Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intrav

Recall Insight

This FDA Devices action (record #Z-1490-2012) was formally reported on June 20, 2012, with the manufacturer initiating the action on July 6, 2011. It is classified under Critical severity (Class I), with a current status of Terminated. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Medina, NY. Federal records indicate 63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa. 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 14 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.