The Recall Desk

FDA (Devices) recall action 79002

3M Company - Health Care Business recalled 2 products on 2018-02-21

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
2018-02-21
Critical
0
Units
—

Why these products were recalled

Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.

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

1–2 of 2

  • HighFDA (Devices)··2018-02-21

    3M Bair Hugger Warming Blanket Recall for Airflow Occlusion Risk

    3M is recalling Bair Hugger warming blankets because a design change may cause airflow blockage, leading to limited inflation during use.

    Product
    3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-02-21

    3M Bair Hugger Underbody Blanket Recall for Airflow Occlusion Risk

    3M is recalling Bair Hugger Normothermia System blankets due to a design change that may cause unintended airflow occlusion and limited inflation.

    Product
    3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when
    Category
    Distribution
    0 states