safe use of the device and prevents potential safety issues.
The hazard involves potential safety issues if cleaning practices are not updated as per the new instructions. This could lead to improper device function or contamination risks if not handled correctly.
Healthcare professionals using Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 6) are affected. Patients receiving infusions through these pumps may be at risk if cleaning procedures are not followed correctly.
Check for the product code 35700ABB and all serial numbers on the pump. The device is sold with GTIN 00085412091570.
Check the updated instructions for proper cleaning procedures to ensure safe use of the pump.
The recall is for updated cleaning instructions to ensure safe use, not a safety hazard.
No, you can continue using it as long as you follow the updated cleaning instructions.
Look for product code 35700ABB and all serial numbers on the pump, or 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-0120-2021 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0120-2021 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.
