The Recall Desk

FDA (Devices) recall action 79815

Baxter Healthcare Corporation recalled 5 products on 2018-05-16

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2018-05-16
Critical
0
Units
2,220

Why these products were recalled

Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.

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

1–5 of 5

  • HighFDA (Devices)··2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Incomplete Testing Documentation

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because final release testing was improperly documented, omitting critical safety checks.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted required safety tests, potentially compromising air and occlusion detection.

    Product
    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recall Due to Testing Documentation Errors

    Baxter is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted specific safety tests. The missing tests for air and occlusion detection could lead to serious health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2018-05-16

    Baxter Infusion Pump Recalled for Improper Testing Documentation

    Baxter Healthcare Corporation is recalling 444 Sigma Spectrum Infusion Pumps because service technicians omitted required release tests, which could lead to serious adverse health consequences.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-05-16

    Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors

    Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians incorrectly documented that all final release tests were completed, when several were actually omitted.

    Product
    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
    Category
    Distribution
    1 state