FDA Device recall Z-1139-2019
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad
- FDA Device
- Class II
- completed
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad by Pintler Medical, citing malfunction warming pad.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1139-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2018-04-20 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Pintler Medical |
| Distribution | WI |
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
Reason
Malfunction warming pad.
Identifiers
| code_info | Lot Number 27473 Quantity in lots 12 Part Number PIN-BH85, Lot Number 27590 Quantity in lots 6 Part Number PIN-SKY67-O…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1139-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.