The Recall Desk

FDA (Devices) recall action 86047

CME America, LLC recalled 6 products on 2020-12-09

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
2020-12-09
Critical
0
Units
25,092

Why these products were recalled

Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.

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)··2020-12-09

    CME America T-Syringe Pump Recalled for Motor Wear and Hardware Damage

    CME America is recalling T-Syringe Pumps because motor wear may cause silent under-infusion and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous…
    Category
    Distribution
    26 states
  • SevereFDA (Devices)··2020-12-09

    CME America Recalls NeoThrive Syringe Pumps Due to Motor Wear

    CME America is recalling 4,182 NeoThrive syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.

    Product
    CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous…
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2020-12-09

    CME America T-Syringe Pump Recalled for Motor Wear and Fluid Damage

    CME America is recalling 4,182 T-Syringe Pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous…
    Category
    Distribution
    26 states
  • SevereFDA (Devices)··2020-12-09

    CME America T-Syringe Pump Recall for Motor Wear and Fluid Damage

    CME America is recalling T34L PCA syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.

    Product
    CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous…
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2020-12-09

    CME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks

    CME America is recalling 4,182 Neofeed syringe pumps because motor wear may cause under-infusion without alarms and cracks may allow cleaning fluids to damage hardware.

    Product
    CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous…
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2020-12-09

    CME America T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks

    CME America is recalling 4,182 T-Syringe Pump T34 units because motor wear may cause silent under-infusion and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous…
    Category
    Distribution
    26 states