Recall Z-1139-2019— Pintler Medical LLC

Name: FDA recall Z-1139-2019
Creator: U.S. Food and Drug Administration
Published: 2018-04-20

Class II · Completed

Class II FDA medical device recall by Pintler Medical LLC, initiated 2018-04-20. It names one FDA 510(k) clearance: K113705. 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: Malfunction warming pad..

Recalling firm: Pintler Medical LLC
Classification: Class II
Status: Completed
Initiated: 2018-04-20
Firm location: Philipsburg, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K113705 — PINTLER PATIENT WARMING SYSTEMPintler Medical·cleared 2012-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.