The Recall Desk

FDA (Devices) recall action 64230

Hospira Inc. recalled 2 products on 2016-09-28

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-09-28
Critical
0
Units
8,863

Why these products were recalled

Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.

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

1–2 of 2

  • HighFDA (Devices)··2016-09-28

    Hospira LifeCare PCA 3 Pumps Recalled for Screw Rotation Error

    Hospira is recalling 69 LifeCare PCA 3 pumps due to a screw rotation error that stops infusion and triggers an alarm.

    Product
    LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2016-09-28

    Hospira LifeCare PCA Infusion System Recalled for Screw Rotation Error

    Hospira Inc. is recalling 8,794 LifeCare PCA Infusion Systems because a screw rotation error can cause the pump to alarm and stop infusion.

    Product
    LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
    Category
    Distribution
    2 states