FDAFDA · Food and drugs·Recall number Z-1139-2019
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
Published April 24, 2019 · Recall initiated: April 20, 2018
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Malfunction warming pad.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Pintler Medical LLC
- Distributor
- US Distribution to state of: Wisconsin.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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