FDA Device recall Z-2113-2018

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum…

• FDA Device
• Class II
• terminated
• Published 2018-06-13

On 2018-06-13 the FDA classified a Class II recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum… by Baxter Healthcare, citing 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 perf….

Read the official FDA Device notice

Product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2113-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.