Recall Z-2536-2018— Bard Medical Division
Class II · Terminated
Class II FDA medical device recall by Bard Medical Division, initiated 2018-06-13, terminated 2021-02-16. It names one FDA 510(k) clearance: K161602. Product: Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.. Reason: An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system..
- Recalling firm
- Bard Medical Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-13
- Terminated
- 2021-02-16
- Firm location
- Covington, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.
Reason for recall
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.