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Completed

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 Z-1139-2019 · Posted None

Recalling FirmPintler Medical LLC
Recall StatusCompleted
Product CodeDWJ
Date Initiated2018-04-20
Product Quantity24

Reason for Recall

Malfunction warming pad.

Firm Action

RECALL was isolated to the warming pads at this facility 100% of the pads were returned. Pintler Medical complaint logs- which includes reports from Field Reps, rework, customer feedback- calls/emails on site visits, show no previous occurrence of a like or similar event. Pintler Medical principal has been in regular communication, phone, email and 2 facility visits with the reporting facilities identified point QA team. We have kept them informed to action taken, results of root cause analysis. All 24 warming pads are being replaced. If you have any questions, contact Quality Assurance Principal at 406-859-0441 or email: [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to state of: Wisconsin.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113705PINTLER PATIENT WARMING SYSTEMPintler Medical · 2012-08-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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