5 results
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43ms
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Sources: EU EUDAMED, US FDA
Pintler Patient Warming System
FDA UDI
PINTLER MEDICAL, LLC·B389PPWS0011·The Pintler Patient Warming System a thermal re...
PINTLER PATIENT WARMING SYSTEM
FDA Adverse Event
Malfunction
·PINTLER MEDICAL, LLC·Product code DWJ·May 1, 2018
PEAK OR WARMING PAD
FDA Adverse Event
Malfunction
·PINTLER MEDICAL, LLC·Product code DWJ·April 16, 2018
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
FDA Recall
Completed
·Pintler Medical LLC·Product code DWJ·April 20, 2018
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
FDA Enforcement
Class II
·Completed·Pintler Medical LLC·April 24, 2019