Baxter recalls certain SIGMA Spectrum Infusion Pumps with Master Drug Library (Version : flow testing may not be complete after repair. Affected units have specific product codes and serial numbers.
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Baxter is recalling some SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 6) because they were released after repair without full testing, including flow testing. This could lead to improper medication delivery if the pump malfunctions.
The pumps were released after repair without full testing, which includes flow testing. This means the pump might not deliver medication correctly, potentially causing improper dosing or treatment.
Healthcare providers using the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) are likely affected. Patients receiving medication through this pump are at risk if the device malfunctions.
Check for the product code 35700BAX, GTIN 00085412091570, or serial number 779515 on the pump. These specific identifiers indicate the recalled units.
Identify the product code, GTIN, or serial number on your pump to confirm if it is recalled.
The recall indicates that pumps were released after repair without full testing, which could lead to improper medication delivery. However, the specific risk level is not detailed in the notice.
Check for the product code 35700BAX, GTIN 00085412091570, or serial number 779515 on your pump.
The recall notice does not specify a remedy, so you should check the pump details to see if it is affected.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0775-2025 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0775-2025 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.
