Date Initiated by Firm | April 20, 2018 |
Create Date | April 12, 2019 |
Recall Status1 |
Completed |
Recall Number | Z-1139-2019 |
Recall Event ID |
82531 |
510(K)Number | K113705 |
Product Classification |
System, thermal regulating - Product Code DWJ
|
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 |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Pintler Medical LLC 701 W Broadway St Philipsburg MT 59858
|
For Additional Information Contact | Maribeth Ellis 406-859-0441 |
Manufacturer Reason for Recall | Malfunction warming pad. |
FDA Determined Cause 2 | 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: Maribeth@pintlermedical.com. |
Quantity in Commerce | 24 |
Distribution | US Distribution to state of: Wisconsin. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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510(K) Database | 510(K)s with Product Code = DWJ
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