Pintler Medical LLC recalls A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condit…
- Recall date
- April 20, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1139-2019
- FDA classification
- Class II
- Brand / firm
- Pintler Medical LLC
- Sold / distributed
- US Distribution to state of: Wisconsin.
Why it was recalled
Malfunction warming pad.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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