Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-1139-2019

U.S. FDA — Device Enforcement · United States · 2018-04-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1139-2019
Date of alert
2018-04-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Pintler Medical LLC
Product category
device
Product type
Devices
Reported risk: Malfunction warming pad.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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