Reported Mar 21, 2018 · Terminated

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX…

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 711 Park Ave · Medina, NY · 14103-1036

Is this the product you have?

  • Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570)
  • Model Numbers35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids
Lot codes and dates
  • 4,613 of 4,613 codes

    • 700000
    • 700001
    • 700008
    • 400012
    • 700014
    • 700015
    • 700038
    • 400040
    • 400044
    • 400057
    • 700060
    • 400068
    • 700070
    • 400073
    • 400076
    • 700078
    • 700079
    • 400085
    • 700088
    • 700099
    • 700105
    • 400106
    • 400114
    • 700117
    • 700131
    • 700137
    • 400141
    • 700148
    • 700180
    • 700194
    • 700197
    • 400226
    • 700227
    • 700228
    • 700229
    • 700232
    • 700236
    • 700239
    • 400245
    • 700252
    • 700254
    • 700260
    • 700262
    • 700274
    • 400282
    • 700291
    • 700300
    • 700305
    • 700306
    • 400311
    • 700313
    • 700336
    • 700347
    • 700351
    • 700352
    • 400355
    • 700356
    • 700358
    • 400368
    • 700374
    42
Amount recalled
173,375

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 11, 2019 · Data as of Sep 19, 5:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.