FDA recall Z-1139-2019

Product

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

Reason for recall

Malfunction warming pad.

Distribution

US Distribution to state of: Wisconsin.

Key facts

Status

Completed

Initiation date

2018-04-20

Report date

2019-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Philipsburg, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1139-2019