Recall Record

Louisville, CO, United States

Medivance Inc. recalls

2 recalls recorded since 2018, most recently on 27 June 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
27 June 2024
Reason
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.
Distribution
Worldwide - US Nationwide distribution including in the states of IN, OK, MO, FL, CT, KS, TX, NJ, CA, OR, HI, IL, WI, VA, KY, NH, CO, NV, LA, NC, ID, UT, GA, SC, TN, MD, PA, IA, MA, OH, NY, DE, MI, NM, WV, AZ, DC, VT, MN, SD, AL, AR, WA, NE, ND, MT, AK, MS, ME, WY, RI, PR, OK, OR and the countries o
Initiated
Voluntary: Firm initiated
Recall number
Z-2457-2024

Ongoing Class II Medical devices

Recall started
16 February 2024
Reason
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
Distribution
Worldwide - US Nationwide distribution including in the states of IL, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Australia, Singapore, South Korea, Ta
Initiated
Voluntary: Firm initiated
Recall number
Z-1381-2024

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.