Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.

Recall Insight

This FDA Devices action (record #Z-0971-2018) was formally reported on March 21, 2018, with the manufacturer initiating the action on October 6, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Medina, NY. Federal records indicate 173,375 units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion. Distribution data in the federal record shows the product reached: Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.