Medivance Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-Class IIJun 27, 2024If temperature management system fails to reach correct targ	If temperature management system fails to reach correct target water temperature while device is operating in	Class IIDevices	Jun 27, 2024
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CClass IIFeb 16, 2024Neonatal pads are experiencing reduced water flow, which may	Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling perfo	Class IIDevices	Feb 16, 2024