The Recall Desk

FDA (Devices) recall action 67921

Codman & Shurtleff, Inc. recalled 2 products on 2014-05-21

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
2014-05-21
Critical
0
Units
124

Why these products were recalled

A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

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.

1–2 of 2

  • ModerateFDA (Devices)··2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 90 MedStream Programmable Infusion Pumps because a small number may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 34 MedStream Programmable Infusion Pumps because they may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Distribution
    0 states