The Recall Desk

FDA (Devices) recall action 65420

Codman & Shurtleff, Inc. recalled 2 products on 2013-07-24

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
2013-07-24
Critical
2
Units
—

Why these products were recalled

Miscalibrated Fill Level Sensor may affect dosing level

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • CriticalFDA (Devices)··2013-07-24

    Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor

    Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.

    Product
    MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
    Category
    Distribution
    4 states
  • CriticalFDA (Devices)··2013-07-24

    Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor

    Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.

    Product
    MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
    Category
    Distribution
    4 states