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.
- Recall Initiated
- January 23, 2018
- Terminated
- August 21, 2020
- Recall Number
- Z-0599-2018
- Quantity
- 36 cases of 5 units
- Firm Location
- Saint Paul, MN
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.
Distribution
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican, Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand, and Uruguay.
Lot / Code Info
Lot Numbers: FR10361
Root Cause
Finished device change control
Action Taken
The firm, 3M, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 1/19/2018 to its customers on 01/23/2018. The end user letter requested the following: "Actions Required: 1) Please immediately identify the affected product listed above, remove from your inventory and DO NOT USE. 2) Follow the instructions on the attached Customer Product Recall Acknowledgement Form, complete the form and return it to 3M via email at 3Mhealthcare@montage72.com. 3) Please dispose of all affected product per your institutional protocol and document disposal in the recall acknowledgment form." The distributor letter requested the following: "Actions Required: 1. Immediately discontinue distribution of the 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, with the referenced lot numbers above. 2. Determine if any stock of the 3M" Bair Hugger" Full Access Underbody Warming Blanket, Models 63500 and 63700, with the referenced lot numbers above remains in your inventory. 3. Complete the attached Distributor Product Recall Acknowledgement Form and return to 3M via email at 3Mhealthcare@montage72.com. It is important to notify 3M whether or not your facility has any inventory of this product. 4. Notify any of your customers who may have received the lots. Please use the attached customer notice and form provided in your communications to the customer. Customers should complete and return the enclosed form to 3M per the instructions on the form. Customers should not use the affected product and dispose per institutional protocol. 5. Dispose of any affected product in your inventory and document disposal in the recall acknowledgment form." If you have questions regarding this matter, please contact the 3M Health Care Customer Helpline at 1-800-228-3957, option #6, Monday through Friday, 7:30 a.m. 6:00 p.m. Central Daylight Time.