FDA Enforcement
Class II
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
Recall: Z-1139-2019
·
Reported April 24, 2019
Enforcement
- Recall Number
- Z-1139-2019
- Event ID
- 82531
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Pintler Medical LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- April 24, 2019
- Initiation Date
- April 20, 2018
- Classification Date
- April 12, 2019
- Address
- 701 W Broadway St, N/A, Philipsburg, MT, 59858, United States
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
Reason
Malfunction warming pad.
Code Info
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
Distribution
US Distribution to state of: Wisconsin.
Quantity
24