The Recall Desk

FDA (Devices) recall action 75311

Baxter Healthcare Corp. recalled 3 products on 2016-12-07

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-12-07
Critical
0
Units
439

Why these products were recalled

A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.

A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2016-12-07

    Baxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies

    Baxter Healthcare is recalling 439 V6 Rear Case Assemblies for SIGMA Spectrum Infusion Pumps because the speakers may fail prematurely.

    Product
    V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-12-07

    Baxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure

    Baxter is recalling SIGMA Spectrum Infusion Pumps to replace speakers that may fail prematurely, potentially affecting audible alarm tones.

    Product
    Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-12-07

    Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk

    Baxter Healthcare is recalling 5,976 Sigma Spectrum Infusion Pumps because some speakers may fail prematurely, potentially affecting audible alarms.

    Product
    sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly…
    Category
    Distribution
    1 state