Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) due to 12.5-inch hangers supplied with secondary sets, which may not lower primary bag 20 inches below secondary bag as required. This could affect infusion safety.
The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.
Baxter is recalling its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) because the supplied hangers are only 12.5 inches long, not the 20 inches needed to safely position the primary bag below the secondary bag. This could lead to improper infusion rates if the hanger is too short.
The product requires lowering the primary bag 20 inches below the secondary bag using a hanger during secondary infusions. However, the supplied hangers are only 12.5 inches long, which may not allow the primary bag to be positioned correctly. This could lead to improper infusion rates if the hanger is too short.
Healthcare professionals using Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) for fluid administration are affected. Those using the pumps with the supplied 12.5-inch hangers are most at risk.
Check for the product name 'Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)' and serial numbers manufactured from July 1, 2014, onward.
Check the current Instructions for Use to confirm the correct hanger length for your pump model.
The recall is due to the supplied hangers being 12.5 inches long instead of the required 20 inches for proper positioning of the primary bag below the secondary bag during secondary infusions.
No, the recall does not require stopping use. The firm is updating the Instructions for Use to address the hanger size issue.
Review the current Instructions for Use to confirm the correct hanger length for your pump model.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-2113-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-2113-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
