The Recall Desk

FDA (Devices) recall action 68318

Hospira Inc. recalled 4 products on 2016-07-20

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-07-20
Critical
0
Units
106,513

Why these products were recalled

Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.

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

1–4 of 4

  • SevereFDA (Devices)··2016-07-20

    Hospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure

    Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.

    Product
    LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a
    Category
    Distribution
    53 states
  • SevereFDA (Devices)··2016-07-20

    Hospira Recalls LifeCare PCA Plus II Infusion Pumps Due to Occlusion Detection Failure

    Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.

    Product
    The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncol
    Category
    Distribution
    53 states
  • SevereFDA (Devices)··2016-07-20

    Hospira PCA 3 Infusion Pump Recall for Occlusion Detection Failure

    Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one serious injury.

    Product
    The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 inf
    Category
    Distribution
    53 states
  • SevereFDA (Devices)··2016-07-20

    Hospira LifeCare Pump Model 4200 PCA Infuser Recalled for Occlusion Detection Failure

    Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.

    Product
    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA
    Category
    Distribution
    53 states