Z-1139-2019Class II

A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in...

Name: Z-1139-2019 A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in...
Creator: Pintler Medical LLC
Published: 2018-04-20
License: https://open.fda.gov/license/

Pintler Medical / initiated 2018-04-20 / Completed / root cause: manufacturing process

FDA source

Pintler Medical LLC began a recall of 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... on 2018-04-20. FDA classified it as Class II and gives the reason as "Malfunction warming pad". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1139-2019
Classification: Class II
Status: Completed
Initiated: 2018-04-20
Posted: 2019-04-12
Recalling firm: Pintler Medical
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
Product code: DWJ System, Thermal Regulating
Reason for recall: Malfunction warming pad.
Root cause tag: manufacturing process
FDA 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 Principal at 406-859-0441 or email: [email protected].
Quantity in commerce: 24
Distribution: US Distribution to state of: Wisconsin.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1139-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1139-2019	Class II	Completed	Voluntary: Firm initiated	2019-04-24	2019-04-12

Product code DWJ

K113705Class IIPintler Patient Warming SystemPintler Medical / cleared 2012-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)