The Recall Desk

FDA (Devices) recall action 67225

GE Healthcare recalled 6 products on 2014-02-12

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2014-02-12
Critical
0
Units
12,201

Why these products were recalled

Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

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

1–6 of 6

  • HighFDA (Devices)··2014-02-12

    GE Healthcare Recalls Infant Resuscitation T-Piece Upgrade Kits

    GE Healthcare is recalling 561 infant resuscitation T-piece upgrade kits because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

    Product
    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-02-12

    GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

    GE Healthcare is recalling 48 Stand-Alone Resuscitation Units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-02-12

    GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

    GE Healthcare is recalling 15 infant resuscitation units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

    Product
    Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-02-12

    GE Healthcare Panda Infant Warmers Recalled for Loose Adjustment Knob

    GE Healthcare is recalling Panda iRes and Freestanding Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-02-12

    GE Healthcare Recalls Giraffe Infant Warmers Due to Loose Adjustment Knob

    GE Healthcare is recalling 1,970 Giraffe Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-02-12

    GE Healthcare Recalls Stand-Alone Resuscitation T-Pieces Due to Loose Knob

    GE Healthcare is recalling 375 Stand-Alone Resuscitation T-Pieces because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road…
    Category
    Distribution
    1 state