Recall Z-0599-2018— 3M Company - Health Care Business

Name: FDA recall Z-0599-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-23

Class II · Terminated

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2018-01-23, terminated 2020-08-21. It names one FDA 510(k) clearance: K060865. 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 conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.. Reason: 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..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Terminated
Initiated: 2018-01-23
Terminated: 2020-08-21
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K060865 — BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850Arizant Healthcare, Inc.·cleared 2006-04-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.