SIGMA SPECTRUM Infusion Pump with Master Drug Library component — Class II medical device recall Z-0189-2014

Terminated recall by Baxter Healthcare Corp., reported 2013-11-20, distributed nationwide. Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Mas

Recall number	`Z-0189-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Baxter Healthcare Corp., Deerfield, IL, United States
Recall initiated	2013-09-24
Classified	2013-11-08
Reported by FDA	2013-11-20
Terminated	2016-11-09
Distributed	Nationwide (US)
Countries outside the US	CA
Quantity	346 units
Serial numbers	`1002325`, `1018432`, `1018436`, `1018737`, `433713`, `435563`, `704056`, `707290`, `715315`, `724216`, `740127`, `752318`, `752447`, `753675`, `754947`, `759766`, `765934`, `770034`, `772017`, `773470`, `776507`, `781016`, `781969`, `783352`, `783454` and 66 more

Product

SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

Reason for recall

Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0189-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.