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
- Recall Number
- Z-1139-2019
- Event Number
- 82531
- Firm
- Pintler Medical LLC
- FEI Number
- 3009976772
- Product Code
- DWJ
- Status
- Completed
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 20, 2018
- Address
- 701 W Broadway St, Philipsburg, MT, 59858
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
Malfunction warming pad.
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].
US Distribution to state of: Wisconsin.
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