Recall Z-1139-2019
Pintler Medical LLC · initiated April 20, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Number 27473 Quantity in lots 12 Part Number PIN-BH85, Lot Number 27590 Quantity in lots 6 Part Number PIN-SKY67-OS, Lot Number 27544 Quantity in lots 2 Part Number PIN-LG78-OS, Lot Number 27634 Quantity in lots 3 Part Number PIN-SUMMIT, and Lot Number 27498 Quantity in lots 1 Part Number PIN-PEDS
Reason for recall
Malfunction warming pad.
FDA-determined cause: Nonconforming Material/Component
Action taken
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: Maribeth@pintlermedical.com.
Details
- Recall number
- Z-1139-2019
- Initiated
- April 20, 2018
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 24
- Distribution
- US Distribution to state of: Wisconsin.
- Recalling firm
- Pintler Medical LLC, Philipsburg, MT