TherMax Blood Warmer Unit
Reported: November 6, 2019 Initiated: September 19, 2019 #Z-0247-2020
Product Description
TherMax Blood Warmer Unit
Reason for Recall
TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 504 units total
- Distribution
- Nationwide distribution to Georgia and Maryland. International distribution to Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Australia, and New Zealand
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
TherMax Blood Warmer Unit. Recalled by Baxter Healthcare Corporation. Units affected: 504 units total.
Why was this product recalled? ▼
TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2019. Severity: Moderate. Recall number: Z-0247-2020.
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