Reported Apr 24, 2019 · Completed

A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any…

Pintler Medical LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pintler Medical LLC · 701 W Broadway St · Philipsburg, MT · 59858

Is this the product you have?

  • 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
Lot codes and dates

5 of 5 products

Products covered by this recall
Model / numberProduct as published
PIN-BH85Lot Number 27473 Quantity in lots 12
PIN-SKY67-OSLot Number 27590 Quantity in lots 6
PIN-LG78-OSLot Number 27544 Quantity in lots 2
Lot Number 27634 Quantity in lots 3 Part Number PIN-SUMMIT, and
Lot Number 27498 Quantity in lots 1 Part Number PIN-PEDS
Amount recalled
24

Where it was sold

Why it was recalled

Malfunction warming pad.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 PM UTC

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