Baxter recalls SIGMA Spectrum Infusion Pumps (35700BAX/35700ABB) with 12.5-inch hangers that may not lower primary bag 20 inches below secondary bag, risking improper fluid administration.
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 certain SIGMA Spectrum Infusion Pumps that come with 12.5-inch hangers instead of the required 20-inch hangers. This could lead to improper fluid administration during medical treatments if the hanger height isn't correct.
The pump requires a 20-inch hanger to lower the primary bag below the secondary bag during secondary infusions. However, the recalled units come with 12.5-inch hangers, which may not achieve the correct height difference. This could lead to improper fluid administration if the hanger is too short.
Healthcare professionals using the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) for fluid administration. Patients receiving treatments through this pump are at risk if the hanger height is incorrect.
Check for product serial numbers manufactured between November 1, 2005, and April 22, 2013, with release dates from January 1, 2005, forward. The product model numbers are 35700BAX and 35700ABB.
Verify the serial number was manufactured between November 1, 2005, and April 22, 2013, with a release date from January 1, 2005, forward.
The pump comes with 12.5-inch hangers instead of the required 20-inch hangers, which could lead to improper fluid administration during secondary infusions.
Check the product serial number to see if it falls within the recall range. If it does, contact Baxter for further instructions.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-2112-2018 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-2112-2018 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.
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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.
