Recall Z-1139-2019 ยท DWJ System, Thermal Regulating
Pintler Medical LLC
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
| Date | Apr 20, 2018 |
| Status | Completed |
| Reason | Malfunction warming pad. |
| Root cause | Nonconforming Material/Component |
| 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 Prin |
| Quantity | 24 |
| Distribution | US Distribution to state of: Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113705 | PINTLER PATIENT WARMING SYSTEM Pintler Medical, Aug 31, 2012 |